Ali-Flex Tablets

Generic Name: phenyltoloxamine citrate and acetaminophen

Dosage Form: tablet
Ali-Flex Dye Free Tablets 100 Tablets

DOSAGE:

Adults (12 years and older) - 1/2 or 1 tablet every 4 hours.

    Maximum daily dose - 5 tablets.

Children (6 to under 12 years) - 1/2 tablet every 4 hours.

    Maximum daily dose - 2 1/2 tablets.



Children under 6 years of age consult a physician.

STORAGE:Store at room temperature. Avoid excessive heat.

PHARMACIST:Preserve and dispense in tight containers with child resistant closures.

WARNING:Keep this and all drugs out of reach of children.

INDICATIONS: For the temporary relief of minor aches and pains associated with headaches, backaches, muscular aches, the menstrual and premenstrual periods, colds, the flu, toothaches, as well as for minor pain from arthritis, and to reduce fever.

WARNINGS: Do not take this product for pain for more than 10 days (adults) or 5 days (children) and do not take for fever for more than 3 days unless directed by a physician. If pain of fever persist, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health professional before using this product.

How Supplied:

Ali-Flex Tablets are white (dye-free) oblong scored tablets. They are debossed with ALI-FLEX on one side and scored on the other side. Supplied in bottle of 100. Rx only.

ALI-FLEX  acetaminophen and phenyltoloxamine citrate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 55246-816 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLTOLOXAMINE CITRATE (PHENYLTOLOXAMINE) PHENYLTOLOXAMINE CITRATE 50 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   MAGNESIUM STEARATE

Product Characteristics Color white (Dye Free) Score 2 pieces Shape BULLET (Oblong Tablet) Size 17mm Flavor Imprint Code AliFlex Contains

Packaging # NDC Package Description Multilevel Packaging 1 55246-816-49 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/27/2001	07/01/2012

Labeler - Pegasus Laboratories (007124357)

Establishment
Name	Address	ID/FEI	Operations
Pegasus Laboratories Inc		007124357	manufacture, analysis

Revised: 04/2010Pegasus Laboratories

More Ali-Flex Tablets resources

• Ali-Flex Tablets Side Effects (in more detail)
• Ali-Flex Tablets Dosage
• Ali-Flex Tablets Use in Pregnancy & Breastfeeding
• Ali-Flex Tablets Drug Interactions
• Ali-Flex Tablets Support Group
• 0 Reviews for Ali-Flexs - Add your own review/rating

Compare Ali-Flex Tablets with other medications

• Cold Symptoms
• Headache
• Influenza
• Pain

Alimta

Generic Name: Pemetrexed Disodium
Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: N-[4-2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-l-glutamic acid disodium salt.
Molecular Formula: C₂₀H₁₉N₅Na₂O₆
CAS Number: 150399-23-8

Introduction

Antineoplastic agent; a folic acid antagonist.^{1 3 4 5}

Uses for Alimta

Malignant Pleural Mesothelioma

Used in combination with cisplatin for the treatment of malignant pleural mesothelioma in adults whose disease is unresectable or who otherwise are not candidates for potentially curative surgery (designated an orphan drug by FDA for this indication).^{1 3 5 6}

Non-small Cell Lung Cancer

Monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer in adults who have received prior chemotherapy.^{1 4} Efficacy based on surrogate end points of tumor response rate; improvement in disease-related symptoms or increased survival not demonstrated in clinical studies.¹

Alimta Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastics.

  
  

Premedication

• 
  

  Consider pretreatment with a corticosteroid to reduce the incidence and severity of cutaneous reactions.¹ Oral dexamethasone 4 mg twice daily for 3 days, starting 1 day before pemetrexed, used in clinical studies.¹ (See Dermatologic Effects under Cautions.)

  
  

Vitamin Supplementation

• 
  

  To reduce toxicity, all patients should take low-dose oral folic acid (0.4 mg daily) or a multivitamin preparation containing folic acid for at least 5 daily doses during the 7-day period before the first dose of pemetrexed; continue folic acid during therapy and for 21 days after the last dose of pemetrexed.¹

  
  


• 
  

  Administer one IM injection of vitamin B₁₂ during the week before the first dose of pemetrexed and then once every 3 cycles; subsequent injections may be given the same day as pemetrexed.^{1 3} IM vitamin B₁₂ 1 mg used in clinical studies.¹ (See Folate and Vitamin B₁₂ Supplementation under Cautions.)

  
  

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion.¹

Prepare and handle cautiously; use protective gloves.¹ If skin contact occurs, immediately wash affected area(s) thoroughly with soap and water.¹ If mucosa contact occurs, immediately flush thoroughly with water.¹

Not a vesicant.¹ Manage extravasation according to local practice standards.¹

Reconstitution

Reconstitute vial containing 500 mg of pemetrexed with 20 mL of 0.9% sodium chloride injection (without preservatives) to provide a solution containing 25 mg/mL.¹

Gently swirl vial until powder is completely dissolved.¹ Must be diluted further before IV administration.¹

Dilution

Following reconstitution, add the appropriate volume to 100 mL of 0.9% sodium chloride injection (without preservatives).¹

Rate of Administration

Administer by IV infusion over 10 minutes.¹

Dosage

Available as pemetrexed disodium heptahydrate; dosage expressed in terms of anhydrous pemetrexed.¹

Adults

Malignant Pleural Mesothelioma

IV

500 mg/m² on day 1 of a 21-day cycle.¹ Used in conjunction with cisplatin 75 mg/m² on day 1 of a 21-day cycle; initiate cisplatin infusion 30 minutes after completion of pemetrexed infusion.¹

Consult published protocols for information on administration of cisplatin.¹

Adjust subsequent dosages of pemetrexed and cisplatin based on nadir blood counts (i.e., ANCs, platelet counts) and maximum nonhematologic toxicity from preceding dose.¹ (See Dose Modification for Toxicity under Dosage and Administration.)

Do not administer repeat course until ANCs ≥1500/mm³, platelet count ≥100,000/mm³, and Cl_cr ≥45 mL/minute.¹

Non-small Cell Lung Cancer

IV

500 mg/m² on day 1 of a 21-day cycle.¹

Adjust subsequent dosages based on nadir blood counts (i.e., ANCs, platelet counts) and maximum nonhematologic toxicity from preceding dose.¹ (See Dose Modification for Toxicity under Dosage and Administration.)

Do not administer repeat course until ANCs ≥1500/mm³, platelet count ≥100,000/mm³, and Cl_cr ≥45 mL/minute.¹

Dosage Modification for Toxicity

Delay treatment to allow time for recovery from toxicity.¹

Hematologic Toxicity

Reduce dose according to nadir ANC and platelet count.¹ (See Table 1.)

Discontinue therapy if patient experiences grade 3 or 4 hematologic toxicity after 2 dose reductions.¹

Table 1. Recommended Dosage Modification for Hematologic Toxicity of Pemetrexed Monotherapy or Pemetrexed and Cisplatin Combination Therapy

Toxicity	Dose of Pemetrexed	Dose of Cisplatin
Nadir ANC <500/mm3 and nadir platelets ≥50,000/mm3	75% of previous dose	75% of previous dose
Nadir platelets <50,000/mm3, regardless of nadir ANC	50% of previous dose	50% of previous dose

Nonhematologic Toxicity (Except Neurotoxicity)

Reduce dose based on toxicity type and severity. (See Table 2.)¹

Interrupt therapy for grade 3 (except grade 3 elevation in serum transaminase values) or 4 nonhematologic toxicity until resolution to at least pretreatment values.¹

Dosage modification not required for grade 3 elevation in serum transaminase values.^{1 7}

Discontinue if patient experiences grade 3 or 4 nonhematologic toxicity (except grade 3 elevation in serum transaminase values) after 2 dose reductions.¹

Table 2. Recommended Dosage Modification for Nonhematologic Toxicity (Except Neurotoxicity) of Pemetrexed Monotherapy or Pemetrexed and Cisplatin Combination Therapy

Toxicity and National Cancer Institute (NCI) Common Toxicity Criteria Grade	Dose of Pemetrexed	Dose of Cisplatin
Any grade 3 or 4 nonhematologic toxicity (except neurotoxicity), excluding grade 3 or 4 mucositis or grade 3 elevation in serum transaminase values	75% of previous dose	75% of previous dose
Any diarrhea requiring hospitalization (regardless of grade) or grade 3 or 4 diarrhea	75% of previous dose	75% of previous dose
Grade 3 or 4 mucositis	50% of previous dose	100% of previous dose

Neurotoxicity

Reduce cisplatin dose for grade 2 neurotoxicity; no change in pemetrexed dose needed.¹ (See Table 3.)

Discontinue immediately for grade 3 or 4 neurotoxicity.¹

Table 3. Recommended Dosage Modifications for Neurotoxicity of Pemetrexed Monotherapy or Pemetrexed and Cisplatin Combination Therapy

NCI Common Toxicity Criteria Grade	Dose of Pemetrexed	Dose of Cisplatin
0–1	100% of previous dose	100% of previous dose
2	100% of previous dose	50% of previous dose

Special Populations

Renal Impairment

Cl_cr≥45 mL/minute: Routine dosage adjustment not required.¹

Cl_cr<45 mL/minute: Insufficient information to make dosage recommendation; use not recommended.¹ (See Renal Impairment under Cautions.)

Geriatric Patients

No dosage adjustments except those recommended for all patients.¹

Cautions for Alimta

Contraindications

• 
  

  Known hypersensitivity to pemetrexed or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Hematologic Toxicity

Dose-limiting bone marrow suppression (neutropenia, thrombocytopenia, and/or anemia).¹ ANC nadir at day 8–10, with return to baseline 4–8 days after nadir.¹

Folate and Vitamin B₁₂ Supplementation

Folic acid and vitamin B₁₂ needed to prevent treatment-related hematologic and GI toxicity.¹ Use of these supplements associated with overall reduction in toxicity and reduction in grade 3/4 hematologic and nonhematologic toxicities (i.e., neutropenia, febrile neutropenia, infection with grade 3/4 neutropenia).¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.¹ Avoid pregnancy during therapy.¹ If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.¹

Sensitivity Reactions

Dermatologic Effects

Rash reported.¹ Premedicate patients with corticosteroids to reduce incidence and severity of cutaneous reactions.¹

General Precautions

Adequate Patient Evaluation and Monitoring

Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹

Prior to and during therapy, assess CBC and platelet counts.¹ Monitor renal and hepatic function periodically.¹

Other Considerations

Not known whether pemetrexed accumulates in fluid collections such as pleural effusions or ascites; such accumulations could increase toxicity.^{1 5} Some clinicians suggest large effusions be drained before therapy.⁵

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether premetrexed is distributed into milk.¹ Discontinue nursing prior to therapy because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy not established.¹

Hepatic Impairment

Patients with hepatic impairment excluded from clinical trials except those with liver metastases and transaminase concentrations 3–5 times the ULN.¹

Dosage adjustment based on hepatic impairment (i.e., grade 4 elevations in serum transaminase values) experienced during therapy required.¹ (See Nonhematologic Toxicity (except Neurotoxicity) under Dosage and Administration.)

Renal Impairment

Clearance may be decreased; dosage adjustment not needed in patients with Cl_cr≥45 mL/minute.¹

Use not recommended in patients with Cl_cr<45 mL/minute.¹

Withhold repeat cycles until Cl_cr≥45 mL/minute.¹

Use of pemetrexed with cisplatin not evaluated in patients with moderate renal impairment.¹

Caution advised if NSAIAs used in pemetrexed-treated patients with renal impairment.¹ (See Specific Drugs under Interactions.)

Common Adverse Effects

Hematologic effects, fever and infection, stomatitis/pharyngitis, rash/desquamation, nausea, fatigue, dyspnea, vomiting, constipation, chest pain, anorexia.^{1 7}

Interactions for Alimta

Drugs Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interaction unlikely with drugs metabolized by CYP1A2, 2C9, 2D6, or 3A.¹

Nephrotoxic Drugs

Possible delayed clearance of pemetrexed.¹

Specific Drugs

Drug	Interaction	Comments
Cisplatin	Pharmacokinetic interaction unlikely1
NSAIAs	Aspirin (325 mg every 6 hours) does not affect pemetrexed pharmacokinetics; effect of higher aspirin dosage not known1 Ibuprofen may increase pemetrexed AUC1 Effect of NSAIAs with longer half-life on pemetrexed pharmacokinetics not evaluated1	Caution if used concomitantly with ibuprofen in patients with mild to moderate renal impairment (Clcr 45–79 mL/minute)1 Patients with mild to moderate renal impairment should not take NSAIAs with short half-lives for 2 days before, the day of, and for 2 days after pemetrexed administration1 3 7 Patients with mild to moderate renal impairment should not take NSAIAs with longer half-lives for 5 days before, the day of, and for 2 days after pemetrexed administration1 Monitor for toxicity (e.g., myelosuppression and renal and GI toxicity) if concomitant use is necessary1
Probenecid	Possible delayed clearance of pemetrexed1	Similar interaction possible with other substances secreted at the renal tubule1
Vitamins	Decreased pemetrexed toxicity with concomitant oral folic acid and vitamin B121 Pharmacokinetic interaction unlikely with oral folic acid or vitamin B121

Alimta Pharmacokinetics

Absorption

Special Populations

In patients with renal impairment (Cl_cr 45–80 mL/minute), increased AUC.¹

Distribution

Plasma Protein Binding

81%.¹

Special Populations

Degree of renal impairment does not affect protein binding.¹

Elimination

Metabolism

Not metabolized to an appreciable extent.¹

Elimination Route

Principally eliminated in urine as unchanged drug.¹

Half-life

3.5 hours.¹

Special Populations

Clearance of pemetrexed decreases as renal function decreases.¹

Age-related differences in pharmacokinetics not observed in adults 26–80 years of age.¹

Stability

Storage

Parenteral

Powder for Injection

25°C (may be exposed to 15–30°C).¹

Store reconstituted solution and infusion solutions at 25°C (may be exposed to 15–30°C) or refrigerate at 2–8°C; use solution within 24 hours of reconstitution; discard unused solution.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Use 0.9% sodium chloride injection (without preservatives) to reconstitute and dilute pemetrexed.¹

Pemetrexed is not compatible with diluents containing calcium (e.g., Ringer’s injection; Ringer’s injection, lactated).¹

Manufacturer recommends that pemetrexed not be administered with other drugs or diluents other than 0.9% sodium chloride injection.¹

ActionsActions

• 
  

  Disrupts folate-dependent metabolic processes that are essential for cell replication.^{1 3}

  
  


• 
  

  Inhibits the in vitro growth of mesothelioma cell lines (MSTO-211H, NCI-H2052).¹ Synergistic inhibitory effects with cisplatin in the MSTO-211H mesothelioma cell line.¹

  
  

Advice to Patients

• 
  

  Importance of taking folic acid and vitamin B₁₂ to reduce the risk of adverse effects.^{1 2} Importance of taking a corticosteroid for 3 days during each treatment cycle to reduce the risk of a skin reaction.^{1 2}

  
  


• 
  

  Importance of recognizing and reporting adverse effects of pemetrexed, including myelosuppressive effects, infectious complications, and GI symptoms (i.e., diarrhea, mucositis).^{1 2} Necessity of monitoring blood cell counts and serum creatinine.^{1 2} Necessity of dosage adjustment or delay in treatment if toxicity occurs.^{1 2}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Apprise patient of potential hazard to the fetus if used during pregnancy; women of childbearing potential should avoid becoming pregnant.^{1 2}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., NSAIAs) as well as concomitant illnesses.^{1 2}

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pemetrexed Disodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion only	500 mg (of pemetrexed)	Alimta	Lilly

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Alimta 500MG Solution (LILLY): 1/$2932.99 or 3/$8024.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Eli Lilly and Company. Alimta (pemetrexed) for injection prescribing information. Indianapolis, IN; 2004 Aug 19.

2. Eli Lilly and Company. Information for patients and caregivers: Alimta (pemetrexed for injection). Indianapolis, IN; 2004 Aug 19.

3. Vogelzang NJ, Rusthoven JJ, Symanowski J et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003; 21:2636-44. [IDIS 503150] [PubMed 12860938]

4. Hanna N, Shepherd FA, Fossella FV et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004; 22:1589-97. [IDIS 518149] [PubMed 15117980]

5. Anon. Pemetrexed (Alimta) for mesothelioma. Med Lett Drugs Ther. 2004; 46:31-2. [PubMed 15079145]

6. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD; From FDA website (); accessed 2004 Sep 7.

7. Eli Lilly and Company, Indianapolis, IN: Personal communication.

More Alimta resources

• Alimta Side Effects (in more detail)
• Alimta Use in Pregnancy & Breastfeeding
• Alimta Drug Interactions
• Alimta Support Group
• 0 Reviews for Alimta - Add your own review/rating

• Alimta Prescribing Information (FDA)


• Alimta Consumer Overview


• Alimta Advanced Consumer (Micromedex) - Includes Dosage Information


• Alimta MedFacts Consumer Leaflet (Wolters Kluwer)


• Pemetrexed Professional Patient Advice (Wolters Kluwer)

Compare Alimta with other medications

• Malignant Pleural Mesothelioma
• Non-Small Cell Lung Cancer

aliskiren, amlodipine, and hydrochlorothiazide

Generic Name: aliskiren, amlodipine, and hydrochlorothiazide (AL is KYE ren, am LOE de peen, HYE droe klor oh THYE a zide)

Brand Names: Amturnide

What is aliskiren, amlodipine, and hydrochlorothiazide?

Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

The combination of aliskiren, amlodipine, and hydrochlorothiazide is used to treat high blood pressure (hypertension).

Aliskiren, amlodipine, and hydrochlorothiazide is usually given after other blood pressure medications have been tried without successful treatment of symptoms.

Aliskiren, amlodipine, and hydrochlorothiazide may also be used for purposes not listed in this medication guide.

What is the most important information I should know about aliskiren, amlodipine, and hydrochlorothiazide?

Do not use this medication if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. You should not take this medication if you are allergic to aliskiren (Tekturna, Tekamlo), amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tribenzor, Twynsta), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic, and many others), or sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others). You should not take aliskiren, amlodipine, and hydrochlorothiazide if you have severe kidney disease or are unable to urinate, or if you are also taking itraconazole (Sporanox) or cyclosporine (Gengraf, Neoral, Sandimmune).

Before you take aliskiren, amlodipine, and hydrochlorothiazide, tell your doctor if you have kidney or liver disease, glaucoma, lupus, asthma, congestive heart failure, angina (chest pain), coronary artery disease, an electrolyte imbalance (such as low potassium or magnesium), a penicillin allergy, if you are on a low-salt diet, or if you have ever had an allergic reaction to a blood pressure medication.

Your chest pain may become worse when you first start taking the medicine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What should I discuss with my healthcare provider before taking aliskiren, amlodipine, and hydrochlorothiazide?

You should not take this medication if you are allergic to aliskiren (Tekturna, Tekamlo), amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tribenzor, Twynsta), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic, and many others), or sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others). You should not take aliskiren, amlodipine, and hydrochlorothiazide if you have severe kidney disease or are unable to urinate, or if you are also taking itraconazole (Sporanox) or cyclosporine (Gengraf, Neoral, Sandimmune).

To make sure you can safely take aliskiren, amlodipine, and hydrochlorothiazide, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  liver disease;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  angina (chest pain);

  
  


• 
  

  glaucoma;

  
  


• 
  

  systemic lupus erythematosus (SLE);

  
  


• 
  

  asthma;

  
  


• 
  

  coronary artery disease (hardened arteries);

  
  


• 
  

  an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  
  


• 
  

  if you are allergic to penicillin;

  
  


• 
  

  if you are on a low-salt diet; or

  
  


• 
  

  if you have ever had an allergic reaction to a blood pressure medication.

  
  

FDA pregnancy category D. Do not use aliskiren, amlodipine, and hydrochlorothiazide if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. This medication can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking aliskiren, amlodipine, and hydrochlorothiazide. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking aliskiren, amlodipine, and hydrochlorothiazide.

How should I take aliskiren, amlodipine, and hydrochlorothiazide?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Your chest pain may become worse when you first start taking the medicine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Aliskiren, amlodipine, and hydrochlorothiazide may be taken with or without food, but take it the same way each time.

While using aliskiren, amlodipine, and hydrochlorothiazide, you may need blood tests at your doctor's office. Your blood pressure will need to be checked often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using aliskiren, amlodipine, and hydrochlorothiazide.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking aliskiren, amlodipine, and hydrochlorothiazide. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store in the original container at room temperature, away from moisture and heat.

See also: Aliskiren, amlodipine, and hydrochlorothiazide dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include rapid heartbeats, severe dizziness, warmth or tingly feeling, and fainting.

What should I avoid while taking aliskiren, amlodipine, and hydrochlorothiazide?

Do not use potassium supplements or salt substitutes while you are taking aliskiren, amlodipine, and hydrochlorothiazide, unless your doctor has told you to. Drinking alcohol can further lower your blood pressure and may increase certain side effects of aliskiren, amlodipine, and hydrochlorothiazide.

Avoid taking with foods that are high in fat, which can make it harder for your body to absorb aliskiren, amlodipine, and hydrochlorothiazide.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Aliskiren, amlodipine, and hydrochlorothiazide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using aliskiren, amlodipine, and hydrochlorothiazide and call your doctor at once if you have a serious side effect such as:

• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  vision problems, eye pain, or seeing halos around lights;

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  
  


• 
  

  high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness; or

  
  


• 
  

  stuffy nose, sore throat.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aliskiren, amlodipine, and hydrochlorothiazide Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 1 tablet orally daily. The dosage may be increased after 2 weeks of therapy.

Maximum dose: Aliskiren/amlodipine/hydrochlorothiazide 300/10/25 mg orally daily.

Usual Geriatric Dose for Hypertension:

Patients greater than or equal to 75 years of age should start amlodipine at 2.5 mg, which is not available with aliskiren/amlodipine/hydrochlorothiazide.

What other drugs will affect aliskiren, amlodipine, and hydrochlorothiazide?

Tell your doctor about all other heart or blood pressure medications you are taking.

Before using aliskiren, amlodipine, and hydrochlorothiazide, tell your doctor if you regularly use other medicines that can lower blood pressure (such as sedatives, narcotic pain medicine, sleeping pills, and medicine for seizures or anxiety). They can add to the blood pressure lowering effects of aliskiren, amlodipine, and hydrochlorothiazide.

Tell your doctor about all other medicines you use, especially:

• 
  

  atorvastatin (Lipitor, Caduet);

  
  


• 
  

  cholestyramine (Questran) or colestipol (Colestid);

  
  


• 
  

  furosemide (Lasix);

  
  


• 
  

  irbesartan (Avapro);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  simvastatin (Zocor, Simcor, Vytorin, Juvisync);

  
  


• 
  

  tacrolimus (Prograf);

  
  


• 
  

  verapamil (Calan, Covera, Isoptin, Verelan);

  
  


• 
  

  insulin or oral diabetes medication;

  
  


• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  any other diuretic (water pill);

  
  


• 
  

  antifungal medication such as fluconazole (Diflucan), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

  
  


• 
  

  HIV or AIDS medications such as nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or saquinavir (Invirase); or

  
  


• 
  

  non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with aliskiren, amlodipine, and hydrochlorothiazide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More aliskiren, amlodipine, and hydrochlorothiazide resources

• Aliskiren, amlodipine, and hydrochlorothiazide Side Effects (in more detail)
• Aliskiren, amlodipine, and hydrochlorothiazide Dosage
• Aliskiren, amlodipine, and hydrochlorothiazide Use in Pregnancy & Breastfeeding
• Aliskiren, amlodipine, and hydrochlorothiazide Drug Interactions
• Aliskiren, amlodipine, and hydrochlorothiazide Support Group
• 0 Reviews for Aliskiren, amlodipine, and hydrochlorothiazide - Add your own review/rating

Compare aliskiren, amlodipine, and hydrochlorothiazide with other medications

• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about aliskiren, amlodipine, and hydrochlorothiazide.

See also: aliskiren, amlodipine, and hydrochlorothiazide side effects (in more detail)

aliskiren

Generic Name: aliskiren (a LIS ke rin)

Brand Names: Tekturna

What is aliskiren?

Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Aliskiren is used to treat high blood pressure (hypertension).

Aliskiren may also be used for purposes not listed in this medication guide.

What is the most important information I should know about aliskiren?

Do not use this medication if you are pregnant. Aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Stop using this medication and tell your doctor right away if you become pregnant.

Before you take aliskiren, tell your doctor if you have kidney disease, heart disease, if you are on a low-salt diet, or if you have ever had an allergic reaction to a heart or blood pressure medication.

If you take aliskiren with meals, avoid high-fat foods. They can make it harder for your body to absorb aliskiren.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking aliskiren. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

What should I discuss with my health care provider before taking aliskiren?

You should not take aliskiren if you are allergic to it.

To make sure you can safely take aliskiren, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  heart disease;

  
  


• 
  

  if you are on a low-salt diet; or

  
  


• 
  

  if you have ever had an allergic reaction to an ACE (angiotensin converting enzyme) inhibitor medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

  
  

FDA pregnancy category D. Do not use this medication if you are pregnant. Aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Stop using this medication and tell your doctor right away if you become pregnant. It is not known whether aliskiren passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aliskiren?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take aliskiren with a full glass of water.

You may take aliskiren with or without food, but take it the same way every time.

If you take aliskiren with meals, avoid high-fat foods. They can make it harder for your body to absorb aliskiren.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking aliskiren. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store at room temperature away from moisture and heat.

See also: Aliskiren dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include feeling light-headed or fainting.

What should I avoid while taking aliskiren?

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of aliskiren. Do not use salt substitutes or potassium supplements while taking aliskiren, unless your doctor has told you to.

Aliskiren side effects

Stop taking aliskiren and get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

If you have an allergic reaction to aliskiren you should not take it again.

Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling light-headed, fainting;

  
  


• 
  

  nausea with slow uneven heart rate and a weak pulse; or

  
  


• 
  

  swelling around your eyes.

  
  

Less serious side effects may include:

• 
  

  stomach pain or upset, diarrhea, heartburn;

  
  


• 
  

  itching or skin rash;

  
  


• 
  

  headache, dizziness, tired feeling;

  
  


• 
  

  back pain, joint pain or swelling; or

  
  


• 
  

  stuffy nose, sore throat, cough.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aliskiren Dosing Information

Usual Adult Dose for Hypertension:

Initial: 150 mg orally once a day
Maintenance: the dosage may be increased to 300 mg daily if blood pressure is not adequately controlled.

Aliskiren may be used alone or in combination with other antihypertensive agents.

What other drugs will affect aliskiren?

The following drugs can interact with aliskiren. Tell your doctor if you are using any of these:

• 
  

  atorvastatin (Lipitor);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  furosemide (Lasix);

  
  


• 
  

  antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);

  
  


• 
  

  a potassium supplement such as K-Dur, Klor-Con;

  
  


• 
  

  salt substitutes that contain potassium; or

  
  


• 
  

  a diuretic (water pill).

  
  

This list is not complete and other drugs may interact with aliskiren. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More aliskiren resources

• Aliskiren Side Effects (in more detail)
• Aliskiren Dosage
• Aliskiren Use in Pregnancy & Breastfeeding
• Aliskiren Drug Interactions
• Aliskiren Support Group
• 23 Reviews for Aliskiren - Add your own review/rating

• aliskiren Advanced Consumer (Micromedex) - Includes Dosage Information


• Aliskiren Professional Patient Advice (Wolters Kluwer)


• Aliskiren MedFacts Consumer Leaflet (Wolters Kluwer)


• Aliskiren Hemifumarate Monograph (AHFS DI)


• Tekturna Prescribing Information (FDA)


• Tekturna Consumer Overview

Compare aliskiren with other medications

• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about aliskiren.

See also: aliskiren side effects (in more detail)

Alka-Mints

Generic Name: calcium carbonate (KAL see um KAR boe nate)

Brand Names: Alka-Mints, Cal-Gest, Calcarb, Calci Mix, Calci-Chew, Calci-Mix, Calcium Concentrate, Calcium Liquid Softgel, Calcium Oyster Shell, Caltrate, Chooz, Extra Strength Mylanta Calci Tabs, Icar Prenatal Chewable Calcium, Maalox Antacid Barrier, Maalox Childrens', Maalox Quick Dissolve, Maalox Quick Dissolve Maximum Strength, Maalox Regular Strength, Mylanta Child, Nephro Calci, Os-Cal 500, Oysco 500, Oyst Cal 500, Oyster Cal, Oyster Calcium, Oyster Shell, Pepto Children's, Rolaids Sodium Free, Rolaids Soft Chew, Titralac, Tums, Tums 500, Tums E-X, Tums Kids, Tums QuikPak, Tums Ultra

What is Alka-Mints (calcium carbonate)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of the body, especially bone formation and maintenance. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Calcium carbonate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Alka-Mints (calcium carbonate)?

Do not take calcium carbonate or antacids that contain calcium without first asking your doctor if you also take other medicines. Calcium can make it harder for your body to absorb certain medicines. Calcium carbonate works best if you take it with food.

What should I discuss with my healthcare provider before taking Alka-Mints (calcium carbonate)?

To make sure you can safely take calcium carbonate, tell your doctor if you have any of these other conditions:

• 
  

  a history of kidney stones; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium carbonate if you are pregnant. Talk to your doctor before taking calcium carbonate if you are breast-feeding a baby.

How should I take Alka-Mints (calcium carbonate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Calcium carbonate works best if you take it with food. Swallow the calcium carbonate tablet or capsule with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Use the calcium carbonate powder as directed. Allow the powder to dissolve completely, then consume the mixture.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, decreased appetite, constipation, confusion, delirium, stupor, and coma.

What should I avoid while taking Alka-Mints (calcium carbonate)?

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

Alka-Mints (calcium carbonate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  decreased appetite;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth or increased thirst; or

  
  


• 
  

  urinating more than usual.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs can affect Alka-Mints (calcium carbonate)?

Calcium carbonate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids or other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or vitamin D supplements; or

  
  


• 
  

  doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with calcium carbonate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Alka-Mints resources

• Alka-Mints Side Effects (in more detail)
• Alka-Mints Use in Pregnancy & Breastfeeding
• Alka-Mints Drug Interactions
• Alka-Mints Support Group
• 0 Reviews for Alka-Mints - Add your own review/rating

• Calcium Carbonate MedFacts Consumer Leaflet (Wolters Kluwer)


• Titralac Consumer Overview


• Titralac MedFacts Consumer Leaflet (Wolters Kluwer)


• Tums Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Alka-Mints with other medications

• Duodenal Ulcer
• Erosive Esophagitis
• GERD
• Indigestion
• Stomach Ulcer

Where can I get more information?

• Your doctor or pharmacist can provide more information about calcium carbonate.

See also: Alka-Mints side effects (in more detail)

Alka-Seltzer Plus Cold and Cough

Generic Name: aspirin/chlorpheniramine/dextromethorphan/ phenylpropanolamine (AS pir in/klor fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)

Brand Names: Alka Seltzer Plus Cold and Cough

What is aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Aspirin is in a class of drugs called salicylates. Aspirin is a pain reliever, an anti-inflammatory, and a fever reducer. It is used to treat many conditions, such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Chlorpheniramine is an antihistamine. It blocks the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces blood flow to affected areas and allows nasal passages to open up.

The combination, aspirin/chlorpheniramine/ dextromethorphan/phenylpropanolamine is used to treat nasal congestion; sinusitis (inflammation of the sinuses); headache; fever; and aches, pains, and coughs associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine. Alcohol can also be damaging to the stomach when it is taken with aspirin.

Do not take more of this medication than is recommended. If your symptoms do not improve or if they worsen, see your doctor.

Who should not take aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day. Combined with alcohol, aspirin can be damaging to the stomach.

Do not take aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  an ulcer,

  
  


• 
  

  a bleeding or blood clotting disorder,

  
  


• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

You may not be able to take aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine will harm an unborn baby. Do not take aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine without first talking to your doctor if you are pregnant. This medication passes into breast milk and can harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine. You may require a lower dose of this medication. Do not use any medication that contains aspirin to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.

How should I take aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Take aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take this medication with food or milk if stomach upset occurs. Do not take more of this medication than is recommended.

Do not take aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, see your doctor.

Do not take any aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine that smells strongly of vinegar. This smell means that the aspirin has begun to break down.

Store aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, ringing in the ears, dizziness, hallucinations, seizures, rapid breathing, nausea, and vomiting.

What should I avoid while taking aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine. Also, alcohol can also be damaging to the stomach when it is taken with aspirin.

Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.

Avoid prolonged exposure to sunlight. Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the sensitivity of the skin to sunlight. Use a sun screen and wear protective clothing when sun exposure is unavoidable.

Be aware of the aspirin content of other over-the-counter and prescription products. Any aspirin content in these products counts toward your total daily dose.

Aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine side effects

If you experience any of the following serious side effects, stop taking aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine and seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  blood in vomit or urine;

  
  


• 
  

  nausea, vomiting, or abdominal pain;

  
  


• 
  

  uncontrolled fever;

  
  


• 
  

  seizures;

  
  


• 
  

  an irregular heartbeat; or

  
  


• 
  

  abnormal behavior, hallucinations, or paranoia.

  
  

Other, less serious side effects may be more likely to occur. Continue to take aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine and talk to your doctor, or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness, lightheadedness, dizziness, or weakness;

  
  


• 
  

  headache;

  
  


• 
  

  faint ringing in the ears;

  
  


• 
  

  upset stomach or indigestion;

  
  


• 
  

  blurred vision;

  
  


• 
  

  restlessness, tremor, insomnia, or anxiety;

  
  


• 
  

  sweating;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Do not take aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, pain, fever, or sleep medicines while taking aspirin/chlorpheniramine/dextromethorphan/ phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain aspirin, chlorpheniramine, phenylpropanolamine, or other similar drugs, and you may accidentally take too much and harm yourself.

Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Alka Seltzer Plus Cold and Cough resources

• Alka Seltzer Plus Cold and Cough Drug Interactions
• Alka Seltzer Plus Cold and Cough Support Group
• 0 Reviews · Be the first to review/rate this drug

Where can I get more information?

• Your pharmacist has additional information about aspirin/chlorpheniramine/ dextromethorphan/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine is available over the counter under the brand name Alka-Seltzer Plus Cough and Cold Tablets. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Alka-Seltzer Plus Cold/Cough

Pronunciation: a-seet-a-MIN-oh-fen/klor-fen-EER-a-meen/dex-troe-meth-OR-fan/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine
Brand Name: Examples include Alka-Seltzer Plus Cold/Cough and Tylenol Cold

Alka-Seltzer Plus Cold/Cough is used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Alka-Seltzer Plus Cold/Cough is a decongestant, antihistamine, cough suppressant and analgesic combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce a dry or unproductive cough.

Do NOT use Alka-Seltzer Plus Cold/Cough if:

• you are allergic to any ingredient in Alka-Seltzer Plus Cold/Cough


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alka-Seltzer Plus Cold/Cough:

Some medical conditions may interact with Alka-Seltzer Plus Cold/Cough. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; overactive thyroid; or liver problems; or if you consume more than 3 alcohol-containing drinks per day


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Alka-Seltzer Plus Cold/Cough. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Alka-Seltzer Plus Cold/Cough may be increased


• Anticoagulants (eg, warfarin), digoxin or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Alka-Seltzer Plus Cold/Cough


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Alka-Seltzer Plus Cold/Cough

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alka-Seltzer Plus Cold/Cough may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alka-Seltzer Plus Cold/Cough:

Use Alka-Seltzer Plus Cold/Cough as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alka-Seltzer Plus Cold/Cough may be taken with or without food.


• If you miss a dose of Alka-Seltzer Plus Cold/Cough, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Alka-Seltzer Plus Cold/Cough.

Important safety information:

• Alka-Seltzer Plus Cold/Cough may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alka-Seltzer Plus Cold/Cough. Using Alka-Seltzer Plus Cold/Cough alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Alka-Seltzer Plus Cold/Cough without checking with you doctor.


• Alka-Seltzer Plus Cold/Cough contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Alka-Seltzer Plus Cold/Cough for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Alka-Seltzer Plus Cold/Cough may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Alka-Seltzer Plus Cold/Cough. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• Alka-Seltzer Plus Cold/Cough may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Alka-Seltzer Plus Cold/Cough or other pain relievers/fever reducers. Alcohol use combined with Alka-Seltzer Plus Cold/Cough may increase your risk for liver damage.


• If you are scheduled for allergy skin testing, do not take Alka-Seltzer Plus Cold/Cough for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Alka-Seltzer Plus Cold/Cough.


• Use Alka-Seltzer Plus Cold/Cough with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Alka-Seltzer Plus Cold/Cough in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Alka-Seltzer Plus Cold/Cough, discuss with your doctor the benefits and risks of using Alka-Seltzer Plus Cold/Cough during pregnancy. It is unknown if Alka-Seltzer Plus Cold/Cough is excreted in breast milk. Do not breast-feed while taking Alka-Seltzer Plus Cold/Cough.

Possible side effects of Alka-Seltzer Plus Cold/Cough:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Alka-Seltzer Plus Cold/Cough side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Alka-Seltzer Plus Cold/Cough:

Store Alka-Seltzer Plus Cold/Cough at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alka-Seltzer Plus Cold/Cough out of the reach of children and away from pets.

General information:

• If you have any questions about Alka-Seltzer Plus Cold/Cough, please talk with your doctor, pharmacist, or other health care provider.


• Alka-Seltzer Plus Cold/Cough is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Alka-Seltzer Plus Cold/Cough. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Alka-Seltzer Plus Cold/Cough resources

• Alka-Seltzer Plus Cold/Cough Side Effects (in more detail)
• Alka-Seltzer Plus Cold/Cough Use in Pregnancy & Breastfeeding
• Alka-Seltzer Plus Cold/Cough Drug Interactions
• Alka-Seltzer Plus Cold/Cough Support Group
• 1 Review for Alka-Seltzer Plus Cold/Cough - Add your own review/rating

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