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Details for: PEPCID COMPLETE

Company: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02243053PEPCID COMPLETEFAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE10 MG; 800 MG; 165 MGTABLET (CHEWABLE)ORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

PEPCID® COMPLETE® begins to work on contact to provide fast, long lasting and effective relief from heartburn, acid indigestion and upset or sour stomach due to excess stomach acid. PEPCID® COMPLETE® also prevents these symptoms brought on by consuming food and/or beverage.

What it does

PEPCID® COMPLETE® contains the active ingredient famotidine (an acid reducer) along with the antacids, calcium carbonate and magnesium hydroxide. This advanced formula combines the benefits of both an antacid and acid reducer in one tablet.

PEPCID® COMPLETE® combines these two types of ingredients because they relieve heartburn in two different ways. The antacid begins by neutralizing acid on contact. The acid reducer keeps working, day or night, to reduce the production of excess stomach acid.

When it should not be used

Do not use Pepcid Complete

  • if you are allergic to Famotidine or any nonmedicinal ingredients (see complete list) in the product.
  • if you have had an allergic reaction to another product that contains an acid reducer (e.g. ranitidine).
  • with other acid reducers.
What the medicinal ingredient is

Each tablet of PEPCID® COMPLETE® contains 10 mg of famotidine, 800 mg of calcium carbonate and 165 mg of magnesium hydroxide. Each tablet provides 320 mg of elemental calcium and 70 mg of elemental magnesium.

What the non-medicinal ingredients are

PEPCID® COMPLETE® chewable tablets also contain the following non-medicinal ingredients: cellulose acetate, crospovidone, dextrose monohydrate, flavours, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, Prosweet® Powder (contains cornstarch), sucralose.

PEPCID® COMPLETE® chewable tablets – mint flavour also contain FD&C Blue #1 and D&C Yellow #10.

What dosage form it comes in

PEPCID® COMPLETE® is available as a chewable tablet.

Warnings and precautions

This medicine may not be suitable for some people. BEFORE you use PEPCID® COMPLETE® talk to your doctor or pharmacist if:

  • You are pregnant or breast-feeding.
  • You have difficulty or pain on swallowing, severe vomiting, black stool, choking, or persistent stomach pains/ discomfort.
  • You have kidney disease as you may need a dosage adjustment
  • You have any other severe illnesses.
  • You are over 40 years of age and you are experiencing new or recently changed symptoms of acid indigestion or heartburn.
  • You are taking any prescription or over-the-counter medications, such as nonsteroidal anti-inflammatory drugs [NSAIDs] (because these medicines may be causing your symptoms).
  • You have a previous history of ulcer disease complications.
  • You are experiencing unintended weight loss in association with your symptoms of acid indigestion or heartburn.
  • You have heartburn over 3 months. This may be a sign of a more serious condition.
  • You have heartburn with light headedness, sweating and dizziness
  • You have chest or shoulder pain with shortness of breath, sweating, pain spreading to arms, neck or shoulders; or light headedness

Stop use and ask a doctor if:

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Interactions with this medication

BEFORE you use PEPCID® COMPLETE® talk to your doctor or pharmacist if:

  • You are taking a prescription drug, iron, calcium carbonate or zinc sulfate as some drug interactions could occur.
  • You are using Itraconazole (for fungal infections).
  • You are using antibiotics or drugs for HIV.

Most interactions can be avoided by taking PEPCID® COMPLETE® 2 hours before or after ingestion of other drugs.

Proper use of this medication

Usual Dose

FOR HEARTBURN OR ACID INDIGESTION: Adults and children 12 years and older: For fast, long lasting and effective relief of symptoms, chew one (1) tablet. If symptoms return, you may chew another tablet. For prevention of acid-related symptoms brought on by consuming food and/or beverage, chew one (1) tablet 1 hour before eating. Maximum 2 tablets in 24 hours.

WHAT ELSE CAN BE DONE TO AVOID SYMPTOMS

  • Do not lie down soon after eating.
  • If you are overweight, lose weight.
  • If you smoke, stop or cut down
  • Avoid or limit foods such as caffeine, chocolate, fatty foods, spicy foods and alcohol
  • Do not eat just before bedtime

Do not take within two hours of another medicine because the effectiveness of the other medicine may be altered.

If symptoms get worse or persist for more than two consecutive weeks, or if new symptoms develop, stop use and consult your doctor.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no
Side effects and what to do about them

PEPCID® COMPLETE® is generally well tolerated.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Very Rare
Dizziness, headache, sleepiness, weakness ✔    
Stomach pain, diarrhea, dry mouth, nausea, vomiting   ✔  
Allergic reactions such as hives, rash, swelling, itching and difficulty to breath   ✔  

For any unexpected effects while taking PEPCID® COMPLETE® contact your doctor or pharmacist.

How to store
  • Store tablets at 15°C - 30°C. Protect from moisture.
  • Keep this and all medicines out of the reach of children.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/ health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, McNeil Consumer Healthcare, division of Johnson and Johnson Inc., at:
1-800-4PEPCID

This leaflet was prepared by McNeil Consumer Healthcare, division of Johnson and Johnson Inc.

Last revised: May 24, 2019

Date modified: