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Details for: PEPCID AC

Company: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02185938PEPCID ACFAMOTIDINE10 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

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 AC® Acid Controller provides fast effective relief from heartburn, acid indigestion and upset or sour stomach due to excess stomach acid. In addition, when taken 10-15 minutes before a meal, PEPCID® ACcan actually prevent heartburn before it starts. Day or night, PEPCID AC® relieves and prevents these symptoms brought on by consuming food and/or beverage. One tablet, taken before your evening meal can prevent night-time heartburn symptoms so you can sleep through the night.

What it does

Unlike antacids which neutralize existing stomach acid, but allow stomach acid to continue to be produced, PEPCID AC® reduces the production of excess stomach acid which can lead to heartburn and upset stomach. This enables PEPCID AC® to provide long lasting acid control, day or night.

When it should not be used

When it should not be used:

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

Each film-coated tablet of PEPCID AC® contains 10 mg of famotidine.

What the non-medicinal ingredients are

Film-coated tablets contain the following non-medicinal ingredients: carnauba wax, corn starch, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide.

What dosage form it comes in

PEPCID AC® is available as a film-coated tablet to ease swallowing.

Warnings and precautions

Serious Warnings and Precautions

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

  • You are pregnant or breast-feeding;
  • You have difficulty or pain on swallowing, severe vomiting, black stools, choking, or persistent stomach pains/ discomfort;
  • You have kidney disease, as you may need a dose 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 medicationssuch as nonsteroidal anti-inflammatory drugs [NSAIDs] (because NSAIDs 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 with light headedness, sweating and dizziness;
  • You have chest or shoulder pain with shortness of breath, sweating, pain spreading to arms or neck, or light headedness.

HEARTBURNWARNINGS
Heartburn and acid indigestion are common; however heartburn can be a sign of a more serious medical condition, which requires medical intervention. Stop use of this product and any other nonprescription products you are taking for heartburn and see your doctor or pharmacist if:

  • you have had heartburn for over 3 months and haven’t seen a doctor about it
  • your heartburn continues, worsens or returns after using heartburn medication every day for 14 days.
  • you often need to use heartburn medication for 14 consecutive days (for example every 6 weeks or more frequently).
  • your heartburn continues after using this or any other nonprescription heartburn product.
Interactions with this medication

Before taking PEPCID AC® talk to your doctor or pharmacist if:

  • You are using Itraconazole (for fungal infections).
  • You are using calcium carbonate
Proper use of this medication

Usual Dose

Adults and children 12 years of age or older: For relief of symptoms, swallow one (1) tablet with full glass of water. For prevention of acid-related symptoms brought on by consuming food and/or beverage swallow one (1) tablet with full glass of water 10 to 15 minutes before eating. If symptoms return, you may take another tablet. Do not take more than two tablets during a 24-hour period. If symptoms get worse or persist for more than two consecutive weeks, or if new symptoms develop, stop use and consult your physician.

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 foods known to cause symptoms, and avoid or limit foods such as caffeine, chocolate, fatty foods, spicy foods and alcohol.
  • Do not eat just before bedtime.
  • Raise the head of your bed.
  • Wear loose fitting clothing around your stomach.

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 symptoms.
Side effects and what to do about them

PEPCID AC® 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    

This is not a complete list of side effects. If you have any unexpected effects after taking Pepcid AC® contact your doctor or pharmacist.

How to store
  • Store these tablets at room temperature (15°C-30°C) and protect from moisture.
  • It is advisable to keep blisters in carton until all tablets are used.
  • 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: