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 |
|---|---|---|---|---|---|
| 02185938 | PEPCID AC | FAMOTIDINE | 10 MG | TABLET | ORAL |
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
Side effects and what to do about them
PEPCID AC® is generally well tolerated.
| 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