Details for: MAXIMUM STRENGTH PEPCID AC
Company: MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02273357 | MAXIMUM STRENGTH PEPCID AC | FAMOTIDINE | 20 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
Each MAXIMUM STRENGTH PEPCID® AC tablet is clinically proven to give fast and effective relief from heartburn, acid indigestion and sour or upset stomach due to excess stomach acid. MAXIMUM STRENGTH PEPCID® AC when taken 10 - 15 minutes before a meal, prevents these symptoms brought on by eating or drinking food and beverages.
What it does
It is normal for the stomach to produce acid, especially after eating food and/or drinking beverages. However, too much acid, can cause, heartburn, acid indigestion and discomfort that interfere with everyday activities. MAXIMUM STRENGTH PEPCID® AC contains a medicine that actually reduces the production of excess stomach acid that causes these symptoms. MAXIMUM STRENGTH PEPCID® AC is different from antacids that only neutralize existing stomach acid, but do not stop stomach acid from being produced. MAXIMUM STRENGTH PEPCID® AC actually stops tough heartburn before it starts. Just one MAXIMUM STRENGTH PEPCID® AC tablet provides long lasting acid control, for up to 12 hours day or night. Acid control may not directly correlate to symptom relief.
When it should not be used
- If you are allergic to famotidine or to any component in the medication (see non-medicinal ingredients);
- If you are allergic to other acid reducers;
- With another acid reducer.
What the medicinal ingredient is
The medicinal ingredient is famotidine.
What the non-medicinal ingredients are
MAXIMUM STRENGTH PEPCID® AC also contains: carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide.
What dosage form it comes in
MAXIMUM STRENGTH PEPCID® AC is available as a 20 mg, film-coated tablet and thus easy-to-swallow.
Warnings and precautions
This medicine may not be suitable for some people. BEFORE you use MAXIMUM STRENGTH PEPCID®AC talk to your doctor or pharmacist if:
- You are pregnant or breast-feeding;
- You have trouble swallowing, pain on swallowing, severe vomiting, passage of red/black blood in the stools, wheezing, choking, or your stomach pains continue;
- 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 erosive esophagitis, irritable bowel syndrome or ulcer disease complications;
- You are experiencing unintended weight loss in association with your symptoms of acid indigestion or heartburn;
- You are taking a proton pump inhibitor;
- Your heartburn is frequent (>3 times per week) and or severe;
- 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.
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 you use MAXIMUM STRENGTH PEPCID® AC talk to your doctor or pharmacist if:
- You are taking 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.
TIPS TO HELP AVOID ACID-RELATED SYMPTOMS
- Do not lie down or bend over soon after eating.
- If you are overweight, lose weight.
- If you smoke, stop or cut down.
- Certain foods are more likely to cause acid-related symptoms, so you should consider reducing or avoiding 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
MAXIMUM STRENGTH PEPCID® AC is generally well tolerated. Side effects such as headache, diarrhea, lung infections, and vomiting were reported in studies where people took either the drug or a placebo (tablet with no medication). Each group had about the same number of side effects.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medic |
|---|---|---|---|
| Very Rare | |||
| Dizziness and sleepiness | ✔ | ||
| Stomach pain, diarrhea, dry mouth, nausea, and vomiting | ✔ | ||
| Allergic reactions such as hives, rash, itching, swelling and difficulty to breath | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MAXIMUM STRENGTH PEPCID® AC, contact your doctor or pharmacist.
How to store
- Store at room temperature (15-30°C) and protect from moisture.
- Keep this and all medicines out of the reach of children.
Reporting side effects
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/healthcanada/services/drugs-health-products/medeffectcanada/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