Pepcid Complete

Pepcid Complete is an FDA-registered drug product whose active ingredient is FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE. It is labelled by Kenvue Brands LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 16837-891, application NDA020958, label effective 20260724. It is one of 3 FDA drug label records sharing the active ingredient FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE are most often described in connection with: relieves heartburn, acid indigestion, sour stomach. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use relieves heartburn associated with acid indigestion and sour stomach

Directions adults and children 12 years and over: do not swallow tablet whole: chew completely to relieve symptoms, chew 1 tablet before swallowing do not use more than 2 chewable tablets in 24 hours children under 12 years: ask a doctor

Warnings Allergy alert Do not use if you are allergic to famotidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

FDA lists 3 drug label records with FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Pepcid Complete used for?
Use relieves heartburn associated with acid indigestion and sour stomach

Who makes Pepcid Complete?
Kenvue Brands LLC is the labeler of record for Pepcid Complete. 3 FDA label records share the active ingredient FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Pepcid Complete come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Pepcid Complete prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE?
Yes. 3 FDA drug label records list FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Pepcid Complete been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.