Drugplain

Pepcid Complete 800 mg/1

Famotidine, Calcium carbonate, and Magnesium hydroxide · TABLET, CHEWABLE · Kenvue Brands LLC

No Recall History
Plain English

Pepcid Complete is a tablet, chewable containing famotidine, calcium carbonate, and magnesium hydroxide at 800 mg/1, taken oral. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
Pepcid Complete
Generic Name
Famotidine, Calcium carbonate, and Magnesium hydroxide
NDC Code (Product)
16837-298
Manufacturer
Kenvue Brands LLC
Strength
800 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
NDA020958
Drug Class
Histamine-2 Receptor Antagonist [EPC]
Marketing Start
03/01/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease483 reports
drug ineffective306 reports
acute kidney injury256 reports
renal failure174 reports
end stage renal disease133 reports
gastrooesophageal reflux disease133 reports
product use in unapproved indication98 reports
off label use97 reports
incorrect dose administered95 reports
wrong technique in product usage process94 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use relieves heartburn associated with acid indigestion and sour stomach

Dosage & Administration

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

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)

Frequently Asked Questions

What is Pepcid Complete used for?

Pepcid Complete contains Famotidine, Calcium carbonate, and Magnesium hydroxide. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is Pepcid Complete a controlled substance?

Pepcid Complete is not classified as a controlled substance by the DEA.

What is the generic name for Pepcid Complete?

The generic name for Pepcid Complete is Famotidine, Calcium carbonate, and Magnesium hydroxide. There are 1 other brand versions of Famotidine, Calcium carbonate, and Magnesium hydroxide.

What is the NDC code for Pepcid Complete 800 mg/1?

The NDC (National Drug Code) for Pepcid Complete 800 mg/1 is 16837-298, listed by Kenvue Brands LLC.

Product NDC

16837-298

Package NDC

16837-298-12

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)