TAGAMET

CIMETIDINE ORAL HUMAN OTC DRUG

TAGAMET is an FDA drug label for the active ingredient CIMETIDINE manufactured by Prestige Brands Holdings, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230120.

Generic name
CIMETIDINE
Manufacturer
Prestige Brands Holdings, Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
52183-223
Application
NDA020238
Label effective
20230120

Active ingredients

Active ingredient (in each tablet) Cimetidine 200mg

Indications & Usage

Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Dosage & Administration

Directions adults and children 12 years and older: ▪ to relieve symptoms, swallow 1 tablet with a glass of water ▪ to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30 minutes before eating food or drinking beverages that cause heartburn ▪ do not take more than 2 tablets in 24 hours children under 12 years: ask a doctor

Contraindications

Not available.

Warnings

Warnings Allergy a lert: Do not use if you are allergic to cimetidine 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 frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain 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 kidney disease liver disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if you need to take this product for more than 14 days stomach pain continues your heartburn continues or worsens 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 (1-800-222-1222) right away.

Adverse Reactions

Not available.

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