Active Ingredient (In Each Tablet)
Famotidine Tablets USP, 20mg
Famotidine Tablet
FDA Label NDC 21130-191
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Famotidine (NDC 21130-191). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acid Reducer
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 food and beverages
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, vomitiing 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 lighteasdedness, sweating or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chestpain
- 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. 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)
Directions
- adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn.
- do not use more than 2 tablets in 24 hours
- children under 12 years: ask a doctor
Other Information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20-25 C (68-77F)
- protect from moisture
Inactive Ingredients
hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, sodium
starch glycolate, talc, titanium dioxide, triacetin
Questions Or Comments?
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