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Drug Facts
Manufactured by:
VKT Pharma Private Limited
Srikakulam, India-532 409,
M.L. No.: 02/SKL/AP/2015/F/R
Repackaged by:
Neeyaan LLC,
4 Corporate Dr,
Cranbury NJ 08512
Revision: 05/2024
Famotidine Tablet, Film Coated
FDA Label NDC 71821-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vkt Pharma Private Limited for the product Famotidine (NDC 71821-012). 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 other, active ingredient (in each tablet), purpose, uses, allergy alert, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Famotidine USP, 10 mg and 20 mg
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, 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
Otc - Ask Doctor/Pharmacist
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 (of 10 mg) with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
- to prevent symptoms, swallow 1 tablet (of 20 mg) 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° - 77°F)
- protect from moisture
- compares to the active ingredient in Zantac 360
Inactive Ingredients
Microcrystalline Cellulose, Pre-gelatinized Starch, Sodium Starch glycolate, Hydroxypropyl Cellulose, Magnesium stearate, Hypromellose, Titanium dioxide, Triacetin, Talc, Macrogol
Questions Or Comments?
1 844-387-1231 (toll-free)
Package Label-Principal Display Panel
Famotidine Tablets, USP 10 mg NDC 71821-012-09 Bulk Label
Image Description (Famotidine Tabs 10mg Label)
Famotidine Tablets, USP 20 mg NDC 71821-010-13 Bulk Label
Image Description (Famotidine Tabs 20mg Label)
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