Famotidine
- Dosage form
- TABLET, FILM COATED
- Labeler
- VKT Pharma Private Limited
- Label updated
- 2024-01-25
- Retrieved
- 2026-09-07
- Active ingredients
- FAMOTIDINE
Label information
Drug Facts
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
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
Label information
Ask a doctor or pharmacist before use if you aretaking 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
Label information
If pregnant or breast-feeding,ask a health professional before use.
Label information
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 relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
- to preventsymptoms, swallow 1 tablet (of 10 mg) with a glass of water at any time from 15 to 60 minutes beforeeating food or drinking beverages that cause heartburn
- to preventsymptoms, swallow 1 tablet (of 20 mg) with a glass of water at any time from 10 to 60 minutes beforeeating 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)
Label information
Manufactured by:
VKT Pharma Private Limited
Srikakulam, India-532 409,
M.L. No.: 02/SKL/AP/2015/F/R
Repackaged by:
Granules USA Inc,
35 Waterview Blvd, 3rd Floor
Parsippany NJ 07054 USA.
Revision: 08/2022
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Famotidine Tablets USP 10mg - NDC 71821-012-08 -Container Label
[Image in the official label — see DailyMed source]
Famotidine Tablets USP 10mg - NDC 71821-012-08 -Pouch Label
[Image in the official label — see DailyMed source]
Famotidine Tablets USP 20mg - NDC 71821-010-12 -Container Label
[Image in the official label — see DailyMed source]
Famotidine Tablets USP 20mg - NDC 71821-010-12 -Pouch Label
[Image in the official label — see DailyMed source]
DailyMed Set ID: 4e5db906-992f-476b-9d97-63a4c582bbdc · Version 4
NDC: 71821-010, 71821-012