Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameFAMOTIDINE
Labeler / manufacturerAurohealth LLC
RouteORAL
Drug classHistamine-2 Receptor Antagonist
Product NDC58602-829
Label effective date2026-09-04
Official product label reference
Famotidine — Aurohealth LLC
This page contains 15 source sections for FAMOTIDINE, oral route. Label set 5b161f25-c578-4ff4-a931-ff3a1e681c50, version 10.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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
Purpose
Purpose Acid reducer
Dosage and administration — label text
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
Warnings
Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Unclassified section
Drug Facts
Active ingredient
Active ingredient (in each tablet) Famotidine USP 20 mg
Do not use
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
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
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
When to stop use and seek help
Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
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.
Storage and handling
Other information read the directions and warnings before use keep the carton. It contains important information. store at 20° to 25°C (68° to 77°F) protect from moisture
Inactive ingredient
Inactive ingredients carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.
Questions
Questions or comments? call 1-855-274-4122 Tips for Managing Heartburn Do not lie flat or bend over after eating Do not wear tight-fitting clothing around the stomach Do not eat before bedtime Raise the head of your bed Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables Eat slowly and avoid big meals If overweight, lose weight Quit smoking JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. Do not use if carton is open or if printed foil seal under bottle cap is open or torn. Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.