Active Ingredient (In Each Tablet)
Famotidine USP, 10 mg
Famotidine
FDA Label NDC 55315-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fred's Inc. for the product Famotidine (NDC 55315-035). 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, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, 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
Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do Not Use
- with other acid reducers
- 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.
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
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 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
- store at 20° to 25°C (68° to 77°F)
- protect from moisture
- read the directions and warnings before use
- keep the carton. It contains important information.
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.
Inactive Ingredients
Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide
Questions?
Call 1-800-406-7984
Patient Information
- 1 tablet relieves heartburn due to acid indigestion
- Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
- 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
Tips for Managing Heartburn
Principal Display Panel
fred's®
Original Strength
Acid Controller
Famotidine Tablets USP, 10 mg
Acid Reducer
Just One Tablet
Prevents & Relieves Heartburn Due to Acid Indigestion
30 TABLETS
Compare To Original Strength Pepcid®AC†
DISTRIBUTED BY: fred's, Inc.
5092839/R0112
This Is The 30 Count Blister Carton Label For Fred's Famotidine Tablets Usp, 10 mg. (Famo10)
* Please review the disclaimer below.
