Active Ingredient(S)
Famotidine USP 20mg
Acid Reducer Tablet
FDA Label NDC 69168-443
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Acid Reducer (NDC 69168-443). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, 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
Use(S)
- 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
- 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 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 Breastfeeding,
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 15 to 60 minutes before eating food or drinking beverages that
cause heartburn n 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
- do not use if imprinted safety seal under cap is broken or missing
- store at 20°-25°C (68°-77°F)
- protect from moisture
Inactive Ingredients
Hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline
cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM − 5PM EST
Principal Display Panel
Acid Reducer Max Strength
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