Famotidine
Famotidine Tablets
de42b6c4-c44b-4ec1-b505-fc5266452d57
HUMAN OTC DRUG LABEL
May 27, 2025
Precision Dose, Inc.
DUNS: 035886746
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FAMOTIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton
PrecisionDose™
NDC 68094-054-65
Unit Dose
Famotidine
Tablets 20 mg
200 Tablets
(20 x 10)
(in each tablet)
Famotidine 20 mg
Acid reducer
Directions
To relieve symptoms, swallow 1 tablet
with a glass of water. Do not chew.
GLUTEN FREE
USUAL DOSE: SEE ENCLOSED DRUG FACTS
Store at 20°-25°C (68°-77°F)
protect from moisture
Keep out of reach of children.
Hospital Use Only.
LC1735
R0
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
INDICATIONS & USAGE SECTION
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
SPL UNCLASSIFIED SECTION
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com
LI1731 Rev. 10/24
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Famotidine 20 mg
OTC - PURPOSE SECTION
Purpose
Acid reducer
WARNINGS SECTION
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 withlightheadedness, sweating, or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequentchest 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 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)
DOSAGE & ADMINISTRATION SECTION
Directions
*Use as directed per healthcare professional.
- adults and children 12 years and over:
- torelieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- toprevent symptoms, swallow 1 tablet with a glass of water at any time from10 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
STORAGE AND HANDLING SECTION
Other information
- read the directions and warnings before use
- store at 20°-25°C (68°-77°F)
- protect from moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-397-9228
HOW SUPPLIED SECTION
How Supplied
NDC 68094-054-65
Unit Dose Packages of 200 Tablets (20 × 10) per Carton