Other
20 mg
For Hospital Use Only
Drug Facts
GLUTEN FREE
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
For inquiries call Precision Dose, Inc.
at 1-800-397-9228 or email
[email protected]
LI1465 Rev. 08/23
Famotidine Tablet, Film Coated
FDA Label NDC 68094-054
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Precision Dose, Inc. for the product Famotidine (NDC 68094-054). 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 other, active ingredient (in each tablet), purpose, uses, allergy alert, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Famotidine 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
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
Otc - Ask Doctor/Pharmacist
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- Use as directed per healthcare professional.
- 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
Other Information
- read the directions and warnings before use
- store at 20°-25°C (68°-77°F)
- protect from moisture
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
Questions Or Comments?
1-800-397-9228
How Supplied
NDC 68094-054-65
Unit Dose Packages of 200 Tablets
(20 × 10) per Carton
Principal Display Panel - 20 Mg Tablet Blister Pack Carton Label
Precision Dose™
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.
LC1464
R1
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
Principal Display Panel (20 mg Tablet Blister Pack Carton Label)
* Please review the disclaimer below.
