Otc - Active Ingredient
Active ingredient (in each tablet)
Famotidine USP 10 mg
Original Strength Heartburn Prevention Tablet
FDA Label NDC 41226-719
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Original Strength Heartburn Prevention (NDC 41226-719). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acid reducer
Indications & Usage
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
Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Otc - 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
Otc - Ask Doctor
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.
Otc - Stop Use
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)
Dosage & Administration
Directions
- adults and children 12 years and over:
- children under 12 years: ask a doctor
-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
-do not use more than 2 tablets in 24 hours
Other Safety Information
Other information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20°-25°C (68°-77°F)
- protect from moisture
- FDA approved dissolution test specifications differ from USP
Inactive Ingredient
Inactive ingredients carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide
Otc - Questions
Questions or comments?Call 1-800-632-6900
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