Otc - Active Ingredient
Famotidine USP 20mg
Allergy alert: Do not use if you are allergic to famotidine or other acid reducer
Goodmeds Famotidine 20mg 500 Count Tablet
FDA Label NDC 82725-4047
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Goodmeds Famotidine 20mg 500 Count (NDC 82725-4047). 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
Acid Reducer
Indications & Usage
- 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
Otc - 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 reducer
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 vomit
- 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 as 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:
- 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
- ask a doctor
children under 12 years:
Other Safety Information
- read the directions and warnings before use
- safety sealed: do not use if imprinted foil under bottle cap is opened or torn
- store at 20°–25°C (68°–77°F)
- protect from moisture
Otc - Questions
Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST
Inactive Ingredient
carnauba wax, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, talc, titanium dioxide
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