Otc - Active Ingredient
Active Ingredients
Famotidine USP 10mg
Heartburn Relief
FDA Label NDC 52904-448
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Heartburn Relief (NDC 52904-448). 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, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acid Reducer
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 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
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
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
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.
Inactive Ingredient
Inactive ingredients hydroxypropyl
cellulose, hypromellose, iron oxide red, magnesium
stearate, microcrystalline cellulose, polyethylene
glycol 400, pregelatinized starch, talc, titanium
dioxide
Package Label.Principal Display Panel
MM1
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