Otc - Active Ingredient
RANITIDINE HYDROCHLORIDE
Aptidine
FDA Label NDC 46084-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A P J Laboratories Limited for the product Aptidine (NDC 46084-031). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acid reducer
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
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 foods and beverages
Warnings
Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers
Dosage & Administration
adults and children 12 years and over:
to relieve symptoms, swallow 1 tablet with a glass of water
to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
can be used up to twice daily (do not take more than 2 tablets in 24 hours)
children under 12 years: ask a doctor
Inactive Ingredient
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
POVIDONE K30
METHYLPARABEN
TALC
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
Package Label.Principal Display Panel
Product (Mm1 Aptidine)
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