Active Ingredient (In Each Tablet)
SIMETHICONE 80MG
Simethicone 80mg Tablet, Chewable
FDA Label NDC 77333-812
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gendose Pharmaceuticals, Llc for the product Simethicone 80mg (NDC 77333-812). 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 active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTI-GAS
Uses
- RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT
Warnings
- GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Directions
- ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE.
- DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.
Other Information
- EACH TABLET CONTAINS: CALCIUM 60MG
- STORE AT ROOM TEMPERATURE
Inactive Ingredients
DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC CALCIUM PHOSPHATE
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