Active Ingredient (In Each Tablet)
SIMETHICONE 80MG
Simethicone 80mg Tablet, Chewable
FDA Label NDC 55154-2606
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Simethicone 80mg (NDC 55154-2606). 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
Generic Section
Distributed by:
GenDose Pharmaceuticals
Huntersville, NC 28078
Distributed By:
Cardinal Health
Dublin, OH 43017
L58749200924
Principal Display Panel
Simethicone 80mg
Chewable Tablets
10 Chewable Tablets
Bag Label (5e755184 0821 4f92 8f72 84726f7aa407 00)
* Please review the disclaimer below.
