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Drug Facts
Simethicone
FDA Label NDC 68210-4154
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Simethicone (NDC 68210-4154). 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 other, active ingredient (in each softgel), purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Simethicone 180 mg
Purpose
Antigas
Use
for the relief of
■ pressure and bloating commonly referred to as gas
Warnings
Keep out of reach of children.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
■ adults: swallow with water 1 or 2 softgels as needed after
meals and at bedtime
■ do not exceed 2 softgels in 24 hours except under the
advice and supervision of a physician
Other Information
■ store at controlled room temperature 20-25°C (68-77°F)
■ protect from heat and moisture
Inactive Ingredients
FD&C yellow#6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide
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