Simethicone
FDA Label NDC 11822-1569
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Simethicone (NDC 11822-1569). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, 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 250 mg
Purpose
Anti-gas
Uses
relives bloating, pressure or fullness commonly referred to as gas
Warnings
Otc - Stop Use
Stop use and ask a doctor if condition persists
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
• Swallow one or two softgels after a mea • do not exceed two softgels in 24 hours except under the advice and supervision of a physician
Other Information
• store at room temperature 59-86°F (15-30°C)
Inactive Ingredients
D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide
Questions Or Comments?
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Distributed by:
RITE AID
30 Hunter Lane, Camp Hill, PA 17011
www.riteaid.com
Made in India
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