Active Ingredient(S)
Simethicone 125mg
Gas Relief Capsule
FDA Label NDC 83324-352
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Gas Relief (NDC 83324-352). 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(s), purpose, use(s), directions, other information, inactive ingredients, questions/comments, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti gas
Use(S)
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
Directions
adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician.
Other Information
- store at room temperature 20°– 25°C (68°– 77°F)
- protect from light, heat and moisture
- do not use if blister unit is torn or open
Inactive Ingredients
D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink
Questions/Comments
Call 1-800-935-2362 Monday through Friday 9 AM – 5 PM
Principal Display Panel
Blister Carton
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