Active Ingredient (In Each Softgel)
Simethicone 500 mg
Gas Relief Capsule, Liquid Filled
FDA Label NDC 80513-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Gas Relief (NDC 80513-119). 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 softgel), purpose, use, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of chindren., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Use
for the relief of pressure, bloating, and fullness, commonly referred to as gas.
Stop Use And Ask A Doctor If
condition persists.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Chindren.
Directions
- adults and children 12 years and older:swallow with water 1 softgel as needed after meals or at bedtime
- do not exceed 1 softgel in 24 hours except under the advice and supervision of a physician
Other Information
- store at 20° to 25°C (68° to 77°F)
- protect from light, heat and moisture
Inactive Ingredients
Gelatin, glycerin, purified water, sorbitol.
Questions?
call 1-800-630-8895
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