Gas Relief Capsule, Liquid Filled
FDA Label NDC 80513-117
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 80513-117). 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, otc - active ingredient, otc - purpose, indications & usage, warning, 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
Otc - Active Ingredient
Active Ingredients (in each softgel)
Simethicone 125 mg
Otc - Purpose
Purpose
Antigas
Indications & Usage
Usefor the relief of pressure, bloating, fullness, commonly referred to as gas.
Warning
If pregnant or breast-feeding,ask a health professional before use.
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 4 softgels 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
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredient
D&C Yellow 10, FD&C Blue 1, Edible Ink, Gelatin, Glycerin, Peppermint oil, POLYSORB, Purified water, Titanium dioxide.
Otc - Questions
Questions?
call
1-800-630-8895
* Please review the disclaimer below.
