Gas Relief Capsule, Liquid Filled
FDA Label NDC 80513-111
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 80513-111). 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, use, otc - keep out of reach of children, directions, other information, inactive ingredients, 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 125 mg
Purpose
Antigas
Use
for the relief of pressure, bloating, and fullness, commonly referred to as gas.
Otc - Keep Out Of Reach Of Children
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 Ingredients
FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.
Questions?
call 1-800-630-8895
Other
Distributed by:
Advanced Rx LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A.
Package Label.Principal Display Panel
NDC 80513-111-12
EXTRA STRENGTH
GAS RELIEF
Simethicone 125 mg
• RELIEVES GAS FAST
• PRESSURE
• BLOATING
• DISCOMFORT
120 SOFTGELS
Carton (Label 125mg)
* Please review the disclaimer below.
