Active Ingredient (In Each Capsules)
Simethicone USP, 180 mg
Ultra Strength Gas Relief Capsule, Liquid Filled
FDA Label NDC 69452-543
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Ultra Strength Gas Relief (NDC 69452-543). 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 capsules), purpose, uses, warnings, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Purpose
Antigas
Uses
relieves bloating, pressure, fullness, commonly referred to as gas.
Warnings
Warnings
Stop Use And Ask A Doctor If
condition persists.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Directions
■ adults: swallow with water 1 capsule or 2 capsules as needed after meals and at bedtime
■ do not exceed 2 capsules in 24 hours except under the advice and supervision of a physician
Other Information
■ store at 20°-25°C (68°-77°F)
■ protect from light, heat and moisture.
Inactive Ingredients
FD&C yellow no. 6, gelatin, glycerin, peppermint oil, pharmaceutical imprinting ink, purified water, sorbitol, and titanium dioxide
Questions?
call 1-888-235-2466
Other
***This product is not manufactured or distributed by the owner of the registered trademark Gas-X® Extra Strength.
Manufactured for:
BIONPHARMA
Princeton, NJ 08540
MADE IN INDIA
Code:TN/Drugs/TN00003701
PMP01847
L0001253 R0326
180 Mg Label
***compare tothe active ingredient in
Gas-X® Extra Strength
a+ health
extra strength
gas relief
simethicone capsules USP, 180 mg
antigas
relieves: ● bloating ● pressure
● fullness ● discomfort
300 SOFTGELS**
**liquid-filled capsules
Label (Label)
* Please review the disclaimer below.
