Active Ingredient (In Each Softgel)
Simethicone 125 mg
Gas Relief Capsule, Liquid Filled
FDA Label NDC 70000-0529
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health (leader) 70000 for the product Gas Relief (NDC 70000-0529). 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, uses, if pregnant or breast-feeding,, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Uses
for the relief of pressure, bloating, and fullness commonly referred to as gas.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 physican
Other Information
- store between 20-25°C (68-77°F)
- do not refrigerate
- protect from light, heat, and moisture
Inactive Ingredients
D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO GAS-X® EXTRA STRENGTH active ingredient**
Extra Strength
Gas Relief
simethicone 125 mg | Anti-gas
For Relief of:
- Pressure
- Bloating
- Discomfort
SOFTGELS
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Extra Strength.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
Product Label
LEADER Extra Strength Gas Relief
* Please review the disclaimer below.
