Active Ingredient (In Each Softgel)
Simethicone 180 mg
Gas Relief Capsule, Liquid Filled
FDA Label NDC 69842-832
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Gas Relief (NDC 69842-832). 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, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Purpose
Antiflatulent (Antigas)
Uses
- relieves bloating, pressure, or 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.
Directions
- swallow one or two softgels as needed after a meal
- do not exceed two softgels per day except under the advice and supervision of a physician
Other Information
- store between 15-30°C (59-86°F)
- protect from heat and moisture
Inactive Ingredients
FD&C red #40*, FD&C yellow #6, gelatin, glycerin, purified water, white printing ink*
*contains one or more of these ingredients
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Phazyme® Ultra Strength**
ULTRA STRENGTH
GAS RELIEF
SIMETHICONE 180 mg
Anti-gas
Relief of:
- Gas discomfort
- Pressure
- Bloating
SOFTGEL
LIQUID-FILLED SOFTGELS
**This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
Package Label
CVS HEALTH Ultra Strength Gas Relief
* Please review the disclaimer below.
