Active Ingredients
Simethicone 80 mg
Gas Relief
FDA Label NDC 54868-2860
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Gas Relief (NDC 54868-2860). 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 ingredients, purpose, use(s), if pregnant or breast-feeding,, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Use(S)
relieves these symptoms associated with gas
- bloating
- pressure
- stuffed feeling
- fullness
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions
- do not exceed 6 tablets per day unless directed by a doctor
- chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
Other Information
- store at room temperature
- avoid high humidity and excessive heat, above 40°C (104°F)
Inactive Ingredients
dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate
Principal Display Panel
NDC 54868-2860-0
Product Packaging (2860)
Simethicone 80 mg
Gas Relief
•Pressure •Bloating •Discomfort
Fast Acting
Anti Gas
Mind Flavored
100 Tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
50844 REV1104E13712
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
* Please review the disclaimer below.
