Active Ingredient
Active ingredient (in each softgel)
Simethicone 125 mg
Extra Strength Gas Relief Capsule
FDA Label NDC 41226-722
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Extra Strength Gas Relief (NDC 41226-722). 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, purpose, use, warning, 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
Purpose
Purpose
Anti-gas
Use
Use for the relief of
- pressure, bloating and fullness commonly referred to as gas
Warning
Warning
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Directions
- adults and children 12 years and older: 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
Other information
- store at room temperature
- protect from light, heat and moistur e
Inactive Ingredients
Inactive ingredients
D&C Yellow 10, FD&C Red #40, FD&C Blue 1, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
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