Otc - Active Ingredient
Active ingredient (in each softgel)
Simethicone 180 mg
Ultra Strength Gas Relief Capsule
FDA Label NDC 41226-717
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 Ultra Strength Gas Relief (NDC 41226-717). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anti-gas
Indications & Usage
Uses
• Relieves bloating, pressure or fullness commonly referred to as gas.
Warnings
Warnings
Otc - Stop Use
Stop use and ask a doctor if condition persists.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
• Swallow one or two softgels as symptoms occur.
• Do not exceed two softgels per 24 hours except under the advice and supervision of a physician.
Storage And Handling
Other information
• Store at room temperature
Inactive Ingredient
Inactive ingredients
FD&C Yellow No. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Otc - Questions
Questions or comments? Call 1-800-632-6900
Package Label.Principal Display Panel
717t-kr-simethicone-30s-label (717t Kr Simethicone 30s Label)
717t-kr-simethicone-30s-ifc (717t Kr Simethicone 30s Ifc)
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