Drug Facts
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Extra Strength Gas Relief Capsule
FDA Label NDC 85828-722
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grocery Outlet, Inc. for the product Extra Strength Gas Relief (NDC 85828-722). 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 drug facts, active ingredient (in each softgel), purpose, use, warning, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Simethicone 125 mg
Purpose
Antigas
Use
for the relief of
- pressure, bloating and fullness commonly referred to as gas
Warning
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Keep Out Of Reach Of Children.
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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
- store at room temperature
- protect from light, heat and moisture
Inactive Ingredients
D&C Yellow #10, FD&C blue 1, FD&C red #40, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments?
Call 1-877-290-4008
Package Label.Principal Display Panel
Simethicone-ifc-30s (Simethicone Ifc 30s)
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