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Drug Facts
Gas Relief Capsule
FDA Label NDC 68391-722
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bjwc (berkley & Jensen / Bj's) for the product Gas Relief (NDC 68391-722). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each softgel)
Simethicone 125 mg
Otc - Purpose
Purpose
Antigas
Indications & Usage
Use for the relief of
- pressure, bloating and fullness commonly referred to as gas
Warnings
Warning
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
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 Safety Information
Other information
- store at room temperature
- protect from light, heat and moisture
Inactive Ingredient
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
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
722T 240ct label
722T 240ct Carton
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