Active Ingredient (In Each Softgel)
Simethicone 125 mg
Hyvee Extra Strength Gas Relief Softgel Capsule, Liquid Filled
FDA Label NDC 42507-835
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Hyvee Extra Strength Gas Relief Softgel (NDC 42507-835). 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 (in each softgel), purpose, use, otc - keep out of reach of children, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Use
for the relief of
• pressure, bloating, and fullness commonly referred to as gas.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 20–25°C (68–77°F)
▪ protect from light, heat and moisture
Inactive Ingredients
ammonium hydroxide, black iron oxide, D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, isopropyl alcohol, n-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments?
1-888-577-8033 Monday - Friday 8am - 4pm EST
Packaging
Hyveeesgasrelief-30 (42507835 5)
Hyveeesgasrelief-50 (42507835 6)
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