Right Remedies Extra Strength Gas Relief Capsule, Liquid Filled
FDA Label NDC 70692-835
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Right Remedies Extra Strength Gas Relief (NDC 70692-835). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - 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
Uses
for relief of
• pressure, bloating, and fullness commonly referred to as gas
Warnings
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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 between 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
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Packaging
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