Otc - Active Ingredient
Simethicone 250mg
Simethicone
FDA Label NDC 37808-788
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H-e-b for the product Simethicone (NDC 37808-788). 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, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-gas
Inactive Ingredient
D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol
Dosage & Administration
- swallow one or two softgels as symptoms occur
- do not exceed 2 softgels per 24 hours except under the advice and super vision of a physician
Indications & Usage
relieves bloating, pressure or fullness commonly referred to as gas
Warnings
Stop use and ask a doctor if condition persists.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
- store at room temperature between 20-25°C (68-77°F).
- protect from heat, humidity and light.
- TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING
Package Label.Principal Display Panel
788 (788)
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