FDA Label for Simethicone
View Indications, Usage & Precautions
Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product H-e-b. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Simethicone 250mg
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
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