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 Spirit Pharmaceuticals Llc. 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.
Other
Drug Facts
Active Ingredient (In Each Softgel)
Simethicone 180 mg
Purpose
Antigas
Use
for the relief of
■ pressure and bloating commonly referred to as gas
Warnings
Keep out of reach of children.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
■ adults: swallow with water 1 or 2 softgels as needed after
meals and at bedtime
■ do not exceed 2 softgels in 24 hours except under the
advice and supervision of a physician
Other Information
■ store at controlled room temperature 20-25°C (68-77°F)
■ protect from heat and moisture
Inactive Ingredients
FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide
Questions Or Comments?
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ULTRA STRANGTH
GAS RELIEF
Simethicone 180 mg /
anti-gas
Fast relief of:
• bloating
• pressure
• fullness
• gas
50 SOFTGELS
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