FDA Label for Ultra Strength Gas Relief Softgels

View Indications, Usage & Precautions

Ultra Strength Gas Relief Softgels Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates 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.

Drug Facts




Active Ingredient (In Each Softgel)



Simethicone 180 mg


Purpose



Antigas


Uses



for the relief of pressure and bloating 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.


Directions



• adults and children 12 years or older: 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 light, heat, and moisture


Inactive Ingredients



ammonium hydroxide, black iron oxide, FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, n-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan anhydrous, titanium dioxide


Questions Or Comments?



Call 1-888-423-0139


Packaging




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