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 Softech Pharma Pvt. Ltd. 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.

Active Ingredient (Per Soft Gel)



Simethicone 125 mg


Purpose



Antigas


Uses



Relieves pressure and bloating commonly referred to as gas


Warnings



Keep out of reach of children


Directions



  • Do not exceed 4 softgels in 24 hours
  • Adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime

Other Information



store at 200 - 250C


Inactive Ingredients



D and C yellow 10, FD and C blue 1, FD and C red 40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide


Package Label.Principal Display Panel




Otc - Keep Out Of Reach Of Children



Keep out of Reach of Children


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