Label: SIMETHICONE- dimethicone capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 48769-112-99 - Packager: Softech Pharma Pvt. Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 29, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMETHICONE
dimethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48769-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 180 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color red Score no score Shape OVAL Size 8mm Flavor Imprint Code RP112 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48769-112-99 1000 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 01/15/2012 Labeler - Softech Pharma Pvt. Ltd. (677111277) Establishment Name Address ID/FEI Business Operations Softech Pharma Pvt. Ltd. 677111277 manufacture