Label: SIMETHICONE capsule, liquid filled
- NDC Code(s): 51013-439-02
- Packager: PURACAP PHARMACEUTICAL LLC
- 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 March 22, 2019
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INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-439 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 250 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color PURPLE (Clear) Score no score Shape CAPSULE (Oval) Size 13mm Flavor Imprint Code PC31 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51013-439-02 1 in 1 CARTON 03/25/2019 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 03/25/2019 Labeler - PURACAP PHARMACEUTICAL LLC (962106329)