Label: PHAZYME ULTIMATE- simethicone capsule, liquid filled
- NDC Code(s): 0132-0217-10, 0132-0217-20
- Packager: C.B. Fleet Company, Inc.
- 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 December 8, 2022
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INGREDIENTS AND APPEARANCE
PHAZYME ULTIMATE
simethicone capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0217 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 500 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color blue Score no score Shape CAPSULE Size 11mm Flavor Imprint Code PZ500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0217-10 1 in 1 BOX 02/15/2021 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0132-0217-20 2 in 1 BOX 02/15/2021 2 10 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 02/15/2021 Labeler - C.B. Fleet Company, Inc. (003119054)