Label: PHAZYME- simethicone capsule, gelatin coated
- NDC Code(s): 0132-0211-12, 0132-0211-24, 0132-0211-36
- 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 May 9, 2023
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- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each fast gel)
- Purpose
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- Warnings
- Directions
- Other information
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
PHAZYME
simethicone capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0211 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 (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color purple Score no score Shape CAPSULE Size 11mm Flavor Imprint Code PZ;250 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0211-12 1 in 1 BOX 04/01/2014 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0132-0211-24 2 in 1 BOX 04/01/2014 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0132-0211-36 3 in 1 BOX 04/01/2014 3 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 04/01/2014 Labeler - C.B. Fleet Company, Inc. (003119054)
