Label: PHAZYME- simethicone and calcium carbonate tablet, chewable
- NDC Code(s): 0132-0507-24
- 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 October 19, 2017
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- Official Label (Printer Friendly)
- Active Ingredients (in each chew)
- Uses for the relief of:
- When using this product
- If pregnant or breast-feeding
- Ask a doctor or pharmacist before use if you are
- Keep out of reach of children
- Directions
- Other Information
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Inactive Ingredients
Acacia, beeswax, carnuba wax, citric acid, cornstarch, corn syrup, FD&C red #40 aluminum lake, flavor, modified starch, phosphoric acid, polyvinylpyrolidone, pregelatinized modified corn starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil, water
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INGREDIENTS AND APPEARANCE
PHAZYME
simethicone and calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0507 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 750 mg in 24 DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 250 mg in 24 Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) CITRIC ACID ACETATE (UNII: DSO12WL7AU) STARCH, CORN (UNII: O8232NY3SJ) CORN SYRUP (UNII: 9G5L16BK6N) FD&C RED NO. 40 (UNII: WZB9127XOA) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) PHOSPHORIC ACID (UNII: E4GA8884NN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBIC ACID (UNII: X045WJ989B) SORBITOL (UNII: 506T60A25R) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score no score Shape ROUND Size 12mm Flavor CHERRY Imprint Code PA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0507-24 24 in 1 JAR; Type 0: Not a Combination Product 03/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 03/01/2016 Labeler - C.B. Fleet Company, Inc. (003119054)