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
Drug Label Information
Updated February 4, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
SPL UNCLASSIFIED SECTION
PHAZYME- simethicone and calcium carbonate tablet, chewable
C.B. Fleet Company, Inc.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 Facts
- Active Ingredient (in each chew)
- Purpose
- Use
-
Warnings
When using this product
- Do not take more than 2 chews in a 24-hour period
- Do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor
- Do not take more than 2 chews in a 24-hour period
- Directions
- Other information
-
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
-
Questions?
1-855-727-4277 or phazyme.com
Dist. by Medtech Products Inc., Tarrytown, NY 10591
A Prestige Brands Company
©2020 Trade dress is owned by C.B. Fleet Company, Inc.. All rights reserved.
Made & Packaged in the USA
PZUS006202
Tamper Evident:
Do not use if foil imprinted “SEALED FOR YOUR PROTECTION” under cap is torn or missing
*The strongest OTC gas relief per 2 chewables
- PRINCIPAL DISPLAY PANEL
-
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 Drug M002 03/01/2016 12/31/2025 Labeler - C.B. Fleet Company, Inc. (003119054)