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.

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Active Ingredients (in each chew)

Calcium carbonate 750mg............... Antacid

Simethicone 250mg.................. Anti-gas

Uses for the relief of:

When using this product

If pregnant or breast-feeding

Ask a doctor before use.

Ask a doctor or pharmacist before use if you are

Now taking a prescription drug. Antacids may interact with certain prescription drugs.

Keep out of reach of children

Keep out of reach of children.

Directions

Adults and children 12 years and older:

Chew and swallow 1 to 2 chews as symptoms occur or as directed by a doctor.

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 www.phazyme.com

Principle Display Panel

Phazyme Gas & Acid Chews Bottle

PHAZYME 
simethicone and calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0507
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 mg  in 24 
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg  in 24 
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize12mm
FlavorCHERRYImprint Code PA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0507-2424 in 1 JAR; Type 0: Not a Combination Product03/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/01/2016
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 10/2017
Document Id: 428c1326-85da-4bc5-a2ae-1f7e10e31ef0
Set id: 848d7c23-a12b-49c4-8fda-da15efca33ad
Version: 3
Effective Time: 20171019
 
C.B. Fleet Company, Inc.