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

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients (in each chew)

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

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

  • Uses for the relief of:

    • pressure and bloating commonly referred to as gas
    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • 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
  • 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

    • Each chew contains: calcium 300mg
    • Store between 59-77F.
    • Don't use if allergic to this product or its ingredients.
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!