Label: LEGEND PREMIUM HEARTBURN CHEWABLE- calcium carbonate tablet

  • 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 June 22, 2020

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  • Active Ingredients

    Calcium carbonate 750 mg.

    Simethicone 80 mg.

  • Purpose

    • Antacid
    • Antigas
  • Warnings


    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product
    ● Do not take more than 5 chewable tablets 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 physician
    ● Constipation may occur

    If pregnant or breast-feeding, ask a health professional before use.
    .

  • Keep out of reach of children.

  • Uses for the relief of


    ● acid indigestion
    ● heartburn
    ● sour stomach
    ● upset stomach associated with these symptoms
    ● bloating, pressure, or stuffed feeling commonly referred to as gas

  • Directions

    ● adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
    ● children under 12 years: consult a doctor
    ● do not take more than 5 chewable tablets in a 24-hour period.

  • Other information

    ● each chewable tablet contains: calcium 300 mg
    ● store at room temperature. Avoid excessive heat above 40oC (104 F).

  • Inactive Ingredients

    Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Red No. 3, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    LEGEND PREMIUM HEARTBURN CHEWABLE 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-844
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITOL (UNII: 506T60A25R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize2mm
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13411-844-2424 in 1 BOX; Type 0: Not a Combination Product06/22/2020
    2NDC:13411-844-3030 in 1 BOX; Type 0: Not a Combination Product06/22/2020
    3NDC:13411-844-6060 in 1 BOX; Type 0: Not a Combination Product06/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/22/2020
    Labeler - ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS (187498279)
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