Label: ANTACID REGULAR STRENGTH- calcium carbonate 500mg tablet, chewable

  • 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 14, 2020

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  • ACTIVE INGREDIENT

    Sennosides USP 15mg

  • INACTIVE INGREDIENT

    adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.

  • INDICATIONS & USAGE

    Relieves:

    • acid indigestion
    • heartburn
  • WARNINGS

    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 15 tablets in a 24-hour period, or 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 health professional before use.

    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    Antacid

  • OTHER SAFETY INFORMATION

    * Each tablet contains: elemental calcium 200mg.

    * Store at room temperature. Keep the container tightly closed.

  • PRINCIPAL DISPLAY PANEL

    pg 1pg 2pg 3

  • INGREDIENTS AND APPEARANCE
    ANTACID REGULAR STRENGTH 
    calcium carbonate 500mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Coloryellow, green, pink (Reddish Pink) , orangeScoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT ((Orange, Lemon, Lime, Cherry)) Imprint Code GDC;126
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-118-4545 in 1 PACKAGE; Type 0: Not a Combination Product05/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/09/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)
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