Label: ANTACID- calcium carbonate tablet

  • NDC Code(s): 17714-025-01, 17714-025-10
  • Packager: Advance Pharmaceutical 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 December 22, 2017

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  • Active Ingredient

    (in each tablet)

    Calcium Carbonate 10 gr (648 mg)

  • Purpose

    Antacid

  • Uses

    relieves

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • Warnings

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

    Stop use and ask a doctor if symptoms last more than 2 weeks.

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

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take one to four tablets daily.
    • do not take more than 4 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks
  • Other Information

    • each tablet contains: calcium 260 mg
    • store at room temperature 15-30 °C (59-86 °F)
    • For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP.
  • Inactive Ingredients

    Croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

  • Questions or Comments

    Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    17ad8654-figure-01

    17ad8654-figure-02

    Calcium Carbonate 10 gr

    Antacid tablets

    NDC: 17714-025-01 – 100 COUNT

    NDC: 17714-025-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

  • INGREDIENTS AND APPEARANCE
    ANTACID 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE648 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (off) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AP;025
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17714-025-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/06/1990
    2NDC:17714-025-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/06/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/06/1990
    Labeler - Advance Pharmaceutical Inc. (078301063)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(17714-025)
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