Label: ONLY FOR ANTACID- calcium carbonate 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 April 29, 2019

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  • DRUG FATCS

  • Active ingredient (in each tablet)

    Calcium Carbonate 500mg

  • Purpose

    Antacid

  • Uses:

    • 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.

    Do not use

    • 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.

    • May cause constipation.
    • May have laxative effect.

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

    Keep out of reach of children.

  • Directions

    • adults and children 12 years of age and over:

    chew 2 - 4 tablets as symptoms occur, or as directed by doctor.

  • Other Information

    • each tablet contains: elemental calcium 200mg
    • store at room temperature between 20-25°C (68-77°F).
  • Inactive Ingredients

    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.

  • Questions Or Comments ?

    1-833-665-9444.

  • SPL UNCLASSIFIED SECTION

    NDC: 73006-118-41

    Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

    www.onlyfor.com

    Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

    Tear along perforation push product through foil

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ONLY FOR  ANTACID
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colororange, yellow, green, pink (reddish pink) Scoreno score
    ShapeROUND (Flat face) Size16mm
    FlavorImprint Code GDC126
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-118-411 in 1 CARTON03/29/2019
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/29/2019
    Labeler - O4 Global Trading Usa, Llc (081226861)
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