Label: FOSTER AND THRIVE EXTRA STRENGTH ANTACID 127AF EXTRA STRENGTH ANTACID ASSORTED FRUIT- calcium carbonate tablet, chewable

  • NDC Code(s): 70677-1076-1
  • Packager: Strategic Sourcing Services LLC
  • 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 July 12, 2023

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  • ACTIVE INGREDIENT (in each tablet)

    Calcium carbonate 750 mg

  • PURPOSE

    Antacid

  • USE(S)

    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 10 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/BREASTFEEDING,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    .

  • DIRECTIONS

    • adults and children 12 years of age and over:
    • wet in mouth before chewing
    • chew 2-4 tablets as symptoms occur, or as directed by a doctor.
  • OTHER INFORMATION

    • each tablet contains: elemental calcium 300 mg, magnesium 10 mg
    • do not use if printed seal under cap is torn or missing. 
    • store below 30º C (86ºF).
  • 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 blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

  • PRINCIPAL DISPLAY PANEL

    NDC 70677-1076-1

    COMPARE TO TUMS® EXTRA STRENGTH ACTIVE INGREDIENT*
    Foster and Thrive TM
    EXTRA STRENGTH
    Antacid Tablets
    Calcium Carbonate 750 mg

    Relieves:

    • Heartburn
    • Acid Indigestion

    ASSORTED FRUIT 

    96 CHEWABLE TABLETS

    F and T-127AF


  • INGREDIENTS AND APPEARANCE
    FOSTER AND THRIVE EXTRA STRENGTH ANTACID 127AF  EXTRA STRENGTH ANTACID ASSORTED FRUIT
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1076
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGE, YELLOW, GREEN, PINK (reddish pink) Scoreno score
    ShapeROUNDSize16mm
    FlavorCHERRY, LEMON, LIME, ORANGEImprint Code G127
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1076-196 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33107/12/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70677-1076)
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