CALCIUM CARBONATE SUSPENSION [ATLANTIC BIOLOGICALS CORPS]

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CALCIUM CARBONATE SUSPENSION [ATLANTIC BIOLOGICALS CORPS]
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NDC 17856-3117-3
Set ID 38654d22-2f8a-49d2-a1cd-06d341f11323
Category HUMAN OTC DRUG LABEL
Packager Atlantic Biologicals Corps
Generic Name
Product Class
Product Number
Application Number PART331
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL teaspoonful)

    Calcium Carbonate 1250 mg (Equivalent to 500 mg elemental Calcium)

  • Purpose

    Antacid

  • Uses

    relieves:

    • heartburn
    • acid indigestion
    • 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.

    When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

    Keep out of reach of children.

  • Directions

    • Shake well before using.
    • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.
  • Other information

    • store at 20° to 25°C (68° to 77°F)
    • do not freeze
    • packaged with tamper evident seal
  • Inactive ingredients

    calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

  • Questions?

    Call 1-800-845-8210.

  • CALCIUM CARBONATE SUSPENSION

    image description
  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 
    calcium carbonate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-3117(NDC:0121-0766)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1250 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propylparaben (UNII: Z8IX2SC1OH)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    Saccharin Calcium (UNII: 5101OP7P2I)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-3117-3 5 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33112/01/2004
    Labeler - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-3117) , REPACK(17856-3117)
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