Label: CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (calcium carbonate 10gr- 648 mg tablet

  • NDC Code(s): 73057-377-08, 73057-377-11
  • Packager: Ulai Health 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 22, 2019

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Calcium Carbonate 10 gr (648 mg)

  • Purpose

    Antacid

  • Uses

    for the relief of

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

  • Do not use

    • more than 4 tablets in 24 hours
    • the maximum dosage for more than two weeks, unless directed by a doctor

    Ask a doctor before use if you have

    • kidney stones
    • a calcium-restricted diet

    Ask a doctor or pharmacist before use if you are

    • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.


  • Directions

     adults and children 12 years and over    take 1 to 4 tablets daily or as directed by a doctor

  • Other information

    • each tablet contains: calcium 260 mg
    • store at 20-25oC (68-77oF)
  • Inactive ingredients

    acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

  • Questions or comments?

    (866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 73057-377-11

    Manufactured in the USA

    Calcium

    Carbonate

    Antacid

    10 gr (648 mg)

    1000 TABLETS

    Ulai Calcium Carbonate 648 mg Tab 1000 ct. Label

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 10 GR (648 MG)  (ANTACID)
    calcium carbonate 10gr (648 mg) tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-377
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE648 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code PH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-377-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2019
    2NDC:73057-377-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/01/2019
    Labeler - Ulai Health LLC (081181535)
    Registrant - Pharbest Pharmaceuticals Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals Inc.557054835manufacture(73057-377) , analysis(73057-377) , pack(73057-377) , label(73057-377)