Label: AG-X- calcium tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 2, 2019

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

  • ACTIVE INGREDIENT

    calcium

  • INACTIVE INGREDIENT

    magnesium, vitamin D, red ginseng powder

  • PURPOSE

    Treatment and prevention of osteoporosis

    Growth and development

    Treatment and prediction of cardiovascular disease due to calcification of blood

    Attention deficit in children, depression, nervous symptoms, nervous stability to anxiety

    Myalgia, Bone Pain, Arthritis, Dysmenorrhea Treatment

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNING

    Please check product ingredients if you have any allergies before taking.

    Please be careful during open the product package.

    Keep product out of direct sunlight, high temperature and humidity.

    Store in a cool dry place.

    Any items past the expiration date or damaged in transit can be exchanged where you originally purchased the item.

    consult your doctor if any abnormal symptoms occur

  • USES

    for oral use only

  • INDICATION & USAGE SECTION

    take two capsules once, two times a day

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    AG-X 
    calcium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55259-8001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM0.76 
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM (UNII: I38ZP9992A)  
    PANAX GINSENG WHOLE (UNII: 9L5JEP7MES)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeOVALSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55259-8001-1120 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/02/2019
    Labeler - APEXEL CO., LTD. (687287979)
    Registrant - APEXEL CO., LTD. (687287979)
    Establishment
    NameAddressID/FEIBusiness Operations
    APEXEL CO., LTD.687287979manufacture(55259-8001)