OYSTER SHELL CALCIUM (CALCIUM CARBONATE) TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]

OYSTER SHELL CALCIUM (CALCIUM CARBONATE) TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]
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NDC 76413-322-01
Set ID 79a22a47-41c3-4b9b-8e9f-92b1b2999ba2
Category DIETARY SUPPLEMENT
Packager Central Texas Community Health Centers
Generic Name
Product Class
Product Number
Application Number
  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving% Daily Value
    Calcium (as Oyster Shell)500 mg.50%

    OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Hypromellose, Polydextrose, Titanium Dioxide, Soy Polysaccharide, Talc, Sodium Lauryl Sulfate and Triglycerides.

    Contains: Soy and Shellfish

  • DIRECTIONS

    For adults, take one (1) tablet daily preferably with a meal. As a reminder, discuss the supplements and medications you take with your health care providers.

  • WARNING

    If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.

  • FREE OF

    Yeast, wheat, milk or milk derivatives, lactose, sugar, preservatives, artificial color, artificial flavor, sodium (less than 5 mg per serving).

  • HEALTH CLAIM

    Adequate calcium throughout life, as part of a well balanced diet, may reduce the risk of osteoporosis*

    * THIS STATEMENT HAS NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.
  • SAFE HANDLING WARNING

    KEEP OUT OF THE REACH OF CHILDREN. STORE AT ROOM TEMPERATURE AND AVOID EXCESSIVE HEAT.

    TAMPER RESISTANT: DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

  • HEALTH CLAIM

    Distributed by: MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive, Livonia, MI 48150, USA
    Questions or Comments? (800) 616-2471

    LOT # & EXP. DATE:
    M-29 Rev. 04/16
    11098-04-16

  • PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label

    CommUnityCare Federally Qualified Health Centers

    CALCIUM
    CARB
    TABS
    500MG
    #60

    Date:

    Name:
    Dr.

    TAKE AS DIRECTED BY PHYSICIAN.

    01/01/01

    123456

    CALCIUM CARBONATE 500MG #60 TABS NDC 76413-322-01

    Batch:
    123456
    Lot:
    123456
    Exp:
    01/01/01

    MAJOR

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    OYSTER SHELL CALCIUM 
    calcium carbonate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76413-322
    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
    Croscarmellose sodium (UNII: M28OL1HH48)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Polydextrose (UNII: VH2XOU12IE)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Talc (UNII: 7SEV7J4R1U)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:76413-322-0160 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/01/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)1 mm
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK, RELABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Major Pharmaceuticals383359612MANUFACTURE

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