Label: INTEGRA- iron vitamin supplement capsules capsule

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated September 30, 2014

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  • STATEMENT OF IDENTITY

    Supplement Facts 

     Serving Size: 1 Tablet
    Amount per Serving  % DV*  % Daily value for Pregnant or lactating woman
     Vitamin C(From ProAcorb C**)     40 mg 67% 67%
     Niacin (From ProAcorb C**)         3 mg 15 % 15 %

     Iron                                         125 mg

    (62.5 mg from Ferrous Fumarate)

    (62.5 mg from Polysaccharide Iron Complex)

    		694 % 694 %

    ProAscorb C                                75 mg

    Calcium Ascorbate,Ascorbic Acid, Ascorbyl Palmitate, Niacinamide Ascorbate, Xylitol,

    Sodium Ascorbate, Magnesium Ascorbate, Lysine Acetate, Citrus Bioflavonoids,

    Potassium Ascorbate, Sodium Pyrophosphate, D-Ribofuranose, L-Cysteine, Glutathione,Hesperidin))

    		  ††

    * Percent daily value based on 2,000 calorie intake for adults and children 12 years and older

     †Daily value not established

  • STATEMENT OF IDENTITY

    INDICATIONS  : Integra TM  is indicated for the treatment of iron deficiency anemia which may occur due to an increased need for iron, a defficient intake of iron , or an excessive loss of Iron.

  • WARNINGS

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

  • PRECAUTIONS

    You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465,Decatur,GA 30036

  • SAFE HANDLING WARNING

    Store at controlled room temperature between 15°-30°C (59°-86 °F ). Keep in a cool ,dry place. Capsules are not USP

  • DOSAGE & ADMINISTRATION

    Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

  • HEALTH CLAIM

    Iron vitamin Supplement

  • Packaging

    Integra

  • INGREDIENTS AND APPEARANCE
    INTEGRA 
    iron vitamin supplement capsules capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52747-710
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID40 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN3 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON125 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM ASCORBATE (UNII: 183E4W213W)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    MAGNESIUM ASCORBATE (UNII: 0N1G678593)  
    LYSINE ACETATE (UNII: TTL6G7LIWZ)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    POTASSIUM ASCORBATE (UNII: X5523762RI)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    .BETA.-D-RIBOSE (UNII: IVV837V11N)  
    CYSTEINE (UNII: K848JZ4886)  
    GLUTATHIONE (UNII: GAN16C9B8O)  
    HESPERADIN (UNII: PTR491OS14)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:52747-710-6090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement04/01/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)19 mm
    scoring1
    imprint
    Labeler - US Pharmaceutical Corporation (048318224)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD SUB, LLC.063753431manufacture(52747-710)
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