Label: TANDEM- ferrous fumarate, polysaccharide iron complex capsule

  • NHRIC Code(s): 52747-900-90
  • Packager: U.S. Pharmaceutical Corporation
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated May 16, 2022

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  • STATEMENT OF IDENTITY

     Supplement Facts
     Serving Size: 1 Capsule
     Amount Per Serving%DV*
     Iron106 mg589%
        (53 mg from Ferrous Fumarate)
        (53 mg from Polysaccharide Iron Complex)
     * Percent daily value based on 2,000 calorie diet

    Other Ingredients: Microcrystalline Cellulose, Gelatin, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FDA/E172 Yellow Iron Oxide, FDA/172 Black Iron oxide and FDA/E172 Red Iron Oxide

    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.

    INDICATIONS: The treatment of iron deficiency anemia, which may occur due to an increased need for iron, a deficient intake of iron or an excessive loss of iron.

  • SIDE EFFECTS:

    Gastrointestinal disturbance (anorexia, nausea, diarrhea, constipation) occur occasionally but are usually mild and subside with continuation of therapy.

  • DOSAGE:

    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. If you are pregnant or nursing a baby, seek the advice of a health professional before using the product.

    HOW SUPPLIED: Tandem® are light brown opaque capsules printed radially in red with "Tandem" on the cap and 2 parallel lines of repeated "US" logo on the body. Available in box of 90 blister packed capsules (52747-0900-90). The listed product number is not a National Drug Code. Instead, US Pharmaceutical Corporation has assigned this product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

  • SAFE HANDLING WARNING

    Do not purchase if any portion of product is opened. Store at room temperature 15° to 30°C (59° to 86°F) and dry place.

  • 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.

  • HEALTH CLAIM

    Ferrous Fumarate / Polysaccharide Iron Complex Supplement Capsules

  • Packaging

    Capsule outer carton

  • INGREDIENTS AND APPEARANCE
    TANDEM 
    ferrous fumarate, polysaccharide iron complex capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52747-900
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION53 mg
    IRON POLYMALTOSE (UNII: UM5219H89V) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION53 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:52747-900-909 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement04/01/2006
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)19 mm
    scoring1
    imprint
    Labeler - U.S. Pharmaceutical Corporation (079467662)