Label: UNIFERON 200- iron dextran complex injection

  • NDC Code(s): 42552-741-01, 42552-741-02, 42552-741-03
  • Packager: Pharmacosmos, Inc
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 8, 2023

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  • INDICATIONS & USAGE

    Indications: For prevention or treatment of baby-pig anemia due to iron deficiency.

  • DOSAGE & ADMINISTRATION

    Dosage and Administration: For Intramuscular Injection only.  Prevention: 1mL (200 mg iron) at 1-3 days of age.  Treatment: 1mL (200mg of iron) at the first signs of Iron deficiency

  • GENERAL PRECAUTIONS

    Caution: Use of this product after four (4) weeks of age may cause staining of the ham muscle.

    Refer to folded label attached to this container and read carefully before use.

    TAKE TIME.  OBSERVE LABEL DIRECTIONS

  • STORAGE AND HANDLING

    Store at controlled room temperature 59°-86°F (15°-30°C).

  • SPL UNCLASSIFIED SECTION

    Uniferon® 200 is a sterile solution containing a complex of ferric hydroxide with a low molecular weight dextran fraction equivalent to 200 mg elemental iron per mL with 0.5% phenol as a preservative. Hydrochloric acid and/or sodium hydroxide used for pH adjustment.

    Uniferon® is a Trademark of Pharmacosmos A/S.

    Manufactured for: Pharmacosmos, Inc., 776 Mountain Boulevard, Watchung, NJ 07069

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    For use in animals only.

  • PATIENT PACKAGE INSERT

    42552-741-01 Uniferon 200 expanded content labeling.jpg

    image description

  • Uniferon® 200 Iron Dextran Complex Injection, 200 mg/mL

    42552-741-01 Uniferon 200 100mL label.jpg

    image description

  • INGREDIENTS AND APPEARANCE
    UNIFERON 200 
    iron dextran complex injection
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:42552-741
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOL (UNII: 339NCG44TV) 5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42552-741-0372 in 1 CASE
    1NDC:42552-741-0212 in 1 CARTON
    1NDC:42552-741-01100 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA13470806/24/2021
    Labeler - Pharmacosmos, Inc (878028943)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacosmos A/S309706968api manufacture
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