UNIFERON 200- iron dextran complex injection

Uniferon 200 by

Drug Labeling and Warnings

Uniferon 200 by is a Animal medication manufactured, distributed, or labeled by Pharmacosmos, Inc, Pharmacosmos A/S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

INGREDIENTS AND APPEARANCE

UNIFERON 200 
iron dextran complex injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 42552-741
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOL (UNII: 339NCG44TV)	5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42552-741-03	72 in 1 CASE
1	NDC: 42552-741-02	12 in 1 CARTON
1	NDC: 42552-741-01	100 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA134708	06/24/2021

Labeler - Pharmacosmos, Inc (878028943)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacosmos A/S		309706968	api manufacture