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Tandem OB
  • Professionals
  • FDA PI

Tandem OB

Generic name:ferrous fumarate, iron, sodium ascorbate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, niacinamide, calcium pantothenate, magnesium sulfate and cupric sulfate
Dosage form: capsule
Drug classes:Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION: Each capsule contains:
Ferrous Fumarate (anhydrous) .....162 mg (Equivalent to about 106 mg of Elemental Iron) PolysaccharideIronComplex .....115.2mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..... 200 mg
Folic Acid ..... 1 mg Thiamine Mononitrate (B1)..... 10 mg Riboflavin (B2)..... 6 mg Niacinamide .....30 mg
d-Calcium Pantothenate (B5)..... 10 mg
Pyridoxine HCl (B6) .....5 mg
Biotin (B7)..... 300 mcg Cyanocobalamin (B12) .....10 mcg Copper (as Copper Sulfate).....800 mcg
Magnesium (as Magnesium Sulfate).....6.9 mg
Manganese (as Manganese Sulfate).....1.3 mg
Zinc (as Zinc Sulfate) ..... 18.2 mg

Clinical Studies: Because Ferrous Fumarate is an organic complex, it contains no free ions, either ferric or ferrous. Polysaccharide Iron Complex is clinically non-toxic. Prior studies in rats demonstrated that Polysaccharide Iron Complex (PIC), administered as a single oral dose to Sprague Dawley rats did not produce evidence of toxicity at a dosage level of 5000 mg Iron/kg: (An Acute Oral Toxicity Study in Rats with Polysaccharide-Iron Complex. T.N.Merriman, M. Aikman and R.E. Rush, Springborn Laboratories. Inc. Spencerville, Ohio Study No. 3340.1 March - April 1994). Other clinical studies had demonstrated that Polysaccharide Iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. Picinni and Ricciotti suggested in 1982, that "the therapeutic effectiveness of Polysaccharide Iron Complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells..." and that, "it has been exceptionally well tolerated by all patients" (Pic