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Tandem DHA
  • Professionals
  • FDA PI

Tandem DHA

Generic name:ferrous fumarate, iron, ascorbic acid, pyridoxine hydrochloride, omega-3-acid ethyl esters and folic acid
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 opaque pink capsule contains;
Ferrous Fumarate (Elemental Iron) . . . . . . . . . . . . . . . 15 mg
Vitamin C (Sodium Ascorbate) . . . . . . . . . . . . . . . . . 20 mg FolicAcid␣␣ ..... 1mg
Vitamin B6 (Pyridoxine HCI)␣␣ . . . . . . . . . . . . . . . . . . . 25 mg Omega-3FattyAcids␣␣ ..... 310.1mg
PPolysaccharide Iron Complex (Elemental Iron) ␣␣ . . . . . . (Equivalent to about 30 mg of elemental iron)
((Derived from 450 mg Fish Oil)␣␣
Docosahexaenoic Acid (DHA)␣␣ . . . . . . . . . . . . ␣␣ Eicosapentaenoic Acid (EPA)␣␣ . . . . . . . . . . . . . .
2215.12 mg 53.46 mg

Clinical Studies: The licensee U.S. Pharmaceutical Corporation and JLM Pharmatech, Inc. had jointly sponsored new research pertaining to this formulation (Liesa M. Diehl August 2005: A 14-Day Comparative Pharmacokinetic Study of Ferrous Fumarate and Ferrous Fumarate-Polysaccharide Iron Complex Administered by the Oral (Gavage) Route to Rats, Charles River Laboratories, Preclinical Services: Spencerville, OH). (Personal Communication, Study number NEM00001, August 2005). 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 fuma