Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7)
US Pharmaceutical Corporation
FERROUS FUMARATE
IRON 15 mg
PRESCRIPTION DRUG
unapproved drug other
TANDEM DHA - VITAMIN- MINERAL OMEGA-3 SUPPLEMENT CAPSULE US PHARMACEUTICAL CORPORATION _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._ ---------- SEE ALL PRESCRIBING INFORMATION FOR TANDEM DHA 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 read_full_document