TANDEM DHA vitamin- mineral omega-3 supplement capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7)

Available from:

US Pharmaceutical Corporation

INN (International Name):

FERROUS FUMARATE

Composition:

IRON 15 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

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._
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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