CONCEPT DHA- vitamin- mineral omega-3 supplement capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR), IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A), CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - U

Available from:

U.S. Pharmaceutical Corporation

INN (International Name):

FERROUS FUMARATE

Composition:

FERROUS FUMARATE 53.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DESCRIPTION: Each capsule contains: Ferrous Fumarate (Elemental Iron) . . . . . . . . . . 17.5 mg PolysaccharideIronComplex(ElementalIron).. 17.5mg (Equivalent to about 35 mg of elemental iron) Vitamin C (from ProAscorb C‡)    .    .    .    .    .    .    .    .    .    .    .    .    25 mg FolicAcid.............................. 1mg ThiamineMononitrate(B1) ................ 2mg Riboflavin(B2) .......................... 3mg Niacin (B3, from ProAscorb C‡)    .    .    .    .    .    .    .    .    .    .    .    .    1.8 mg d-CalciumPantothenate(B5)................ 5mg PyridoxineHCI(B6) .................... 25mg Biotin (B7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 mcg Cyanocobalamin(B12) ................ 12.5mcg Copper(asCopperSulfate).................. 2mg Magnesium(asMagnesiumSulfate) . . . . . . . . Zinc(asZincSulfate).................... Omega-3 Fatty Acids .    .    .    .    .    .    .    .    . ........... (Derived from 310 mg Fish Oil) Docosahexaenoic Acid (DHA) . ........... Eic

Authorization status:

unapproved drug other

Summary of Product characteristics

CONCEPT DHA- VITAMIN- MINERAL OMEGA-3 SUPPLEMENT CAPSULE, LIQUID
FILLED
U.S. 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 CONCEPT DHA
DESCRIPTION: Each capsule contains: Ferrous Fumarate (Elemental Iron)
. . . . . . . . . .
17.5 mg PolysaccharideIronComplex(ElementalIron).. 17.5mg
(Equivalent to about 35 mg of elemental iron) Vitamin C (from
ProAscorb C‡) . . .
. . . . . . . . . 25 mg FolicAcid.............................. 1mg
ThiamineMononitrate(B1) ................ 2mg Riboflavin(B2)
.......................... 3mg Niacin
(B3, from ProAscorb C‡) . . . . . . . . . . . . 1.8 mg d-
CalciumPantothenate(B5)................ 5mg PyridoxineHCI(B6)
.................... 25mg Biotin
(B7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 mcg
Cyanocobalamin(B12) ................
12.5mcg Copper(asCopperSulfate).................. 2mg
Magnesium(asMagnesiumSulfate) . . . . . . . .
Zinc(asZincSulfate).................... Omega-3
Fatty Acids . . . . . . . . . ...........
(Derived from 310 mg Fish Oil) Docosahexaenoic Acid (DHA) .
........... Eicosapentaenoic
Acid (EPA) . ........... . 5mg 10mg 200 mg156 mg 39 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 ab