TANDEM OB vitamin mineral supplement capsule
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
15-05-2018
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Active ingredient:
FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7)
Available from:
US Pharmaceutical Corporation
INN (International Name):
FERROUS FUMARATE
Composition:
FERROUS FUMARATE 162 mg
Prescription type:
PRESCRIPTION DRUG
Authorization status:
unapproved drug other
Summary of Product characteristics
TANDEM OB - VITAMIN MINERAL 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 OB
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
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