BIFERARX- folic acid, heme iron polypeptide, iron dextran, and cyanocobalamin tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), Heme Iron Polypeptide (UNII: 31VDO12CJY) (Heme Iron Polypeptide - UNII:31VDO12CJY), IRON DEXTRAN (UNII: 95HR524N2M) (IRON DEXTRAN - UNII:95HR524N2M), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Commercializzato da:

Alaven Pharmaceutical LLC

INN (Nome Internazionale):

FOLIC ACID

Composizione:

FOLIC ACID 1 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

BiferaRx™ is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency. This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

Dettagli prodotto:

BiferaRx™ tablets are supplied in child-resistant bottles of 90 tablets (NDC 68220-085-90) and as a Professional Sample 5 tablet blister pack (NDC 68220-085-25). KEEP OUT OF REACH OF CHILDREN. Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See current USP] Dispense in a tight, light-resistant container to protect from light and moisture.

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

BIFERARX- FOLIC ACID, HEME IRON POLYPEPTIDE, IRON DEXTRAN, AND
CYANOCOBALAMIN TABLET
ALAVEN PHARMACEUTICAL LLC
_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._
----------
BIFERA RX™
IRON SUPPLEMENT TABLETS
RX ONLY
DESCRIPTION
BiferaRx™ is a prescription iron supplement. BiferaRx™ is a small
oval, film-coated maroon tablet,
with black core, debossed and bisected with "AP|85" on one side, and
plain on the other.
EACH BIFERARX™ TABLET CONTAINS:
VITAMINS
AMOUNT PER SERVING
Folic Acid
1 mg
B12 (as cyanocobalamin)
25 mcg
MINERALS
*
Iron
as PIC (polysaccharide iron
complex)
22 mg
as HIP (heme iron polypeptide as
Proferrin
- bovine source,
USDA certified)
6 mg
INACTIVE INGREDIENTS
Microcrystalline cellulose, croscarmellose sodium, crospovidone,
magnesium stearate, silicon
dioxide, coating (polyvinyl alcohol, polyethylene glycol, talc, FD&C
red no. 40 aluminum lake, titanium
dioxide, FD&C blue no. 2 aluminum lake).
INDICATIONS AND USAGE
BiferaRx™ is a prescription iron supplement indicated for use in
improving the nutritional status of iron
deficiency.
CONTRAINDICATIONS
This product is contraindicated in patients with a known
hypersensitivity to any of the ingredients.
Proferrin
is a registered trademark of Colorado
Biolabs, Inc. Cozad, NE.
BiferaRx™ is a trademark of Alaven
Pharmaceutical
LLC, Marietta, GA.
®
®
®*
Hemochromatosis and hemosiderosis are contraindications to iron
therapy.
WARNING
Accidental overdose of iron-containing products is a leading cause of
fatal poisoning in children
under 6.
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental
overdose, call a doctor or
poison control center immediately.
PRECAUTIONS
Folic acid when administered as a single agent in doses above 0.1mg
daily may obscure pernicious
anemia in that hematological remission can occur while neurological
manifestations remain
progressive. While prescribing this nutritional suppl