PRENATE AM- .pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)

Available from:

Avion Pharmaceuticals, LLC

INN (International Name):

PYRIDOXINE HYDROCHLORIDE

Composition:

PYRIDOXINE HYDROCHLORIDE 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DESCRIPTION: PRENATE ® AM is a yellow, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "Prenate" on one side and "AM" on the other.

Authorization status:

unapproved drug other

Summary of Product characteristics

PRENATE AM- .PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM
CARBONATE AND FOLIC
ACID TABLET, COATED
AVION PHARMACEUTICALS, 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._
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_PRENATE AM_
_DIETARY SUPPLEMENT _
_RX PRENATAL VITAMIN WITH B VITAMINS AND GINGER _
_WITH _
QUATREFOLIC
RX ONLY
DESCRIPTION: PRENATE
AM is a yellow, oval, oil- and water-soluble,
multivitamin/multimineral, film-coated tablet debossed with "Prenate"
on one side and "AM" on the
other.
SUPPLEMENT FACTS
Serving Size: 1 Tablet
EACH TABLET CONTAINS:
Vitamin B6 (Pyridoxine Hydrochloride)
75 mg
Vitamin B12 (Cyanocobalamin)
12 mcg
Calcium (as Calcium Carbonate)
200 mg
Folate (as 1.1 mg Quatrefolic® ((6S)-
5,methyltetrahydrofolate glucosamine salt* CAS
1181972-37-1) molar equivalent to 600 mcg of
Folic Acid) (folic acid, USP 400 mcg)
1 mg
Ginger Extract
500 mg
Lingonberry
25 mg
OTHER INGREDIENTS: Methocel K, stearic acid, magnesium stearate and
silicon dioxide,
dicalcium phosphate
PRECAUTIONS: Concomitant use of ginger in patients with bleeding
disorders, or who are on
anti-coagulant or anti-platelet therapy, may increase the risk of
bleeding. Folic acid alone is
improper therapy in the treatment of pernicious anemia and other
megaloblastic anemias where
Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may
obscure pernicious anemia
in that hematologic remission can occur while neurological
manifestations progress. While
prescribing this nutritional supplement for pregnant women, nursing
mothers or for women prior
to conception, their medical condition and any drugs, herbs and/or
supplements consumption
should be considered.
DOSAGE AND ADMINISTRATION: One tablet daily or as directed by your
doctor.
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG
ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE
OR PREVENT ANY DISEASE.
Store at 20° - 25°C (68° - 77°