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Prenate AM

Avion Pharmaceuticals, LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

DISTRIBUTED BY:
Avion Pharmaceuticals, LLC
Atlanta, GA 30350 1-888-61-AVION            Rev. 0513

The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

*Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

PRENATE® AM is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-307-30

Prenate® Am
Dietary Supplement
Rx prenatal vitamin with B vitamins and Ginger
With

Quatrefolic®

PRENATE® AM’s formulation eases symptoms
commonly associated with pregnancy, including
nausea and vomiting.

30 Tablets
Rx Only

Avion
PHARMACEUTICALS

Prenate AM

Prenate AM

.pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid TABLET, COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:75854-307
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 75 mg
Cyanocobalamin CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE 200 mg
FOLIC ACID FOLIC ACID 1 mg

Inactive Ingredients

Ingredient Name Strength
GINGER
LINGONBERRY
HYPROMELLOSES
STEARIC ACID
MAGNESIUM STEARATE
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

Product Characteristics

Color Size Imprint Code Shape
YELLOW 22 mm Prenate;AM OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:75854-307-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-06-15


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Be sure to consult your doctor before taking any medication!
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