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Prenate AM

Generic Name: pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid
Dosage Form: tablet, coated

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.

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°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 
.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) PYRIDOXINE HYDROCHLORIDE 75 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
GINGER 500 mg
LINGONBERRY 25 mg
HYPROMELLOSES  
STEARIC ACID  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 22mm
Flavor Imprint Code Prenate;AM
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-307-30 30 TABLET, COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/15/2013
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 06/2013
 
Avion Pharmaceuticals, LLC



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