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Prenate Chewable

Generic Name: calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, botin and bilberry
Dosage Form: tablet, chewable

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 chewable

A chewable Rx prenatal vitamin with a delicious chocolate flavor
With

Quatrefolic®

Rx Only

DESCRIPTION: Prenate Chewable is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with "Prenate Chew" on one side and blank on the other.

Supplement Facts
Serving Size: 1 Tablet
Amount per Serving: % Daily Value
Calcium (as calcium carbonate) 500 mg
Vitamin D3 300 IU
Magnesium (as magnesium oxide) 50 mg
Boron Amino Acid Chelate 250 mcg
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
Vitamin B6 (as pyridoxine HCL) 10 mg
Vitamin B12 (as Cyanocobalamin) 125 mcg
Biotin 280 mcg
Blueberry Extract 25 mg

OTHER INGREDIENTS: Natural Dutch Chocolate, Fructose, Gum Acacia, Magnesium Stearate, Silicon Dioxide, Chocolate Flavor

INDICATIONS: Prenate Chewable is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Prenate Chewable can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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

PRECAUTIONS: 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.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

HOW SUPPLIED: Prenate Chewable is supplied in child-resistant bottles of 30 tablets (75854-306-30).

The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

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.

MANUFACTURED FOR: Avion Pharmaceuticals, LLC
Atlanta, GA 30350
1-888-61-AVION

*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 Chewable is a trademark of Avion Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

Rev. 0113

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-306-30

Prenate chewable

A chewable Rx prenatal vitamin with a delicious chocolate flavor

with
Quatrefolic®

30 Tablets

Rx Only

Avion
PHARMACEUTICALS

Prenate Chewable 
calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-306
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 500 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 300 [iU]
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 50 mg
BORON (BORON) BORON 250 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 125 mg
BIOTIN (BIOTIN) BIOTIN 280 ug
BILBERRY (BILBERRY) BILBERRY 25 mg
Inactive Ingredients
Ingredient Name Strength
FRUCTOSE  
ACACIA  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color BROWN Score 2 pieces
Shape ROUND Size 22mm
Flavor CHOCOLATE Imprint Code PrenateChew
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-306-30 30 TABLET, CHEWABLE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/16/2013
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 08/2013
 
Avion Pharmaceuticals, LLC



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