VINATE AZ - beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, magnesium oxide, zinc oxide and cupric oxide tablet, film coated 
Breckenridge Pharmaceutical, Inc.

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VINATE® AZ Tablets

Rx Only

Description

Vinate® AZ tablets are light pink, film-coated, oval shaped tablets that are intended for oral administration.

Each Tablet Contains:
Vitamin A (Beta-Carotene)	3000 I.U.
Vitamin C (Ascorbic Acid)	120 mg
Vitamin D3 (Cholecalciferol)	400 I.U.
Vitamin E (dl-Alpha Tocopheryl Acetate)	30 I.U.
Vitamin B1 (Thiamine Hydrochloride)	3 mg
Vitamin B2 (Riboflavin)	3.5 mg
Niacin (Niacinamide)	20 mg
Vitamin B6 (Pyridoxine Hydrochloride)	30 mg
Folic Acid	1 mg
Vitamin B12 (Cyanocobalamin)	12 mcg
Biotin	30 mcg
Pantothenic Acid (d-Calcium Pantothenate)	8 mg
Calcium (Calcium Carbonate)	150 mg
Iron (Ferrous Bis-Glycinate Chelate)	27 mg
Magnesium (Magnesium Oxide)	75 mg
Zinc (Zinc Oxide)	15 mg
Copper (Cupric Oxide)	2.5 mg

INACTIVE INGREDIENTS: Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Dicalcium Phosphate, Maltodextrin, Cornstarch, Glucose, dl-Alpha Tocopherol, Sodium Ascorbate, Hypromellose, Gum Acacia.

Coating: Titanium Dioxide, Polydextrose, Hypromellose, Triacetin, Polyethylene Glycol, FD&C Red No. 40 Aluminum Lake, 1FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, Sodium Carboxymethylcellulose, Maltodextrin, Dextrose Monohydrate, Lecithin, Ethyl Cellulose, Hydroxypropyl Cellulose, Purified Water.

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1

Contains FD&C Yellow No. 6 as a color additive.

ALLERGEN INFORMATION

This product contains soy.

INDICATIONS

Vinate® AZ tablets are indicated for providing adequate nutritional support for women before, during and after pregnancy.

CONTRAINDICATIONS

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

WARNINGS

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this and all medications out of reach of children. In case of an accidental overdose, seek professional assistance, or contact a poison control center immediately.

PRECAUTIONS

Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

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. For use only under the supervision of a licensed physician.

HOW SUPPLIED

Vinate® AZ Tablets are light pink, film-coated oval-shaped tablets available for oral administration. Each tablet is debossed "B 466" on one side and plain on the other side. Available in bottles of 90 tablets. NDC 51991-466-90.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from light and moisture.

Dispense in a tight, light-resistant container with a child-resistant closure, as defined in the USP/NF.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx Only

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Manufactured by:
Nexgen Pharma, Inc. Irvine, CA 92614

7048
Rev 2/07

PRINCIPAL DISPLAY PANEL - 90 Tablets Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-466-90

Vinate®AZ

Prenatal Vitamin and
Mineral Supplement

Rx ONLY

90 TABLETS

VINATE AZ  beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, magnesium oxide, zinc oxide and cupric oxide   tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-466 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Beta Carotene (Vitamin A) Vitamin A 3000 [iU] Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 120 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU] ALPHA-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL ACETATE, DL-) ALPHA-TOCOPHEROL ACETATE, DL- 30 [iU] Thiamine Hydrochloride (Thiamine) Thiamine 3 mg Riboflavin (Riboflavin) Riboflavin 3.5 mg Niacinamide (Niacin ) Niacin 20 mg Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 30 mg Folic Acid (Folic Acid) Folic Acid 1 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug Biotin (Biotin) Biotin 30 ug Calcium Pantothenate (Pantothenic Acid) Pantothenic Acid 8 mg Calcium Carbonate (Calcium) Calcium 150 mg Iron (Iron) Iron 27 mg Magnesium Oxide (MAGNESIUM CATION) MAGNESIUM CATION 75 mg Zinc Oxide (Zinc) Zinc 15 mg Cupric Oxide (Copper) Copper 2.5 mg

Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline   Croscarmellose Sodium   Stearic Acid   Silicon Dioxide   Magnesium Stearate   Anhydrous Dibasic Calcium Phosphate   Maltodextrin   starch, corn   Alpha-Tocopherol, dl-   Sodium Ascorbate   Hypromellose   Acacia   Titanium Dioxide   Polydextrose   Triacetin   Polyethylene Glycol   FD&C Red no. 40   FD&C Yellow no. 6   FD&C Blue no. 2   Aluminum Oxide   Carboxymethylcellulose Sodium   Dextrose Monohydrate   Hydroxypropyl Cellulose   Water

Product Characteristics Color PINK Score no score Shape OVAL Size 19mm Flavor Imprint Code B466 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-466-90 90 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		02/01/2007

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Nexgen Pharma		057795122	MANUFACTURE

Revised: 10/2009Breckenridge Pharmaceutical, Inc.