VINATE® AZ 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 
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 Acid1 mg
Vitamin B12 (Cyanocobalamin)12 mcg
Biotin30 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.


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

Principal Display Panel - 90 Tablets Label

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 TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51991-466
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Beta Carotene (Vitamin A) Vitamin A3000 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid120 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol400 [iU]
ALPHA-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL ACETATE, DL-) ALPHA-TOCOPHEROL ACETATE, DL-30 [iU]
Thiamine Hydrochloride (Thiamine) Thiamine3 mg
Riboflavin (Riboflavin) Riboflavin3.5 mg
Niacinamide (Niacin ) Niacin 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine30 mg
Folic Acid (Folic Acid) Folic Acid1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin12 ug
Biotin (Biotin) Biotin30 ug
Calcium Pantothenate (Pantothenic Acid) Pantothenic Acid8 mg
Calcium Carbonate (Calcium) Calcium150 mg
Iron (Iron) Iron27 mg
Magnesium Oxide (MAGNESIUM CATION) MAGNESIUM CATION75 mg
Zinc Oxide (Zinc) Zinc15 mg
Cupric Oxide (Copper) Copper2.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScore no score
ShapeOVALSize19mm
FlavorImprint Code B466
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-466-9090 TABLET In 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/01/2007

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIOperations
Nexgen Pharma057795122MANUFACTURE
Revised: 10/2009Breckenridge Pharmaceutical, Inc.