Vinate AZ

Generic Name: multi-vitamins and minerals
Dosage Form: tablet, film-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.

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.

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.

Vinate AZ Dosage and Administration

One tablet daily or as directed by a physician. For use only under the supervision of a licensed physician.

How is Vinate AZ 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 LABEL Item Code (Source) NDC: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  
Hypromelloses  
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
# Item Code Package Description
1 NDC:51991-466-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/01/2007 06/30/2012
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma 057795122 MANUFACTURE
Revised: 01/2011
 
Breckenridge Pharmaceutical, Inc.
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