alpha-tocopherol acetate, dl-,
zinc oxide and
cupric oxide tablet, film coated
Breckenridge Pharmaceutical, Inc.
----------VINATE® AZ Tablets
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|
|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.
This product contains soy.
Vinate® AZ tablets are indicated for providing adequate nutritional support for women before, during and after pregnancy.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
One tablet daily or as directed by a physician. For use only under the supervision of a licensed physician.
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.
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.
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
Nexgen Pharma, Inc. Irvine, CA 92614
Prenatal Vitamin and
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
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Unapproved drug other||02/01/2007|
|Labeler - Breckenridge Pharmaceutical, Inc. (150554335)|