Vinate

Dosage Form: tablet, chewable
Vinate® Care Chewables

Prenatal Vitamin and Mineral Supplement

Rx Only

Vinate Description

Each Vinate® Care Chewable Tablet Contains:

Vitamin C (1Ascorbic Acid and Threonic Acid) .........................................50 mg

Vitamin D3 (Cholecalciferol).......................................................................6 mcg

Vitamin E (as dl-Alpha Tocopheryl Acetate)............................................. 3.5 IU

Vitamin B6 (as Pyridoxine HCl)....................................................................2 mg

Folic Acid, USP..........................................................................................1 mg

Calcium (as Calcium Carbonate) .............................................................250 mg

Iron (as Ferrous Fumarate)........................................................................40 mg

Magnesium (as Magnesium Oxide, USP) ..................................................50 mg

Zinc (as Zinc Oxide, USP) .......................................................................15 mg

Copper (as Cupric Oxide) .........................................................................2 mg

Inactive Ingredients: Acacia, Carrageenan, Croscarmellose Sodium, Crospovidone, 2FD&C Yellow No. 6 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Orange Flavor, Polyvinylpyrrolidone, Silica, Starch, Stearic Acid, Sugar, Tartaric Acid, Unsaturated Mono & Diglycerides and Xylitol.

1

Vitamin C is provided as a blend of Calcium Ascorbate and Calcium Threonate.

2

This product contains FD&C Yellow No. 6 Lake as a color additive

Indications and Usage for Vinate

Vinate® Care Chewable tablets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period - for both lactating and non-lactating mothers. They are also useful for supplementing the nutritional status prior to conception.

Contraindications

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

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions

General

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

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Pediatric Use

Safety and effectiveness in the pediatric population, under 12, have not been established.

Geriatric Use

No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and/or concomitant diseases, or other drug therapy.

Adverse Reactions

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

Vinate Dosage and Administration

Usual dosage is one tablet daily, or as prescribed by a physician.

Do not exceed recommended dosage.

How is Vinate Supplied

Vinate® Care Chewable tablets are available as orange, round concave-shaped tablets, debossed B 576. Supplied in bottles of 30 tablets, NDC 51991-576-33.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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.

Manufactured by:

Contract Pharmacal Corp.

Hauppauge, NY 11788 USA

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Rx Only

Rev. 06/09

PRINCIPAL DISPLAY PANEL

Breckenridge

Pharmaceutical, Inc.

NDC 51991-576-33

Vinate® Care

Chewables

Prenatal Vitamin and

Mineral Supplement

Rx Only

30 Tablets

Vinate CARE  ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, calcium carbonate, ferrous fumurate, magnesium oxide, zinc oxide and cupric oxide  tablet, chewable

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-576 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 50 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 6 ug .alpha.-tocopherol acetate, dl- (.alpha.-tocopherol acetate, dl-) .alpha.-tocopherol acetate, dl- 3.5 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 2 mg Folic Acid (Folic Acid) Folic Acid 1 mg Calcium Carbonate (Calcium) Calcium Carbonate 250 mg Ferrous Fumarate (Iron) Ferrous Fumarate 40 mg Magnesium Oxide (MAGNESIUM CATION) MAGNESIUM CATION 50 mg Zinc Oxide (Zinc) Zinc Oxide 15 mg Cupric Oxide (Copper) Copper 2 mg

Inactive Ingredients Ingredient Name Strength Acacia   Carrageenan   Croscarmellose Sodium   Crospovidone   FD&C Yellow no. 6   Aluminum Oxide   Magnesium Stearate   Maltodextrin   Cellulose, Microcrystalline   Povidone K30   Silicon Dioxide   Stearic Acid   Raw Sugar   Tartaric Acid   Xylitol

Product Characteristics Color ORANGE (speckled) Score no score Shape ROUND Size 16mm Flavor ORANGE Imprint Code B576 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-576-33 30 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		03/01/2009	07/31/2012

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmacal Corporation		057795122	MANUFACTURE

Revised: 01/2011Breckenridge Pharmaceutical, Inc.

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