Vinacal

Dosage Form: tablet, film coated
Vinacal™

Prenatal Tablets

Each Vinacal™ tablet contains:

Vitamin C (as Ascorbic Acid)...........................................................120 mg

Vitamin D3 (Cholecalciferol) .............................................................400 IU

Vitamin E (as dl-Alpha Tocopheryl Acetate).......................................30 IU

Vitamin B1 (as Thiamine Mononitrate) ................................................3 mg

Vitamin B2 (Riboflavin) .....................................................................3.4 mg

Niacinamide (Vitamin B3) ..................................................................20 mg

Vitamin B6 (as Pyridoxine HCl) .........................................................20 mg

Folic Acid ............................................................................................1 mg

Calcium (as Calcium Citrate) ..........................................................125 mg

Iron (as Carbonyl Iron and Ferrous Gluconate) ................................27 mg

Iodine (as Potassium Iodide).........................................................150 mcg

Zinc (as Zinc Oxide) ..........................................................................25 mg

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

Docusate Sodium .............................................................................50 mg

Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Gelatin, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Ascorbate, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbic Acid, Soy Polysaccharide, Starch, Stearic Acid, Sucrose, Titanium Dioxide, Triacetin, Triglycerides and Tocopherols.

Allergen: Contains Soy

INDICATIONS

Vinacal™ Tablets are a multivitamin/multimineral tablet, for use in supplementing the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

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.

Warning

Keep this and all medications out of the reach of children.

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.

NOTICE

Contact with moisture can produce surface discoloration or erosion of the tablet.

Precautions

Folic acid in doses above 0.1 mg 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.

Warning

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

Vinacal Dosage and Administration

Adults only

One tablet daily, or as directed by a physician.

Contraindications

All iron compounds are contraindicated in patients with hemochromatosis and hemosiderosis. This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

How is Vinacal Supplied

Vinacal™ Tablets are available as a scored, white film-coated, oval shaped tablet debossed B 617 on one side and blank on the other. Supplied in bottles of 90, NDC 51991-617-90.

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.

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Manufactured by:

Contract Pharmacal Corp.

Hauppauge, NY 11788 USA

Iss. 08/09

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle

Breckenridge

Pharmaceutical, Inc.

NDC 51991-617-90

Vinacal™

Prenatal Tablets

DO NOT USE IF SAFETY SEAL UNDER THE CAP

IS BROKEN OR MISSING

Rx Only

90 TABLETS

Vinacal  docusate sodium, ascorbic acid, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cholecalciferol, calcium citrate, iron, potassium iodide, zinc oxide, and cupric oxide  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-617 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Docusate Sodium (Docusate) Docusate 50 mg Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 120 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 30 [iU] Thiamine Mononitrate (Thiamine) Thiamine 3 mg Riboflavin (Riboflavin) Riboflavin 3.4 mg Niacinamide (Niacin) Niacin 20 mg Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 20 mg Folic Acid (Folic Acid) Folic Acid 1 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU] Calcium Citrate (Calcium) Calcium 125 mg Iron (Iron) Iron 27 mg Potassium Iodide (Iodine) Iodine 150 ug Zinc Oxide (Zinc) Zinc 25 mg Cupric Oxide (Copper) Copper 2 mg

Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate   Croscarmellose Sodium   Crospovidone   Anhydrous Dibasic Calcium Phosphate   Gelatin   Hypromelloses   Magnesium Silicate   Magnesium Stearate   Cellulose, Microcrystalline   Mineral Oil   Povidone K30   Silicon Dioxide   Sodium Ascorbate   Sodium Benzoate   Sodium Lauryl Sulfate   Sorbic Acid   Stearic Acid   Sucrose   Titanium Dioxide   Triacetin   ALPHA-TOCOPHEROL

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 9mm Flavor Imprint Code B;617 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-617-90 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		10/22/2009	08/31/2012

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

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

Revised: 01/2011Breckenridge Pharmaceutical, Inc.

More Vinacal resources

• Vinacal Use in Pregnancy & Breastfeeding
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