Vinacal

Generic Name: 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
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.

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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:51991-617-90 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 10/22/2009 08/31/2012
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Contract Pharmacal Corporation 057795122 MANUFACTURE
Revised: 01/2011
 
Breckenridge Pharmaceutical, Inc.
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