Medication Guide App

PreNatal Vitamins Plus

Generic Name: vitamin a, cholecalciferol, zinc, thiamine mononitrate, ascorbic acid, cyanocobalamin, calcium, copper, folic acid, iron, riboflavin, niacin, dl-alpha tocopherol acetate and pyridoxine
Dosage Form: tablet

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.

Unknown Title

PreNatal Vitamins Plus
Rx Only

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Each Tablet Contains: Amount per Tablet % Daily Value
Vitamin A (Acetate and Beta Carotene) 4000 I.U. 80%
Vitamin C (Ascorbic Acid) 120mg. 200%
Vitamin D-3 (Cholecalciferol) 400 I.U. 100%
Vitamin E (dl-Alpha Tocopheryl Acetate) 22 mg. 73%
Vitamin B-1 (Thiamine Mononitrate) 1.84 mg. 123%
Vitamin B-2 (Riboflavin) 3 mg. 176%
Niacin (Niacinamide) 20 mg 100%
Vitamin B-6 (Pyridoxine HCl) 10 mg. 500%
Folic Acid 1 mg. 200%
Vitamin B-12 (Cyanocobalamin) 12 mcg. 200%
Calcium (from Calcium Carbonate) 200 mg. 20%
Iron (Ferrous Fumarate) 27 mg. 150%
Zinc (Zinc Oxide) 25 mg. 167%
Copper (Cupric Oxide) 2 mg. 100%

Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL-alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono- and di-glycerides, Polyethylene Glycol, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.

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Indications: To provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.

Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.

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

Caution: Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six.  Keep this product out of reach of children.  In case of accidental overdose, call a physician or Poison Control Center immediately.

Store at room temperature, USP. Dispense in a well closed light resistant container. KEEP OUT OF THE REACH OF CHILDREN.

Manufactured for: Boca Pharmacal, Inc., Coral Springs, FL 33065
www.bocapharmacal.com    1-800-354-8460   Iss. 06/12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64376-816-01
Bottle of 100 Tablets

[Rev 10]

NDC 64376-816-05
Bottle of 500 Tablets

[Rev 7]

PreNatal Vitamins Plus 
PreNatal Vitamins Plus tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64376-816
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A (VITAMIN A) VITAMIN A 4000 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ZINC (ZINC) ZINC 25 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 1.84 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM (CALCIUM) CALCIUM 200 mg
COPPER (COPPER) COPPER 2 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
IRON (IRON) IRON 27 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACIN (NIACIN) NIACIN 20 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 22 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL  
POLYETHYLENE GLYCOLS  
ASCORBYL PALMITATE  
ANHYDROUS CITRIC ACID  
CELLULOSE, MICROCRYSTALLINE  
ACACIA  
ETHYLCELLULOSES  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
STARCH, CORN  
SILICON DIOXIDE  
SORBIC ACID  
SOY PROTEIN  
STEARIC ACID  
SUCROSE  
TITANIUM DIOXIDE  
TRICALCIUM PHOSPHATE  
HYPROMELLOSES  
MAGNESIUM STEARATE  
MALTODEXTRIN  
.ALPHA.-TOCOPHEROL, DL-  
DEXTROSE  
METHYLCELLULOSE (15 CPS)  
GLYCERYL MONOSTEARATE  
Product Characteristics
Color WHITE (BEIGE) Score no score
Shape OVAL (Caplet) Size 19mm
Flavor Imprint Code BP;816
Contains         
Packaging
# Item Code Package Description
1 NDC:64376-816-01 100 TABLET (TABLET) in 1 BOTTLE
2 NDC:64376-816-05 500 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/15/2011
Labeler - Boca Pharmacal, Inc. (170266089)
Registrant - Boca Pharmacal, Inc. (170266089)
Establishment
Name Address ID/FEI Operations
Cispharma Inc. 833171445 MANUFACTURE(64376-816)
Revised: 08/2012
 
Boca Pharmacal, Inc.



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