PreNatal Vitamins Plus

Dosage Form: tablet
PreNatal Vitamins Plus

Rx Only

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 #5 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.

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

Coral Springs, FL 33065

www.bocapharmacal.com

1-800-354-8460

Iss. 02/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 64376-816-01

Bottle of 100 Tablets

[Rev 8]

PreNatal Vitamins Plus  PreNatal Vitamins Plus  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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) 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 ACETATE, 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. 5   FD&C YELLOW NO. 6   STARCH, CORN   SILICON DIOXIDE   SORBIC ACID   SOY PROTEIN   STEARIC ACID   SUCROSE   TITANIUM DIOXIDE   TRICALCIUM PHOSPHATE   HYPROMELLOSES   MAGNESIUM STEARATE   MALTODEXTRIN   GLYCERYL MONOSTEARATE   .ALPHA.-TOCOPHEROL, DL-

Product Characteristics Color WHITE (BEIGE) Score no score Shape OVAL (Caplet) Size 19mm Flavor Imprint Code BP;816 Contains

Packaging # NDC Package Description Multilevel Packaging 1 64376-816-01 100 TABLET In 1 BOTTLE None

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

Revised: 04/2011Boca Pharmacal, Inc.

More PreNatal Vitamins Plus resources

• PreNatal Vitamins Plus Use in Pregnancy & Breastfeeding
• Drug Images
• PreNatal Vitamins Plus Drug Interactions
• PreNatal Vitamins Plus Support Group
• 21 Reviews for PreNatal Vitamins Plus - Add your own review/rating

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