Your browser does not support JavaScript! PRENATAL VITAMINS PLUS TABLET [BOCA PHARMACAL, INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

Out of scope

PRENATAL VITAMINS PLUS tablet
[Boca Pharmacal, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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 mg100%
Vitamin B-6 (Pyridoxine HCl)10 mg.500%
Folic Acid1 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.

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
adba00af-figure-01

[Rev 10]

NDC 64376-816-05
Bottle of 500 Tablets
adba00af-figure-02

[Rev 7]

PRENATAL VITAMINS PLUS 
prenatal vitamins plus tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64376-816
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (VITAMIN A) VITAMIN A4000 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL400 [iU]
ZINC (ZINC) ZINC25 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE1.84 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID120 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN12 ug
CALCIUM (CALCIUM) CALCIUM200 mg
COPPER (COPPER) COPPER2 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
IRON (IRON) IRON27 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN3 mg
NIACIN (NIACIN) NIACIN20 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL-22 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (BEIGE) Scoreno score
ShapeOVAL (Caplet) Size19mm
FlavorImprint Code BP;816
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64376-816-01100 in 1 BOTTLE
2NDC:64376-816-05500 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/15/2011
Labeler - Boca Pharmacal, Inc. (170266089)
Registrant - Boca Pharmacal, Inc. (170266089)
Establishment
NameAddressID/FEIBusiness Operations
Cispharma Inc.833171445MANUFACTURE(64376-816)

Revised: 8/2012
 
Boca Pharmacal, Inc.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services