PRENATAL VITAMINS PLUS tablet

PreNatal Vitamins Plus by

Drug Labeling and Warnings

PreNatal Vitamins Plus by is a Prescription medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PreNatal Vitamins Plus
Rx Only

BOXED WARNING

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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.

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.

BOXED WARNING

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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

PRINCIPAL DISPLAY PANEL

Prenatal Plus

INGREDIENTS AND APPEARANCE

PRENATAL VITAMINS PLUS 
prenatal vitamins plus tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63629-3545(NDC: 64376-816)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	4000 [iU]
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	25 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.84 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	200 mg
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	2 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	27 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	20 mg
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	22 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ACACIA (UNII: 5C5403N26O)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBIC ACID (UNII: X045WJ989B)
SOY PROTEIN (UNII: R44IWB3RN5)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
DEXTROSE (UNII: IY9XDZ35W2)
METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63629-3545-1	100 in 1 BOTTLE
2	NDC: 63629-3545-2	30 in 1 BOTTLE
3	NDC: 63629-3545-3	90 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 - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-3545) , RELABEL(63629-3545)