Label: PRENATAL VITAMINS PLUS tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 63629-3545-1, 63629-3545-2, 63629-3545-3 - Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 64376-816
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated July 17, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- BOXED WARNING (What is this?)
-
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.
- BOXED WARNING (What is this?)
-
Manufactured for: Boca Pharmacal, Inc., Coral Springs, FL 33065
www.bocapharmacal.com 1-800-354-8460 Iss. 06/12 - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PRENATAL VITAMINS PLUS
prenatal vitamins plus tabletProduct 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)
