Label: PRENATAL PLUS IRON- multivitamin/multimineral supplement tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 10544-609-31 - Packager: Blenheim Pharmacal, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5339
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 12, 2016
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DESCRIPTION
Prenatal Plus Iron Tablet is caplet shaped, film coated tablet debossed CIS 28, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.
Each Prenatal Plus tablet Contains:
Vitamin A (Acetate and Beta Carotene)............................................4000 I.U.
Vitamin C (Ascorbic acid)..................................................................120 mg
Vitamin D-3 (Cholecalciferol)...............................................................400 I.U.
Vitamin E (dl- Alpha Tocopheryl Acetate)...........................................22 I.U.
Thiamine (Vitamin B-1 from Thiamine Mononitrate...............................1.84 mg
Riboflavin (Vitamin B-2).......................................................................3 mg
Niacin(Niacinamide).............................................................................20 mg
Vitamin B-6 (Pyridoxine HCl)...............................................................10 mg
Folic Acid.............................................................................................1 mg
Vitamin B-12 (Cyanocobalamin)..........................................................12 mcg
Calcium (Calcium Carbonate)...............................................................200 mg
Iron (Carbonyl Iron)..............................................................................29 mg
Zinc (Zinc Oxide).................................................................................25 mg
Copper (Cupric Oxide)..........................................................................2 mg
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 Yello # 6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono-and di-glycerides, Polyethyelene Glycol, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate
- INDICATIONS
- DOSAGE
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BOXED WARNING
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WARNING
Warning: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Precautions: Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progesses.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yello No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
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INGREDIENTS AND APPEARANCE
PRENATAL PLUS IRON
multivitamin/multimineral supplement tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-609(NDC:0904-5339) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 3080 [iU] .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 920 [iU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 22 [iU] THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J) THIAMINE 1.84 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 10 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 29 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ASCORBYL PALMITATE (UNII: QN83US2B0N) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) ACACIA (UNII: 5C5403N26O) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364) LIGHT MINERAL OIL (UNII: N6K5787QVP) CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) METHYL SORBATE (UNII: J3048615R1) SOY PROTEIN (UNII: R44IWB3RN5) Product Characteristics Color YELLOW (TAN) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code CIS28 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10544-609-31 31 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/17/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/17/2010 Labeler - Blenheim Pharmacal, Inc. (171434587) Registrant - Blenheim Pharmacal, Inc. (171434587) Establishment Name Address ID/FEI Business Operations Blenheim Pharmacal, Inc. 171434587 repack(10544-609)
