Label: PRENATAL PLUS- vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 65162-668-10, 65162-668-50 - Packager: Amneal Pharmaceuticals LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 29, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
Each Tablet Contains:
VITAMINS: Amount per Tablet
Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU
Vitamin C (Ascorbic Acid) ........................................................... 120 mg
Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU
Vitamin E (dl- Alpha Tocopheryl Acetate) ...................................... 22 mg
Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.84 mg
Riboflavin (Vitamin B-2) .................................................................. 3 mg
Niacin (as Niacinamide) ................................................................ 20 mg
Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg
Folic Acid ......................................................................................... 1 mg
Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg
MINERALS: Amount per Tablet
Calcium (as Calcium Carbonate) ................................................. 200 mg
Iron (from Ferrous Fumarate) ........................................................ 27 mg
Zinc (from Zinc Oxide) ................................................................... 25 mg
Copper (from Cupric Oxide) ........................................................... 2 mg
Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide
- INDICATIONS AND USAGE
- WARNINGS
- PRECAUTIONS
- DOSAGE AND ADMINISTRATION
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HOW SUPPLIED
Bottles of 100: NDC 65162-668-10
Bottles of 500: NDC 65162-668-50
Storage
STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF), AVOID EXCESS HEAT.
Dispense in a well closed light-resistant container, with a child resistant cap.
KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.
DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.Manufactured by:
Nexgen Pharma
Colorado Springs, CO 80905Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141Rev. 09-2012
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRENATAL PLUS
vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-668 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 mg 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 HYDROCHLORIDE 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 FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 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 ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM ASCORBATE (UNII: S033EH8359) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBIC ACID (UNII: X045WJ989B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) SUNFLOWER OIL (UNII: 3W1JG795YI) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color yellow Score no score Shape OVAL Size 19mm Flavor Imprint Code G12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65162-668-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/02/2009 2 NDC:65162-668-50 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/02/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/02/2009 Labeler - Amneal Pharmaceuticals LLC (123797875) Establishment Name Address ID/FEI Business Operations New Generation Wellness 806784679 analysis(65162-668) , manufacture(65162-668)
