Label: PNV PRENATAL PLUS MULTIVITAMIN- 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, and cupric oxide tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 50090-0617-0, 50090-0617-1 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 44946-1045
- 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 October 23, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
DESCRIPTION
Each PNV Tablet Contains: Amount Per Serving Vitamin A (from 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 mg Vitamin B-1 (from Thiamine Mononitrate) 1.84 mg Vitamin B-2 (Riboflavin) 3 mg Niacin (as Niacinamide) 20 mg Vitamin B-6 (from Pyridoxine HCl) 10 mg Folic Acid 1 mg Vitamin B-12 (Cyanocobalamin) 12 mcg MINERALS: 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, Microcrystalline Cellulose, Talc, Magnesium Stearate.
- Indications
- Dosage
- BOXED WARNING (What is this?)
- Precautions
-
STORAGE AND HANDLING
STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F). AVOID EXCESS HEAT. Dispense in a well closed light-resistant container, with a child resistant cap.
This medical food product is formulated to be administered orally, under the supervision of a physician.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- 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, and
-
INGREDIENTS AND APPEARANCE
PNV PRENATAL PLUS MULTIVITAMIN
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, and cupric oxide tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0617(NDC:44946-1045) 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 2000 [iU] .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 2000 [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 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 CATION - UNII:13S1S8SF37) ZINC CATION 25 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color YELLOW (Off-white speckled) Score no score Shape OVAL Size 19mm Flavor Imprint Code SCI7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-0617-0 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/28/2014 2 NDC:50090-0617-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 04/01/2013 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0617)
