Label: PNV PRENATAL VITAMIN- .alpha.-tocopherol acetate, dl-, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, niacinamide, sodium ascorbate, ascorbic acid, pyridoxine hydrochloride, riboflavin, and thiamine mononitrate tablet, chewable
- NHRIC Code(s): 44946-1041-5
- Packager: Sancilio & Company Inc
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated December 27, 2017
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- STATEMENT OF IDENTITY
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STATEMENT OF IDENTITY
Each fruit-flavored PNV Chewable tablet contains:
VITAMINS: Vitamin C (as sodium ascorbate and ascorbic acid) 120 mg Vitamin D3 (as cholecalciferol) 400 IU Vitamin E (as dl-alpha tocopheryl acetate) 11 IU Vitamin B1 (as thiamin mononitrate) 2 mg Vitamin B2 (as riboflavin) 3 mg Vitamin B3 (as niacinamide) 20 mg Vitamin B6 (as pyridoxine HCL) 10 mg Vitamin Folic Acid 1 mg Vitamin B12 (as cyanocobalamin) 12 mcg MINERAL: Iron (as ferrous fumarate) 29 mg - DIRECTIONS
- CAUTION
- WARNING
- ADVERSE REACTIONS
- HOW SUPPLIED
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HEALTH CLAIM
This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the management of a dietary deficiency of folic acid and iron for which a distinctive nutritional requirement, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration or approval from the FDA.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.
Manufactured by: Sancilio & Company, Inc.,
Riviera Beach, FL 33404
(800) SCI-8711© 2011 Sancilio & Company, Inc.
REV: 12/06/11
- PRINCIPAL DISPLAY PANEL - 90 Tablets Bottle Label
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INGREDIENTS AND APPEARANCE
PNV PRENATAL VITAMIN
.alpha.-tocopherol acetate, dl-, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, niacinamide, sodium ascorbate, ascorbic acid, pyridoxine hydrochloride, riboflavin, and thiamine mononitrate tablet, chewableProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:44946-1041 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol, DL- - UNII:7QWA1RIO01) .Alpha.-Tocopherol, DL- 11 [iU] Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU] Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug Ferrous fumarate (UNII: R5L488RY0Q) (Ferrous cation - UNII:GW89581OWR) Ferrous cation 29 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 20 mg Sodium Ascorbate (UNII: S033EH8359) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine 10 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 3 mg Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 2 mg Inactive Ingredients Ingredient Name Strength Xylitol (UNII: VCQ006KQ1E) Microcrystalline Cellulose (UNII: OP1R32D61U) Malic Acid (UNII: 817L1N4CKP) Talc (UNII: 7SEV7J4R1U) Magnesium stearate (UNII: 70097M6I30) Sucralose (UNII: 96K6UQ3ZD4) Anhydrous Citric Acid (UNII: XF417D3PSL) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:44946-1041-5 90 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 12/20/2011 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 16 mm imprint flavor Labeler - Sancilio & Company Inc (176681257)