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 
Bryant Ranch Prepack

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.

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PNV Prenatal Plus MULTIVITAMIN Tablets

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 Acid1 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

To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.

Dosage

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 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 mask the symptoms of hematological damage due to Vitamin B12 deficiency of pernicious anemia while the associated neurological damage progresses.

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.

Manufactured by:
Sancilio & Company, Inc.
3874 Fiscal Court
Riviera Beach, FL 33404
(800)SCI-8711

REV: 04/11/13

HOW SUPPLIED

Product: 71335-0440

NDC: 71335-0440-3 90 TABLET in a BOTTLE

NDC: 71335-0440-1 100 TABLET in a BOTTLE

NDC: 71335-0440-2 30 TABLET in a BOTTLE

Prenatal Plus Tablet

Label Image
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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-0440(NDC:44946-1045)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2000 [iU]
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE2000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [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) THIAMINE1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorYELLOW (Off-white speckled) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code SCI7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0440-390 in 1 BOTTLE; Type 0: Not a Combination Product07/21/201405/09/2022
2NDC:71335-0440-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/21/201405/09/2022
3NDC:71335-0440-230 in 1 BOTTLE; Type 0: Not a Combination Product07/21/201405/09/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/01/201305/09/2022
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0440) , RELABEL(71335-0440)

Revised: 5/2022
 
Bryant Ranch Prepack