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.

----------

PNV Prenatal Plus MULTIVITAMIN Tablets

Supplement Facts
Serving Size: 1 Tablet
Servings Per Container: 100
Amount per serving% Daily Value
Vitamin A (from Acetate and Beta Carotene)4000 IU50%
Vitamin C (Ascorbic Acid)120 mg200%
Vitamin D-3 (Cholecalciferol)400 IU100%
Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg50%
Vitamin B-1 (from Thiamine Mononitrate)1.84 mg108%
Vitamin B-2 (Riboflavin)3 mg150%
Niacin (as Niacinamide)20 mg100%
Vitamin B-6 (from Pyridoxine HCl)10 mg400%
Folic Acid1 mg125%
Vitamin B-12 (Cyanocobalamin)12 mcg150%
Calcium (as Calcium Carbonate)200 mg15%
Iron (from Ferrous Fumarate)27 mg150%
Zinc (from Zinc Oxide)25 mg167%
Copper (from Cupric Oxide)2 mg100%

OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Talc, Magnesium Stearate.

PNV Prenatal Plus Multivitamin tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period, for both lactating and non-lactating mothers, and are useful for improving nutritional status prior to conception.‡

DIRECTIONS

One tablet daily with a meal, or as directed by a physician.

TAMPER EVIDENT FEATURE

Do not use if inner-seal beneath cap is missing or broken.

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.

CAUTION

Folic Acid may mask the symptoms of hematological damage due to Vitamin B12 deficiency of pernicious anemia while the associated neurological damage progresses.

Other Information

To report a serious adverse event or obtain product information, call 1-888-750-5290. Store at controlled room temperature 15°-30°C (59°-86°F). Protect from excess heat and moisture. Dispense in a tight, light-resistant container with child-resistant closure.

IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222.

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 with the FDA.

The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

Manufactured for:
Agile RX LLC
Boynton Beach, FL 33437
(888) 750-5290

Made in the USA

LOT/EXP
REV 05/02/19

HOW SUPPLIED

NDC: 63629-6973-1: 100 Tablets in a BOTTLE, PLASTIC

NDC: 63629-6973-2: 90 Tablets in a BOTTLE, PLASTIC

NDC: 63629-6973-3: 30 Tablets in a BOTTLE, PLASTIC

340B PRENATAL PLUS TABLET

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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-6973(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:63629-6973-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/201603/03/2022
2NDC:63629-6973-290 in 1 BOTTLE; Type 0: Not a Combination Product04/14/201603/03/2022
3NDC:63629-6973-330 in 1 BOTTLE; Type 0: Not a Combination Product10/31/201603/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/201303/03/2022
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-6973) , RELABEL(63629-6973)

Revised: 3/2022
 
Bryant Ranch Prepack