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

PNV Prenatal Plus Multivitamin by

Drug Labeling and Warnings

PNV Prenatal Plus Multivitamin by is a Other medication manufactured, distributed, or labeled by Agile RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Serving Size: 1 Tablet Servings Per Container: 100
	Amount per serving	% Daily Value
Vitamin A (from Acetate and Beta Carotene)	4000 IU	50%
Vitamin C (Ascorbic Acid)	120 mg	200%
Vitamin D-3 (Cholecalciferol)	400 IU	100%
Vitamin E (dl-Alpha Tocopheryl Acetate)	22 mg	50%
Vitamin B-1 (from Thiamine Mononitrate)	1.84 mg	108%
Vitamin B-2 (Riboflavin)	3 mg	150%
Niacin (as Niacinamide)	20 mg	100%
Vitamin B-6 (from Pyridoxine HCl)	10 mg	400%
Folic Acid	1 mg	125%
Vitamin B-12 (Cyanocobalamin)	12 mcg	150%
Calcium (as Calcium Carbonate)	200 mg	15%
Iron (from Ferrous Fumarate)	27 mg	150%
Zinc (from Zinc Oxide)	25 mg	167%
Copper (from Cupric Oxide)	2 mg	100%

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

HEALTH CLAIM

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.

WARNINGS

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.

SAFE HANDLING WARNING

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

HEALTH CLAIM

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.

HEALTH CLAIM

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

Made in the USA

LOT/EXP
REV 05/02/19

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

44946-1045-1

PNV Prenatal Health
PNV
Prenatal Vitamins

Prenatal Plus
MULTIVITAMIN
Tablets

Dispense under a
physician's order†

Provides vitamin and
mineral supplementation
throughout pregnancy and
postnatal period‡

Dietary Supplement

Sugar & Gluten Free

100
TABLETS

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 tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC: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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:44946-1045-1	100 in 1 BOTTLE, PLASTIC
2	NHRIC:44946-1045-4	30 in 1 BOTTLE, PLASTIC
3	NHRIC:44946-1045-9	500 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		04/01/2013

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	19 mm
imprint

Labeler - Agile RX (116742427)