PRENATAL PLUS MULTIVITAMIN PLUS DHA MINICAPS- vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, niacinamide, and fish oil kit

Prenatal Plus Multivitamin Plus DHA MiniCaps by

Drug Labeling and Warnings

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

Drug Details [pdf]

STATEMENT OF IDENTITY

PRENATAL VITAMINS

Supplement Facts
Serving Size: 1 Tablet
Servings Per Container: 30
	Amount per serving	% Daily Value
OTHER INGREDIENTS: Croscarmellose Sodium, Microcrystalline Cellulose, Talc and Magnesium Stearate.
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; Folate	1 mg; 1700 mcg DFE	212%
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%

DHA* MINICAPS®

Supplement Facts
Serving Size: 1 MiniCap®
Servings Per Container: 30
	Amount per serving	% Daily Value
*Refers to Percent daily Value (%DV) based on a 2000 calorie diet.
*DHA as Ethyl Esters
†Daily Value not established.
OTHER INGREDIENTS: Fish Oil, Gelatin, Water, Glycerin, Orange Oil and Mixed Tocopherols.
Calories	5
Calories from Fat	5
Total Fat	0.4 g	3%
Saturated Fat	0 g	0%
Polyunsaturated Fat	<2 mg	†
Monounsaturated Fat	3 IU	†
Cholesterol	<2 mg	0%
Vitamin E	3 IU	10%
Total Omega-3 Fatty Acids	312 mg	†
DHA*(Docosahexaenoic Acid)	250 mg	†

HEALTH CLAIM

PNV Prenatal Plus Multivitamin tablets and DHA* MiniCaps® 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.‡

In addition, the vital fatty acids in DHA* support brain, eye and nervous system development of your unborn child.‡

Safe easy-to-swallow MiniCaps® have no fishy odor or aftertaste.

DOSAGE AND ADMINISTRATION

Before, during and after pregnancy, swallow 1 PNV Plus tablet and 1 DHA* MiniCap® SoftGel daily, 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 15º-30ºC (59º-86ºF). Protect from excess heat and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.

HEALTH CLAIM

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

LOT/EXP

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

REV 05/05/19
Manufactured in the USA

PRINCIPAL DISPLAY PANEL - Kit Carton

44946-2001-6

PNV Prenatal Health
PNV
Prenatal Vitamins

Prenatal Plus
MULTIVITAMIN
Tablets
+
DHA*
MINICAPS®

Dispense under a
physician's order†

Provides vitamin and
mineral supplementation
throughout pregnancy and
postnatal period‡

Dietary Supplement

Mercury Free
Sugar & Gluten Free

UNIT DOSE PACK
30 TABLETS AND 30 MINICAPS®

INGREDIENTS AND APPEARANCE

PRENATAL PLUS MULTIVITAMIN PLUS DHA MINICAPS 
vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, niacinamide, and fish oil kit

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:44946-2001

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:44946-2001-6	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	30
Part 2	1 BLISTER PACK	30

Part 1 of 2

PRENATAL PLUS MULTIVITAMIN 
vitamin a, ascorbic acid, cholecalciferol, tocopherol, thiamine mononitrate, riboflavin, pyridoxine, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide, and niacinamide tablet

Product Information
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
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	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 CARBONATE	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
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE (UNII: 029TFK992N)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		11/15/2016

Part 2 of 2

DHA MINICAPS 
fish oil capsule

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F)	FISH OIL	312 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ORANGE OIL (UNII: AKN3KSD11B)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		11/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		11/15/2016

Labeler - Agile RX (116742427)