FDA.reportPublic FDA data

Prenatal Plus Multivitamin Plus DHA MiniCaps

Manufacturer
Agile RX
Effective date
2023-11-07
Label type
DIETARY SUPPLEMENT
Version
7
Source
full-release
Hydrated at
2026-06-01 02:50:54

Label at a glance#

ProductPrenatal Plus Multivitamin Plus DHA MiniCaps
Active ingredientVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE, NIACINAMIDE, FISH OIL
Label structure11 sections

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.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

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 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 Acid
Folate		1 mg
1700 mcg DFE		212%
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%
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.
Calories5
  Calories from Fat5
Total Fat0.4 g3%
  Saturated Fat0 g0%
  Polyunsaturated Fat<2 mg†
  Monounsaturated Fat3 IU†
Cholesterol<2 mg0%
Vitamin E3 IU10%
Total Omega-3 Fatty Acids312 mg†
DHA*(Docosahexaenoic Acid)250 mg†

HEALTH CLAIM SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

WARNINGS SECTION

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

PRECAUTIONS SECTION

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

SAFE HANDLING WARNING SECTION

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 SECTION

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

HEALTH CLAIM SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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®

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
cd2aa2bf-3a9a-4fb3-9436-a62d0a299fa7Product name120230823
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-2001-6Prenatal Plus Multivitamin Plus DHA MiniCaps1 in 1 CARTONKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-2001PRENATAL 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 [AGILE RX]71 package rows20231108_6749570e-d93b-482f-b7e8-80f8a65a55fc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-2001-6EA - Each44946-200176b9923e-70ab-4132-8f72-f85bc810717d12017-03-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44946-200144946-2001-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A ACETATE3LE3D9D6OYACTIM
.BETA.-CAROTENE01YAE03M7JACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8ACTIM
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
FERROUS FUMARATER5L488RY0QACTIM
ZINC OXIDESOI2LOH54ZACTIM
CUPRIC OXIDEV1XJQ704R4ACTIM
NIACINAMIDE25X51I8RD4ACTIB
CROSCARMELLOSE029TFK992NIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
FISH OILXGF7L72M0FACTIB
GELATIN, UNSPECIFIED2G86QN327LIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ORANGE OILAKN3KSD11BIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
08b804fd-d859-48a1-86a4-c6ff19e5563e6749570e-d93b-482f-b7e8-80f8a65a55fc2018-04-04Boxed warningExact identifier
spl set id: 6749570e-d93b-482f-b7e8-80f8a65a55fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.