FDA.reportPublic FDA data

PNV Prenatal Plus MULTIVITAMIN Tablets

Manufacturer
A-S Medication Solutions
Effective date
2017-10-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 20:24:41

Label at a glance#

ProductPNV Prenatal Plus Multivitamin
Active ingredientVITAMIN 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, CUPRIC OXIDE
Label structure9 sections

Boxed 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.

Storage and handling

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.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNING

BOXED WARNING SECTION

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

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.

STORAGE AND HANDLING SECTION

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.

SPL UNCLASSIFIED SECTION

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

REV: 04/11/13

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0617

NDC: 50090-0617-0 100 TABLET in a BOTTLE, PLASTIC

NDC: 50090-0617-1 30 TABLET in a BOTTLE

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128455200099876541299lbl500900617.jpg
Data codeData Matrix_1010005009006170217991231109987654_121AA000000lbl500900617.jpg

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0617-02020-01-31C16284748780-19d75b9d0-093d-f424-e053-dadaa90a57cePNV Prenatal Plus MULTIVITAMIN Tablets
50090-0617-12020-01-31C16284748780-19d75b9d0-093d-f424-e053-dadaa90a57cePNV Prenatal Plus MULTIVITAMIN Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0617-0PNV Prenatal Plus Multivitamin100 in 1 BOTTLE, PLASTICTABLET1009
50090-0617-1PNV Prenatal Plus Multivitamin30 in 1 BOTTLETABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0617PNV 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 [A-S MEDICATION SOLUTIONS]9Legacy NDC, 2 package rows20171023_a4d15311-9d6f-40d2-b48e-9cbc63ccc6a9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0617-0EA - Each50090-061767618b68-6f46-4921-b74c-bd03a09e66d012018-09-05
50090-0617-1EA - Each50090-0617bf7e4c7c-a8ee-4b9b-aba0-53b434bc383a12018-09-05
44946-1045-1EA - Each44946-10458c877d89-01c8-4ea1-85d9-77bd81c8a19f12013-06-04
44946-1045-4EA - Each44946-1045037aa8c5-66be-407b-9569-3c5fce50e7a412013-06-04
44946-1045-9EA - Each44946-1045573b173e-0e79-405c-8ac8-a5255b1e3b4912013-06-04

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-061750090-0617-0, 50090-0617-1
44946-1045

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A ACETATE3LE3D9D6OYACTIM
.BETA.-CAROTENE01YAE03M7JACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8ACTIM
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
CALCIUM CARBONATEH0G9379FGKACTIM
FERROUS FUMARATER5L488RY0QACTIM
ZINC OXIDESOI2LOH54ZACTIM
CUPRIC OXIDEV1XJQ704R4ACTIM
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT

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
26dd0268-08b8-445b-a631-cf5fa1bd7eb5a4d15311-9d6f-40d2-b48e-9cbc63ccc6a92017-10-23Boxed warningExact identifier
spl id: 26dd0268-08b8-445b-a631-cf5fa1bd7eb5
spl set id: a4d15311-9d6f-40d2-b48e-9cbc63ccc6a9

Reported adverse events (FAERS/openFDA)#

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