PNV Prenatal Plus MULTIVITAMIN Tablets

Manufacturer
Bryant Ranch Prepack
Effective date
2017-12-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:04:22

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: 71335-0440

NDC: 71335-0440-3 90 TABLET in a BOTTLE

NDC: 71335-0440-1 100 TABLET in a BOTTLE

NDC: 71335-0440-2 30 TABLET in a BOTTLE

Prenatal Plus Tablet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
71335-044071335-0440-3, 71335-0440-1, 71335-0440-2
44946-1045

Ingredients#

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

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

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
d52bb489-387d-4ba5-b9a4-371b02fd479143acf2cd-bc8e-4fed-8efc-3bec6450ea802022-05-09Boxed warningExact identifier
spl set id: 43acf2cd-bc8e-4fed-8efc-3bec6450ea80

Reported adverse events (FAERS/openFDA)#

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