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PNV Prenatal Vitamin Plus Vitamin A Package Insert

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
15 IU, 60 mg, 400 IU, 4.5 mcg, 1 mg, 27 mg, 50 mg, 13.5 mg, 1.05 mg, 1.2 mg, 1.05 mg, 2500 IU
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - PNV Prenatal Vitamin Plus Vitamin A

Each PNV tablet contains:

VITAMINS:
Vitamin A (as acetate)2500 IU
Vitamin C (as Ascorbic Acid)60 mg
Vitamin D3 (as Cholecalciferol)400 IU
Vitamin E (as Tocopheryl acetate)15 IU
Vitamin B1 (as Thiamine Mononitrate)1.05 mg
Vitamin B2 (as Riboflavin, USP)1.2 mg
Niacin (as Niacinamide)13.5 mg
Vitamin B6 (as Pyridoxine HCL)1.05 mg
Folic Acid1 mg
Vitamin B12 (as Cyanocobalamin)4.5 mcg
MINERAL:
Iron (as ferrous fumarate)27 mg
Calcium (as Dibasic Calcium Phosphate)50 mg

OTHER INGREDIENTS

Microcrystalline Cellulose, Croscarmellose Sodium, Citric Acid, Talc and Magnesium Stearate.

DIRECTIONS

One tablet daily with a meal, or as directed by a physician.

CAUTION

Folic acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

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.

ADVERSE REACTIONS

In some cases, allergic hypersensitivity has been reported following administration of folic acid. Mild gastrointestinal disturbances may occur with products containing ferrous fumarate (iron), but usually subside with continuation of therapy.

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.

This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the management of a dietary deficiency of folic acid and iron for which a distinctive nutritional requirement, based on recognized scientific principles, has been established by medical evaluation. 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 or approval from the FDA.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by: Sancilio & Company, Inc.,

Riviera Beach, FL 33404

(800) SCI-8711

© 2011 Sancilio & Company, Inc.

REV: 12/07/12

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: December 7, 2012

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Drug information for PNV Prenatal Vitamin Plus Vitamin A

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Alpha-Tocopherol acetate, DL- 15 IU, Ascorbic acid 60 mg, Cholecalciferol 400 IU, Cyanocobalamin 4.5 mcg, Folic acid 1 mg, Ferrous fumarate 27 mg, Calcium phosphate, dibasic, anhydrous 50 mg, Niacinamide 13.5 mg, Pyridoxine hydrochloride 1.05 mg, Riboflavin 1.2 mg, Thiamine mononitrate 1.05 mg, Vitamin A acetate 2500 IU
Dosage form Tablet
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Sancilio & Company Inc
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
15 IU, 60 mg, 400 IU, 4.5 mcg, 1 mg, 27 mg, 50 mg, 13.5 mg, 1.05 mg, 1.2 mg, 1.05 mg, 2500 IU – 30 in 1 bottle, plastic NDC 44946-1046-0
15 IU, 60 mg, 400 IU, 4.5 mcg, 1 mg, 27 mg, 50 mg, 13.5 mg, 1.05 mg, 1.2 mg, 1.05 mg, 2500 IU – 90 in 1 bottle, plastic NDC 44946-1046-2
15 IU, 60 mg, 400 IU, 4.5 mcg, 1 mg, 27 mg, 50 mg, 13.5 mg, 1.05 mg, 1.2 mg, 1.05 mg, 2500 IU – 400 in 1 bottle, plastic NDC 44946-1046-4

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.