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PNV Prenatal Plus Multivitamin Package Insert

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
2000 IU, 2000 IU, 120 mg, 400 IU, 22 mg, 1.84 mg, 3 mg, 20 mg, 10 mg, 1 mg, 12 mcg, 200 mg, 27 mg, 25 mg, 2 mg

Prescribing information (package insert) - PNV Prenatal Plus Multivitamin

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

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

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

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.

Precautions

Folic Acid may mask the symptoms of hematological damage due to Vitamin B12 deficiency of pernicious anemia while the associated neurological damage progresses.

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.

Manufactured by:

Sancilio & Company, Inc.

3874 Fiscal Court

Riviera Beach, FL 33404

(800)SCI-8711

REV: 04/11/13

HOW SUPPLIED

Product: 50090-0617

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

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

About this document

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

Revision date stated in the text: April 11, 2013

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Drug information for PNV Prenatal Plus Multivitamin

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 Blood Coagulation Factor, Copper Absorption Inhibitor, Phosphate Binder, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A acetate 2000 IU, Beta-carotene 2000 IU, Ascorbic acid 120 mg, Cholecalciferol 400 IU, Alpha-tocopherol acetate, DL- 22 mg, Thiamine mononitrate 1.84 mg, Riboflavin 3 mg, Niacinamide 20 mg, Pyridoxine hydrochloride 10 mg, Folic acid 1 mg, Cyanocobalamin 12 mcg, Calcium carbonate 200 mg, Ferrous fumarate 27 mg, Zinc oxide 25 mg, Cupric oxide 2 mg
Dosage form Tablet
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) A-S Medication Solutions
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Packages (NDC)
Package
2000 IU, 2000 IU, 120 mg, 400 IU, 22 mg, 1.84 mg, 3 mg, 20 mg, 10 mg, 1 mg, 12 mcg, 200 mg, 27 mg, 25 mg, 2 mg – 100 in 1 bottle, plastic NDC 50090-0617-0
2000 IU, 2000 IU, 120 mg, 400 IU, 22 mg, 1.84 mg, 3 mg, 20 mg, 10 mg, 1 mg, 12 mcg, 200 mg, 27 mg, 25 mg, 2 mg – 30 in 1 bottle NDC 50090-0617-1

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.