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PNV-Select Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
2500 IU, 80 mg, 400 IU, 10 IU, 3 mg, 3.4 mg, 20 mg, 20 mg, 1 mg, 12 mcg, 300 mcg, 6 mg, 120 mg, 27 mg, 150 mcg, 30 mcg, 15 mcg, 2 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - PNV-Select

Rx Only

DESCRIPTION: PNV-Select is a prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of a white, oval, oil-and water-soluble, film-coated tablet debossed with “320” on one side.

OTHER INGREDIENTS: Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).

INDICATIONS: PNV-Select is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

HOW SUPPLIED: PNV-Select is supplied in child-resistant bottles of 90 tablets (42192-320-90). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein.

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.

MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30005

1-800-541-4802

Rev 0719-03

About this document

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

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Drug information for PNV-Select

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, Calculi Dissolution Agent, Copper Absorption Inhibitor, Osmotic Laxative, Phosphate Binder, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A acetate 2500 IU, Ascorbic acid 80 mg, Cholecalciferol 400 IU, Alpha-tocopherol acetate, DL- 10 IU, Thiamine mononitrate 3 mg, Riboflavin 3.4 mg, Niacinamide 20 mg, Pyridoxine hydrochloride 20 mg, Folic acid 1 mg, Cyanocobalamin 12 mcg, Biotin 300 mcg, Calcium pantothenate 6 mg, Calcium carbonate 120 mg, Ferrous fumarate 27 mg, Potassium iodide 150 mcg, Magnesium oxide 30 mcg, Zinc oxide 15 mcg, Cupric oxide 2 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) Acella Pharmaceuticals, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
2500 IU, 80 mg, 400 IU, 10 IU, 3 mg, 3.4 mg, 20 mg, 20 mg, 1 mg, 12 mcg, 300 mcg, 6 mg, 120 mg, 27 mg, 150 mcg, 30 mcg, 15 mcg, 2 mg – 90 in 1 bottle NDC 42192-320-90

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.