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PNV-Omega Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
85 mg, 200 IU, 10 IU, 25 mg, 1 mg, 12 mcg, 250 mcg, 140 mg, 28 mg, 150 mcg, 45 mg, 300 mg, 40 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - PNV-Omega

PNV - Omega

Rx Only

DESCRIPTION

PNV-Omega is a prescription prenatal/postnatal dietary supplement softgel capsule that contains multivitamins and minerals along with essential fatty acids. Each softgel is green in color, opaque and imprinted with “332” on one side.

OTHER INGREDIENTS

Beeswax, soy lecithin and vegetable shortening. Gelatin capsule (bovine gelatin, FD&C Blue #1, FD&C Yellow #5, FD&C Yellow #6, glycerin, purified water and titanium dioxide). Contains soy. Contains FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6.

INDICATIONS

PNV - Omega is a multivitamin/ multimineral dietary 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

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

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.

PRECAUTIONS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

HOW SUPPLIED

PNV - Omega is supplied in child-resistant bottles of 30 softgels (42192-332-30). 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.]

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

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

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please 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

L-0151 Rev. 0325-03

About this document

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

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Drug information for PNV-Omega

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, Osmotic Laxative, Phosphate Binder, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Ascorbic acid 85 mg, Cholecalciferol 200 IU, Alpha-tocopherol 10 IU, Pyridoxine hydrochloride 25 mg, Folic acid 1 mg, Cyanocobalamin 12 mcg, Biotin 250 mcg, Calcium carbonate 140 mg, Ferrous fumarate 28 mg, Potassium iodide 150 mcg, Magnesium oxide 45 mg, Doconexent 300 mg, Icosapent 40 mg
Dosage form Capsule, gelatin coated
Route Oral
Marketing status not in the current 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
85 mg, 200 IU, 10 IU, 25 mg, 1 mg, 12 mcg, 250 mcg, 140 mg, 28 mg, 150 mcg, 45 mg, 300 mg, 40 mg – 30 in 1 bottle NDC 42192-332-30

Source: FDA drug labeling via NLM DailyMed, data as of November 4, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.