PNV-Omega

PNV-Omega is an FDA-registered drug product whose active ingredient is ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT. It is labelled by Acella Pharmaceuticals, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 42192-332, label effective 20260722. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT are most often described in connection with: indications pnv, omega multivitamin, multimineral dietary, supplement indicated, management patients, nutritional deficiencies. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

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

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.

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

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is PNV-Omega used for?
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.

Who makes PNV-Omega?
Acella Pharmaceuticals, LLC is the labeler of record for PNV-Omega.

What form does PNV-Omega come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is PNV-Omega prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has PNV-Omega been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.