PNV-DHA
PNV-DHA is an FDA drug label for the active ingredient ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT manufactured by Acella Pharmaceuticals, LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260723.
- Generic name
- ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT
- Manufacturer
- Acella Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 42192-321
- Application
- N/A
- Label effective
- 20260723
About this product
PNV-DHA is an FDA-registered drug product whose active ingredient is ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT. It is labelled by Acella Pharmaceuticals, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 42192-321, label effective 20260723. 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.
What it is used for
Across FDA labelling, products containing ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT are most often described in connection with: indications pnv-dha, multivitamin multimineral, fatty acid, dietary supplement, nutritional status, women throughout, postnatal period, nonlactating mothers. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Indications & Usage
INDICATIONS: PNV-DHA is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
Contraindications
CONTRAINDICATIONS: PNV-DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Adverse Reactions
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Recall and safety notices
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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0523-2026 | NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16 | Acella Pharmaceuticals, LLC | Class II | Ongoing | 20260513 |
| D-0014-2026 | Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. | Acella Pharmaceuticals, LLC | Class II | Ongoing | 20251015 |
| D-0490-2024 | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06 | Acella Pharmaceuticals, LLC | Class III | Terminated | 20240515 |
| D-0074-2023 | Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60 | Acella Pharmaceuticals, LLC | Class III | Terminated | 20221207 |
| D-0070-2023 | Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 | Acella Pharmaceuticals, LLC | Class III | Terminated | 20221130 |
Frequently asked questions
What is PNV-DHA used for?
INDICATIONS: PNV-DHA is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.
Who makes PNV-DHA?
Acella Pharmaceuticals, LLC is the labeler of record for PNV-DHA.
What form does PNV-DHA 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-DHA 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-DHA 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.