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Pnv-dha Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
28 mg, 160 mg, 27 mg, 400 IU, 30 IU, 25 mg, 1.25 mg, 300 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - Pnv-dha

Rx Only

DESCRIPTION

PNV-DHA + Docusate is a prescription prenatal/postnatal multivitamin/multimineral softgel with DHA. Each softgel is red in color and imprinted with “323” on one side.

† Daily Value (DV) not established.
SUPPLEMENT FACTS
Serving Size: 1 softgel

Amount Per

Serving

% Daily

Value

Vitamin C (as ascorbic acid, USP)28 mg47%
Calcium (tribasic calcium phosphate, NF)160 mg16%
Iron (as ferrous fumarate, USP)27 mg150%
Vitamin D 3(as cholecalciferol, USP)400 IU100%
Vitamin E (as d-alpha-tocopherol acetate, USP)30 IU100%
Vitamin B 6(as pyridoxine HCl, USP)25 mg1250%
Folic Acid, USP1.25 mg313%
DHA (docosahexaenoic acid)300 mg†
Docusate sodium, USP55 mg†

OTHER INGREDIENTS

Bovine Gelatin, Glycerin, Soybean Oil, Soy Lecithin, Purified Water, Yellow Beeswax, FD&C Red # 40, Titanium Dioxide, Orange Cream Flavor, Ethyl Vanillin, FD&C Yellow # 6, and FD&C Blue #1. Contains soy.

INDICATIONS

PNV-DHA + Docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

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 12is 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.

CAUTION:Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 grams (1000 mg) daily.

DOSAGE AND ADMINISTRATION

Usual adult dose is one (1) softgel daily or as directed by a physician.

KEEP OUT OF REACH OF CHILDREN.

HOW SUPPLIED

PNV-DHA + Docusate is supplied in child-resistant bottles of 30 softgels (42192-323-30). The listed product number 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”]. Protect from light and heat.

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 30022

1-800-541-4802

Rev. 0717-01

About this document

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

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Drug information for Pnv-dha

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 Calcium, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Ascorbic acid 28 mg, Calcium 160 mg, Ferrous fumarate 27 mg, Cholecalciferol 400 IU, Alpha-tocopherol acetate, DL- 30 IU, Pyridoxine 25 mg, Folic acid 1.25 mg, Doconexent 300 mg
Dosage form Capsule, gelatin 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
28 mg, 160 mg, 27 mg, 400 IU, 30 IU, 25 mg, 1.25 mg, 300 mg – 30 in 1 bottle NDC 42192-323-30

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.