Pnv-dha Capsule, Gelatin Coated
FDA Label NDC 42192-321

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acella Pharmaceuticals, Llc for the product Pnv-dha (NDC 42192-321). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, description, inactive ingredient, indications & usage, contraindications, warnings, boxed warning, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Rx Only

Supplement Facts
Serving Size 1 Tablet
Amount Per
Serving 		% DV %DV for Pregnant
or Lactating
Women
Vitamin C85 mg142%142%
Vitamin D 3200 IU50%50%
Vitamin E10 IU33%33%
Vitamin D 625 mg1250%1000%
Folate1 mg250%125%
(L-methylfolate calcium 676 mcg (as Xolafin-B™

Percent Daily Values are based on a 2000 calorie diet

)
molar equivalent to 600 mcg of Folic Acid)
(folic acid, USP 400 mcg)
Vitamin B 1212 mcg200%150%
Calcium140 mg14%11%
Iron (ferrous fumarate)27 mg150%150%
Magnesium45 mg11%10%
Docosahexaenoic Acid (DHA)
(from omega-3 fatty acids) 		300 mg

Daily Value (DV) not established

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 active ingredients, excipients, inactive ingredients and chemical information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802
Rev. 04/10v6

*Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC

Description

DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque and imprinted with “BP 321” on one side.

Inactive Ingredient

OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3.

Indications & Usage

INDICATIONS: PNV-DHA 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

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

Warnings

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.

Boxed Warning

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

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

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

Dosage & Administration

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

How Supplied

HOW SUPPLIED: PNV-DHA is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30).

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

Principal Display Panel - 30 Softgel Tablets

NDC 42192-321-30

PNV-DHA

Rx Prenatal Vitamin and DHA

Rx Only           30 Softgels

Acella
PHARMACEUTICALS, LLC

Principal Display Panel (Film Coated Tablets)

Principal Display Panel (Film Coated Tablets)

* Please review the disclaimer below.