PNV-DHA

Acella Pharmaceuticals, LLC

PNV-DHA

FULL PRESCRIBING INFORMATION: CONTENTS*

• PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets

FULL PRESCRIBING INFORMATION

Rx Only

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.

Supplement Facts
Serving Size 1 Tablet
Amount Per Serving		% DV	%DV for Pregnant or Lactating Women
Vitamin C	85 mg	142%	142%
Vitamin D3	200 IU	50%	50%
Vitamin E	10 IU	33%	33%
Vitamin D6	25 mg	1250%	1000%
Folate	1 mg	250%	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 B12	12 mcg	200%	150%
Calcium	140 mg	14%	11%
Iron (ferrous fumarate)	27 mg	150%	150%
Magnesium	45 mg	11%	10%
Docosahexaenoic Acid (DHA) (from omega-3 fatty acids)	300 mg	Daily Value (DV) not established	Daily Value (DV) not established

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

Uses

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: 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.

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: 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-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.]

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

PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets

NDC 42192-321-30

PNV-DHA

Rx Prenatal Vitamin and DHA

Rx Only           30 Softgels

Acella
PHARMACEUTICALS, LLC