Prenate Essential: Package Insert / Prescribing Info

DESCRIPTION: PRENATE ESSENTIAL ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with "Prenate" on one side and blank on the other.

PRENATE ESSENTIAL ® contains fish oil and soy.

INDICATIONS: PRENATE ESSENTIAL ® 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.

PRENATE ESSENTIAL ® can also be beneficial in improving the nutritional status of women prior to conception

CONTRAINDICATIONS: PRENATE ESSENTIAL ® 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 B 12 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: Bottles of 30 softgels (75854-313-30).

The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

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

MANUFACTURED FOR: Avion Pharmaceuticals, LLC

Atlanta, GA 30005

1-888-61-AVION

Rev. 0519-01

Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.

Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-313-30

PRENATE ESSENTIAL ®

Rx prenatal vitamin & DHA

• Key vitamins, minerals, and DHA support nutrition

GLUTEN FREE

Rx Only

Dietary Supplement

30 Softgels