PreNexa

Upsher-Smith Laboratories, Inc.

PreNexa Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• PRENEXA DESCRIPTION
• INDICATIONS
• PRENEXA CONTRAINDICATIONS
• WARNING
• PRECAUTION
• PRENEXA ADVERSE REACTIONS
• CAUTION
• PRENEXA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

Rx only

Rx Prenatal Vitamin with Plant-Based DHA from Algal Oil

• 1.25 mg Folic Acid and 300 mg DHA (key omega-3 fatty acid)
• Essential vitamins and minerals
• Gentle stool softener

PRENEXA DESCRIPTION

PreNexa ^® Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with plant-based DHA. Each softgel capsule is brown in color, opaque, and imprinted with "PreNexa".

Inactive Ingredients: Ethyl vanillin, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, palm kernel oil, sodium benzoate, soybean oil, sunflower oil, titanium dioxide, yellow beeswax, water and white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, simethicone, titanium dioxide).

Contains: Soy

INDICATIONS

PreNexa ^® Capsules are indicated to provide vitamin/mineral and plant-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PreNexa ^® may be useful in improving the nutritional status of women prior to conception.

PRENEXA CONTRAINDICATIONS

PreNexa ^® Capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

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.

PRECAUTION

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 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

PRENEXA 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 gram (1000 mg) per day.

PRENEXA DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.

HOW SUPPLIED

Bottles of 30 softgel capsules (NDC 0245-0178-30).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Upsher-Smith Laboratories, Inc. at 1-888-650-3789.

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.]

Distributed by:
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447
MADE IN CANADA

1-800-654-2299 www.upsher-smith.com
US Patents 5,407,957; 5,492,938. Other US Patents Pending.
© 2012 Upsher-Smith Laboratories, Inc.
104300-03

Revised 0811

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 0245-0178-30
Rx ONLY

DAILY-CAPSULE
PreNexa^®

Rx PRENATAL VITAMIN WITH PLANT-BASED DHA

ONCE-DAILY
DHA
FROM ALGAL OIL

ESSENTIAL VITAMINS,
MINERALS AND DHA
WITH A GENTLE
STOOL SOFTENER

30 SOFTGEL CAPSULES
UPSHER-SMITH