Natelle One

Azur Pharma, Inc.

Natelle®OneRx Prenatal Vitamin & Plant-Based DHA

FULL PRESCRIBING INFORMATION: CONTENTS*

• NATELLE ONE DESCRIPTION
• NATELLE ONE INDICATIONS AND USAGE
• NATELLE ONE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Pediatric Use
  • Geriatric Use
• NATELLE ONE ADVERSE REACTIONS
• NATELLE ONE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
• BOTTLE LABEL
• STARTER KIT LABEL

FULL PRESCRIBING INFORMATION

NATELLE ONE DESCRIPTION

Natelle® One capsules for oral administration are supplied as oblong red soft gelatin capsules, imprinted with "Natelle1" in white ink.

Each capsule contains:

Docosahexaenoic Acid (DHA) .....................................................250 mg

Eicosapentaenoic Acid (EPA).......................................................Not more than 0.625mg

Calcium (Tricalcium Phosphate)...................................................100 mg

Iron (Ferrous Fumarate) ..................................................................27 mg

Vitamin C (Ascorbic Acid) .............................................................30 mg

Vitamin B-6 (Pyridoxine HCl) ........................................................25 mg

Vitamin E (D-Alpha Tocopherol) ....................................................30 IU

Folic Acid ...........................................................................................1 mg

DHA is an omega-3 fatty acid. The DHA in Natelle® One is derived from the oils of microalgae.

Other Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin.

NATELLE ONE INDICATIONS AND USAGE

Natelle® One is indicated to provide vitamin/mineral and omega–3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non–lactating mothers, and throughout the childbearing years. Natelle® One may be beneficial in improving the nutritional status of women prior to conception.

NATELLE ONE CONTRAINDICATIONS

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

WARNINGS

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

PRECAUTIONS

Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.

NATELLE ONE ADVERSE REACTIONS

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

NATELLE ONE DOSAGE AND ADMINISTRATION

One capsule daily, or as directed by a physician.

HOW SUPPLIED

Natelle® One capsules for oral administration are supplied as oblong red soft gelatin capsules, imprinted with "Natelle1" in white ink, in bottles of 30 capsules (NDC 18860-852-01).

Store at controlled room temperature 15°-30°C (59°-86°F).

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

Distributed by: Azur Pharma, Inc. • 1818 Market Street, Suite 2350 • Philadelphia, PA 19103 • www.azurpharma.com

To report a serious adverse event or obtain product information, contact (800) 890 3098.

life’sDHA™ is a trademark of Martek Biosciences Corporation.

Natelle® is a registered trademark of Pharmelle.

Rx Only

NAT1-09-01

BOTTLE LABEL