Natelle One

Jazz Pharmaceuticals Commercial Corp.

Natelle OneRx Prenatal Vitamin & Plant-Based DHA Now with 28 mg Iron

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/MEDICATIONS OUT OF THE REACH OF CHILDREN.
• Principal Display Panel - Bottle
• Principal Display Panel - Physician Sample Kit

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).......................................................102 mg

Iron (Ferrous Fumarate) ......................................................................28 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 Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to 250 mg of DHA.

Inactive 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 DHA 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 0.1 mg 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

Supplied in child resistant bottles of 30 capsules (NDC 18860-752-01).

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).

KEEP THIS AND ALL DRUGS/MEDICATIONS 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 Azur Pharma International II Limited.

Rx Only

NAT1w-11-01

Principal Display Panel - Bottle

30 Capsules

NDC 18860-752-01

Natelle^® ONE

Rx Prenatal Vitamin & Plant-Based DHA.

Now with 28 mg Iron

Rx Only

Dist by: AZUR PHARMA INC.

1818 Market Street, Suite 2350

Philadelphia, PA 19103

www.azurpharma.com

Mfg by: Accucaps Industries Ltd

Windsor, Ontario, Canada

Natelle^® is a registered trademark of Azur Pharma International II Limited.

Principal Display Panel - Physician Sample Kit

Natelle^® ONE

Rx Prenatal Vitamin & Plant-Based DHA

NDC 18860-752-00

ONE PHYSICIAN SAMPLING KIT

Contains 10 Patient Starter Kits, each containing 3 capsules

NOT FOR SALE

RX ONLY

Distributed by: AZUR PHARMA, INC.
1818 Market Street, Suite 2350 · Philadelphia, PA 19103 · www.azurpharma.com

Manufactured by: Accucaps Industries Ltd. Windsor, Ontario, Canada

Natelle^® is a registered trademark of Azur Pharma International II Limited.

life'sDHA^™ is a trademark of Market Biosciences Corporation.