Rx Prenatal Vitamin & Plant-Based DHA.
Now with 28 mg iron

BOXED WARNING

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) from Algal Oil..................................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. 250 mg of DHA from 625 mg of algal oil is derived from Crypthecodinium cohnii. DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination.

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

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.

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.

ADVERSE REACTIONS

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

DOSAGE and ADMINISTRATION

One capsule daily, or as directed by a physician.

HOW SUPPLIED

Supplied in child resistant bottles of 30 capsules (NDC 0037-6072-30).

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:
Meda Pharmaceuticals™
Somerset, New Jersey 08873-4120

© 2013 Meda Pharmaceuticals Inc.

NATELLE is a registered trademark and MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks of Meda AB or a related entity.

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

Rx Only

LB-607201-01

Rev. 10/2013

PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

30 CAPSULES    NDC 0037-6072-30

natelle®ONE

 

Rx Prenatal Vitamin &Plant-Based DHA.
Now with 28 mg Iron

Rx Only

 

Distributed by:
MEDA
PHARMACEUTICALS™
Somerset, New Jersey 08873-4120

© 2013 Meda Pharmaceuticals Inc.

 

To report SUSPECTED ADVERSE REACTIONS,
contact Meda Pharmaceuticals Inc. at
1-877-999-8405 or 1-800-FDA-1088 or
www.fda.gov/medwatch .

NATELLE is a registered trademark and MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks of Meda AB or a related entity.

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