Medication Guide App

Natelle One

Generic Name: doconexent, icosapent, tricalcium phosphate, ferrous fumarate, ascorbic acid, pyridoxine hydrochloride, .alpha.-tocopherol and folic acid
Dosage Form: capsule, gelatin coated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Natelle® One
Rx Prenatal Vitamin & Plant-Based DHA
Now with 28 mg Iron

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.

Indications and Usage for Natelle One

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.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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.

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 is Natelle One 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.

Bottle Label

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.

Physicians Sample Kit

Natelle One 
doconexent,icosapent, tricalcium phosphate, ferrous fumarate, ascorbic acid, pyridoxine hydrochloride, alpha-tocopherol, and folic acid capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:18860-752
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 0.625 mg
TRICALCIUM PHOSPHATE (CALCIUM) TRICALCIUM PHOSPHATE 102 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE 28 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 30 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 30 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
SOYBEAN OIL  
LECITHIN, SOYBEAN  
TITANIUM DIOXIDE  
ETHYL VANILLIN  
YELLOW WAX  
Product Characteristics
Color RED Score no score
Shape CAPSULE (oblong) Size 25mm
Flavor Imprint Code Natelle1
Contains         
Packaging
# Item Code Package Description
1 NDC:18860-752-01 30 CAPSULE, GELATIN COATED in 1 BOTTLE
2 NDC:18860-752-00 3 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/11/2010
Labeler - Jazz Pharmaceuticals Commercial Corp. (805611071)
Revised: 06/2012
 
Jazz Pharmaceuticals Commercial Corp.
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