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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

BOXED WARNING

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.

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) from Algal Oil..................................250 mg

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

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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.

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.

 

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

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 is Natelle One 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.

Natelle One 
doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acid capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-6072
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
CALCIUM (CALCIUM) CALCIUM 102 mg
IRON (IRON) IRON 28 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 30 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 mg
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 30 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
YELLOW WAX  
GLYCERIN  
SOYBEAN OIL  
LECITHIN, SOYBEAN  
TITANIUM DIOXIDE  
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code natelle1
Contains         
Packaging
# Item Code Package Description
1 NDC:0037-6072-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/01/2015
Labeler - MEDA Pharmaceuticals (051229602)
Revised: 05/2015
 
MEDA Pharmaceuticals
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