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Name:Natelle One
Manufacturer:Azur Pharma, Inc.
Category:Prescription Marketed Drugs


Natelle®OneRx Prenatal Vitamin & Plant-Based DHA

NATELLE ONE  - doconexent, icosapent, tricalcium phosphate, ferrous fumarate, ascorbic acid, pyridoxine hydrochloride, alpha-tocopherol, d- and folic acid capsule, gelatin coated 
Azur Pharma, Inc.

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.

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Natelle®One
Rx Prenatal Vitamin & Plant-Based DHA

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.

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.

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.
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 0.1mg 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.

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

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

Natelle One Bottle Label

STARTER KIT LABEL

Natelle One Starter Kit Label

NATELLE ONE 
natelle one capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:18860-852
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 100 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE 27 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 30 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
ALPHA-TOCOPHEROL, D- (ALPHA-TOCOPHEROL, D-) ALPHA-TOCOPHEROL, D- 30 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
WAX, YELLOW  
HYDROGENATED SOYBEAN OIL  
LECITHIN, SOYBEAN  
TITANIUM DIOXIDE  
ETHYL VANILLIN  
Product Characteristics
Color red Score no score
Shape CAPSULE (oblong) Size 25mm
Flavor Imprint Code Natelle;1
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:18860-852-00 5 CAPSULE, GELATIN COATED ( CAPSULE) in 1 BLISTER PACK None
2 NDC:18860-852-01 30 CAPSULE, GELATIN COATED ( CAPSULE) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other na 11/09/2009

Labeler - Azur Pharma, Inc. (805611071)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Limited 248441727 manufacture

Revised: 10/2009 Azur Pharma, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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