Natelle Complete

Dosage Form: capsule, gelatin coated
natelle® COMPLETE All-in-one Rx prenatal vitamin with plant-based DHA

Natelle Complete Description

Natelle® Complete capsules for oral administration are supplied as oblong pink soft gelatin capsules, imprinted with "nComplete" in white ink.

Each capsule contains:

Docosahexaenoic Acid (DHA) from Algal Oil.........................................................250 mg

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

Calcium (Tricalcium Phosphate).................................................................................100 mg

Iron (Ferrous Fumarate) .................................................................................................30 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

Vitamin D (Cholecalciferol) ........................................................................................... 400 IU

DHA is an omega-3 fatty acid. The DHA in Natelle® Complete is derived from Algal Oil (C. cohnii).

Inactive Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin, D&C Red #33, FD&C Red#40.

Indications and Usage for Natelle Complete

Natelle® Complete 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® Complete 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Other sources of folic acid are leafy vegetables, fortified cereals and bread. Causes of neural tube defect are multifactorial and folic acid supplements alone may not prevent these birth defects.

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 Complete Dosage and Administration

One capsule daily, or as directed by a physician.

How is Natelle Complete Supplied

Supplied in child resistant bottles of 30 capsules (NDC 18860-652-01).

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

NTCMw-10-01

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Physician Starter Kit Front Carton Label

Physician Starter Kit Front Carton Label

natelle® COMPLETE

All-in-one Rx prenatal vitamin with

plant-based DHA

A complete formulation for you and your baby.

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 Pharmelle.

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Physician Starter Kit Left-Side Carton Label

Physician Starter Kit Left-Side Carton Label

natelle® COMPLETE

All-in-one Rx prenatal vitamin with

plant-based DHA

NDA 18860-652-00

ONE PHYSICIAN SAMPLING KIT

Contains 10 Patient Starter Kits,

each containing 3 capsules

NOT FOR SALE

RX ONLY

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - Bottle Label

Bottle Label

30 CAPSULES

18860-652-01

Rx Only

natelle®

COMPLETE

All-in-one Rx prenatal vitamin with

plant-based DHA

Dist by: AZUR PHARMA, INC.

1818 Market Street, Suite 2350

Philadelphia, PA 19103

www.azurpharma.com

Mfg by: Accucaps Industries, Ltd.

Windsor, Ontario, Canada

To report a serious adverse event or obtain

product information, contact (800) 890 3098.

Natelle® is a registered trademark of Pharmelle.

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

Natelle Complete  docosahexaenoic acid, eicosapentaenoic acid, calcium, iron, vitamin c, vitamin b-6, vitamin e, folic acid and vitamin d  capsule, gelatin coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 18860-652 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 30 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 CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]

Inactive Ingredients Ingredient Name Strength GELATIN   GLYCERIN   SOYBEAN OIL   LECITHIN, SOYBEAN   TITANIUM DIOXIDE   ETHYL VANILLIN   YELLOW WAX   D&C RED NO. 33   FD&C RED NO. 40

Product Characteristics Color PINK Score no score Shape CAPSULE (oblong) Size 20mm Flavor Imprint Code nComplete Contains

Packaging # NDC Package Description Multilevel Packaging 1 18860-652-01 30 CAPSULE In 1 BOTTLE None 2 18860-652-00 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 3 CAPSULE In 1 BLISTER PACK This package is contained within the CARTON (18860-652-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/24/2011

Labeler - Azur Pharma, Inc. (805611071)

Establishment
Name	Address	ID/FEI	Operations
Accucaps Industries Limited		248441727	MANUFACTURE

Revised: 07/2011Azur Pharma, Inc.

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