Natelle Complete Prescribing Information
Package insert / product label
Generic name: doconexent, icosapent, tricalcium phosphate, ferrous fumarate, ascorbic acid, pyridoxine hydrochloride, alpha-tocopherol, folic acid and cholecalciferol
Dosage form: capsule, gelatin coated
Drug classes: Iron products, Vitamin and mineral combinations
Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.
On This Page
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.
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.
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/Side Effects
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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 |
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| Labeler - Azur Pharma, Inc. (805611071) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Accucaps Industries Limited | 248441727 | MANUFACTURE | |
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