Dosage Form: capsule, gelatin coated
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 | ||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 06/11/2010 | ||
| Labeler - Azur Pharma, Inc. (805611071) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Accucaps Industries Limited | 248441727 | MANUFACTURE | |
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