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.
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.
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.
Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.
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.
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.
STARTER KIT LABEL
natelle one capsule, gelatin coated
HUMAN PRESCRIPTION DRUG
Item Code (Source)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
HYDROGENATED SOYBEAN OIL
5 CAPSULE, GELATIN COATED ( CAPSULE) in 1 BLISTER PACK