Advertisement

Topics

natelleONE | Natelle One [MEDA Pharmaceuticals] | BioPortfolio

13:08 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Rx Prenatal Vitamin & Plant-Based DHA. Now with 28 mg iron

BOXED WARNING

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.

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) from Algal Oil..................................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. 250 mg of DHA from 625 mg of algal oil is derived from Crypthecodinium cohnii. DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination.

Inactive Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin.

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.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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 0.1 mg 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.

 

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8405 or 1-800-FDA-1088 or www.fda.gov/medwatch.

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

One capsule daily, or as directed by a physician.

Supplied in child resistant bottles of 30 capsules (NDC 0037-6072-30).

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: Meda Pharmaceuticals™ Somerset, New Jersey 08873-4120

© 2013 Meda Pharmaceuticals Inc.

NATELLE is a registered trademark and MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks of Meda AB or a related entity.

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

Rx Only

LB-607201-01

Rev. 10/2013

30 CAPSULES    NDC 0037-6072-30

natelleONE

Rx Prenatal Vitamin &Plant-Based DHA. Now with 28 mg Iron

Rx Only

Distributed by: MEDA PHARMACEUTICALS™ Somerset, New Jersey 08873-4120

© 2013 Meda Pharmaceuticals Inc.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8405 or 1-800-FDA-1088 or www.fda.gov/medwatch.

NATELLE is a registered trademark and MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks of Meda AB or a related entity.

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

Manufacturer

Meda Pharmaceuticals Inc.

Active Ingredients

Source

Drugs and Medications [1 Associated Drugs and Medications listed on BioPortfolio]

Natelle one [azur pharma, inc.]

Natelle®OneRx Prenatal Vitamin & Plant-Based DHA

Clinical Trials [0 Results]

None

PubMed Articles [0 Results]

None

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record