Natelle One by MEDA Pharmaceuticals natelle®ONE
Natelle One by
Drug Labeling and Warnings
Natelle One by is a Prescription medication manufactured, distributed, or labeled by MEDA Pharmaceuticals. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
NATELLE ONE- doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acid capsule, gelatin coated
Meda Pharmaceuticals
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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natelle®ONE
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.
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) 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.
INDICATIONS and USAGE
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.
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.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
HOW SUPPLIED
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.
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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
PRINCIPAL DISPLAY PANEL - BOTTLE LABEL
30 CAPSULES NDC: 0037-6072-30
natelle®ONE
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Rx Prenatal Vitamin &Plant-Based DHA.
Now with 28 mg Iron
Rx Only
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Distributed by:
MEDA
PHARMACEUTICALS™
Somerset, New Jersey 08873-4120
© 2013 Meda Pharmaceuticals Inc.
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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.
| NATELLE ONE
doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acid capsule, gelatin coated |
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| Labeler - Meda Pharmaceuticals (051229602) |
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