Natelle One Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources