NEXA PLUS - ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, biotin, calcium, iron, docusate calcium and schizochytrium dha oil capsule
Upsher-Smith Laboratories, Inc.
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.
Rx Prenatal Vitamin with Plant-Based DHA from Algal Oil
Nexa® Plus Capsules are a prescription prenatal / postnatal multivitamin / mineral softgel capsule with plant-based DHA. Nexa® Plus Capsules are available as opaque brown, oblong capsules imprinted "0374" and are available in 30-count bottles (NDC 0245-0374-30).
|Each softgel capsule contains:|
|Vitamin C (ascorbic acid, USP)||28 mg|
|Vitamin D3 (cholecalciferol, USP)||800 IU|
|Vitamin E (d-alpha tocopherol, USP)||30 IU|
|Vitamin B6 (pyridoxine hydrochloride, USP)||25 mg|
|Folic Acid, USP||1.25 mg|
|Iron (ferrous fumarate, USP)||29 mg|
|Algal oil blend (derived from Crypthecodinium cohnii)||660 mg†|
|Docusate Calcium, USP||55 mg|
Ascorbyl palmitate, corn oil, ethyl vanillin, FD&C Yellow #6, FD&C Red #40, FD&C Blue #1, gelatin, glycerin, lecithin, soybean oil, sunflower oil, titanium dioxide, water, yellow beeswax, white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, simethicone, titanium dioxide).
Nexa® Plus Capsules are indicated to provide vitamin/mineral and plant-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Nexa® Plus may be useful in improving the nutritional status of women prior to conception.
Nexa® Plus Capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of 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 (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.
Nexa® Plus Capsules are available as opaque brown, oblong capsules imprinted "0374" and are available in 30-count bottles (NDC 0245-0374-30).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Upsher-Smith Laboratories, Inc. at 1-888-650-3789.
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447
© 2012 Upsher-Smith Laboratories, Inc.
All rights reserved.
US Patents 5,407,957; 5,492,938
Rx Prenatal Vitamin
with Plant-Based DHA
FROM ALGAL OIL
AND MINERALS INCLUDING
BIOTIN, PLUS DHA AND A
GENTLE STOOL SOFTENER
30 SOFTGEL CAPSULES
ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, biotin, calcium, iron, docusate calcium, and schizochytrium dha oil capsule
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|UNAPPROVED DRUG OTHER||08/01/2012|
|Labeler - Upsher-Smith Laboratories, Inc. (047251004)|
|Upsher-Smith Laboratories, Inc.||047251004||RELABEL, REPACK|
|Catalent Pharma Solutions||051762268||MANUFACTURE, ANALYSIS|
Revised: 07/2012 Upsher-Smith Laboratories, Inc.