Nexa® Plus Full Prescribing Information
Nexa® Plus Capsules - Rx only
Rx Prenatal Vitamin with Plant-Based DHA from Algal Oil
- 1.25 mg Folic Acid and 350 mg DHA (key omega-3 fatty acid)
- Essential vitamins and minerals
- Gentle stool softener
DESCRIPTION: 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 |
| Biotin |
250 mcg |
| Calcium |
160 mg* |
| Iron (ferrous fumarate, USP) |
29 mg |
| Algal oil blend (derived from Crypthecodinium cohnii) |
660 mg** |
| Docusate Calcium, USP |
55 mg |
* 158 mg calcium from calcium carbonate, USP and 2 mg calcium from docusate calcium, USP
** Providing 350 mg DHA (docosahexaenoic acid)
Other Ingredients: 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).
Contains: Soy
INDICATIONS: 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.
CONTRAINDICATIONS: 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.
WARNING: 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.
WARNING: 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.
PRECAUTION: 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.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.
HOW SUPPLIED: 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.
Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]
Distributed by:
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447
106431-01 Revised 0312
1-800-654-2299 www.upsher-smith.com
© 2012 Upsher-Smith Laboratories, Inc.
All rights reserved.
US Patents 5,407,957; 5,492,938 |