Dosage Form: capsule, gelatin coated
PreNexa® premier capsules
Rx only
Rx Prenatal Vitamin with Plant-Based DHA
- 1.25 mg Folic Acid and 310 mg DHA (key omega-3 fatty acid)
- Essential vitamins and minerals
- Gentle stool softener
PreNexa Premier Description
PreNexa® premier capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with plant-based DHA. PreNexa® premier capsules are available as opaque brown, oblong capsules imprinted "0179" and are available in 30-count bottles (NDC 0245-0179-30).
Each softgel capsule contains:
| Vitamin C (ascorbic acid, USP) | 28 mg |
| Calcium (tribasic calcium phosphate, NF) | 160 mg |
| Iron (ferrous fumarate, USP) | 27 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 |
| DHA (docosahexaenoic acid, contained in the oil derived from microalgae) | 310 mg |
| Docusate Sodium, USP | 55 mg |
Inactive Ingredients: Ethyl vanillin, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, palm kernel oil, sodium benzoate, soybean oil, sunflower oil, titanium dioxide, yellow beeswax, water and white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, simethicone, titanium dioxide).
Contains: Soy
INDICATIONS
PreNexa® premier 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. PreNexa® premier may be useful in improving the nutritional status of women prior to conception.
Contraindications
PreNexa® premier 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 THE 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.
PreNexa Premier Dosage and Administration
Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.
How is PreNexa Premier Supplied
PreNexa® premier capsules are available as opaque brown, oblong capsules imprinted "0179" and are available in 30-count bottles (NDC 0245-0179-30).
KEEP THIS AND ALL DRUGS OUT OF 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 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
MADE IN CANADA
1-800-654-2299 www.upsher-smith.com
US Patents 5,407,957; 5,492,938; 6,410,281; 7,163,811. Other US Patents Pending.
PreNexa® premier capsules
Revised 0710
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
NDC 0245-0179-30
Rx ONLY
DAILY-CAPSULE
PreNexa®
premier
Rx PRENATAL VITAMIN WITH
PLANT-BASED DHA
ONCE-DAILY
DHA
PLANT-BASED
ESSENTIAL VITAMINS,
MINERALS AND DHA
WITH A GENTLE
STOOL SOFTENER
30 SOFTGEL CAPSULES
UPSHER-SMITH
| PRENEXA PREMIER ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium capsule, gelatin coated | ||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 10/18/2010 | ||
| Labeler - Upsher-Smith Laboratories, Inc. (047251004) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Upsher-Smith Laboratories, Inc. | 047251004 | ANALYSIS | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Accucaps Industries Limited | 248441727 | ANALYSIS, MANUFACTURE | |
More PreNexa Premier resources
- PreNexa Premier Use in Pregnancy & Breastfeeding
- Drug Images
- PreNexa Premier Drug Interactions
- PreNexa Premier Support Group
- 21 Reviews for PreNexa Premier - Add your own review/rating
Compare PreNexa Premier with other medications
- Vitamin/Mineral Supplementation during Pregnancy/Lactation
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