FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
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
Prenaissance Capsules are a multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
History
There is currently no drug history available for this drug.
Other Information
Prenaissance Capsules are a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is brown in color, opaque and imprinted with “341” on one side.
EACH SOFTGEL CONTAINS:
Vitamin C (ascorbic acid, USP) | 28 mg |
Calcium (tricalcium phosphate, NF) | 160 mg |
Iron (ferrous fumarate, USP) | 29 mg |
Vitamin D3 (cholecalciferol, USP) | 800 IU |
Vitamin E (d-alpha tocopherol, USP) | 30 IU |
Vitamin B6 (pyridoxine HCl, USP) | 25 mg |
Folic Acid, USP | 1.25 mg |
DHA (docosahexaenoic acid) | 325 mg |
Docusate Sodium, USP | 55 mg |
gelatin, glycerin, purified water, soybean oil, lecithin, yellow bees wax, natural creamy orange flavor, titanium dioxide, FD&C red #40, ethyl vanillin, FD&C yellow #5, FD&C blue #1.
Sources
Prenaissance Manufacturers
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Acella Pharmaceuticals, Llc
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