FDA records indicate that there are no current recalls for this drug.
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Prefol-dha Recall
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Questions & Answers
Side Effects & Adverse Reactions
Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids - including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
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
PreFol-DHA™ is indicated for the supplemental requirements 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
PreFol-DHA™ is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. PreFol-DHA™ are oblong, maroon softgel capsules with “M100” imprinted on one side.
Each capsule has the following active ingredient:
Folic Acid................................................................................1.2 mg
Each capsule also contains the following ingredients for nutritional supplementation:
Vitamin C (ascorbic acid) ...................................................... 28 mg
Calcium (tribasic calcium phosphate) ................................. 160 mg
Iron (ferrous fumarate) ......................................................... 26 mg
Vitamin D3 (cholecalciferol) ................................................. 400 IU
Vitamin E (d-alpha tocopherol).............................................. 30 IU
Vitamin B6 (pyridoxine hydrochloride) ................................ 25 mg
DHA (Docosahexaenoic Acid)............................................... 300 mg*
Docusate Sodium................................................................ 55 mg
*from approximately 350 mg of Omega-3s derived from approximately 380 mg
Sources
Prefol-dha Manufacturers
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Method Pharmaceuticals, Inc.
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