Folcal Dha Recall
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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.
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
Folcal DHA Capsules are indicated to provide vitamin/mineral and DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Folcal DHA may be useful in improving the nutritional status of women prior to conception.
There is currently no drug history available for this drug.
Folcal DHA Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with DHA. Each softgel capsule is maroon in color, opaque, and imprinted with "ML 352" in white.
|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)||400 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)||300 mg|
|Docusate Sodium, USP||55 mg|
Inactive Ingredients: Fish Oil, Gelatin NF, Sorbitol Sorbitan Solution NF, Glycerin USP, USP Purified Water, Soybean Oil USP, Yellow Beeswax NF, Lecithin NF (Bleached), Ethyl Vanillin, Titanium Dioxide, FD&C Red#40, FD&C Blue#1, White Edible Ink