Folixapure

Folixapure is an FDA drug label for the active ingredient FOLIC ACID, VITAMIN D3 manufactured by PureTek Corporation administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230111.

Generic: FOLIC ACID, VITAMIN D3

Manufacturer: PureTek Corporation

Product Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form:

NDC: 59088-163

Application:

Effective: 20230111

Indications & Usage

INDICATIONS AND DOSAGE Folixapure™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation. Folixapure™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.

Dosage & Administration

DOSAGE AND ADMINISTRATION Take one tablet daily or as directed by a healthcare practitioner.

Contraindications

CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Folixapure™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Warnings

Not available.

Adverse Reactions

ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.

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