Description
Foltira is an orally administered prescription folate product.
Foltira Tablet
FDA Label NDC 85477-921
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Foltira (NDC 85477-921). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indications & usage, precautions, warnings, dosage & administration, other safety information, how supplied, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Foltira is for patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.
Precautions
Foltira should be administered under the supervision of a licensed medical practitioner.
Warnings
Keep out of reach of children.
Dosage & Administration
Take one tablet daily or as directed by a licensed medical practitioner. If you are pregnant or nursing ask a healthcare professional.
Other Safety Information
Store at 20°C - 25°C (68°-77°F) [See USP Controlled Room Temperature.]
How Supplied
NDC 85477-921-30
Distributed by:
Oncora Pharma
Dallas, Texas 75228
Package Label.Principal Display Panel
Label (Foltira)
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