Description
Lumavex is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.
Lumavex Capsule
FDA Label NDC 85477-610
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 Lumavex (NDC 85477-610). 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, contraindications, precautions, warnings, adverse reactions, dosage & administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Lumavex is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate and maintenance of good health is needed.
Contraindications
Lumavex is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Warnings
WARNING If you are pregnant or nursing, ask a health care professional before using this product. Keep this product out of the reach of children.
Adverse Reactions
Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Dosage & Administration
Usual adult dosage is one to two capsule daily or as directed by a licensed medical practitioner.
How Supplied
Lumavex capsules are supplied as clear capsules dispensed in HDPE plastic bottles of 30 count (85477-610-30).
Storage And Handling
STORAGE: Store at controlled room temperature 15°-30° C (59°-86° F). Keep in a cool dry place.
MADE IN USA
Distributed by:
888-321-2821
Oncora Pharma
Dallas, TX 75161
Other Safety Information
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
Package Label.Principal Display Panel
Label (Lumavex)
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