SPL v1
SPL
SPL Set ID 4139742d-d091-121c-e063-6394a90a6221
Route
ORAL
Published
Effective Date 2025-10-15
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Thiamine Ion (5 mg) Niacinamide (35.7 mg) Pyridoxine (25 mg) Ascorbic Acid (65 mg) Pantothenic Acid (20 mg) Riboflavin (1.67 mg) Folic Acid (0.5 mg) Methylcobalamin
Inactive Ingredients
Cellulose, Microcrystalline Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Shape: oval Color: brown Size: 14 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-10-15

Description

Lumavex is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and Administration

Usual adult dosage is one to two capsule daily or as directed by a licensed medical practitioner.

Dosage Forms and Strengths

Lumavex capsules are supplied as clear capsules dispensed in HDPE plastic bottles of 30 count (85477-610-30).

Contraindications

Lumavex is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description

Lumavex is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.

Section 34084-4

Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Section 42232-9

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.

Section 44425-7

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

Section 51945-4

Section 60561-8

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Usual adult dosage is one to two capsule daily or as directed by a licensed medical practitioner.

Dosage Forms and Strengths (34069-5)

Lumavex capsules are supplied as clear capsules dispensed in HDPE plastic bottles of 30 count (85477-610-30).

Contraindications (34070-3)

Lumavex is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings and Precautions (34071-1)

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.

Section 34084-4 (34084-4)

Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Description (34089-3)

Lumavex is a prescription multivitamin/multimineral dietary supplement with 1mg Folic Acid.

Section 42232-9 (42232-9)

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.

Section 44425-7 (44425-7)

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

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)