INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Ocuvel is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. Rx OnlyReserved for Professional RecommendationAll prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under physicians supervision. There are no implied or explicit claims on therapeutic equivalence.Manufactured forAdler- Stern Pharmaeuticals,LLCTampa, FL 33629Rev.12/02-3. Ocuvel Label.

STORAGE AND HANDLING SECTION.

STORAGE. Store at controlled room temperature 15-30C (59F-86F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

WARNINGS AND PRECAUTIONS SECTION.

WARNINGS AND PRECAUTIONS. Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. This medication is generally well tolerated. Notify your doctor if you experience: nausea, loss of appetite, vomiting, stomach cramps, dry mouth, increased thirst, increased urination, muscle or bone pain,headache, weakness, weight loss, dizziness. If you notice other effects not listed above, contact your doctor or pharmacist.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.

DESCRIPTION Ocuvel is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation. Ocuvel should be administered under the supervision of licensed medical practitioner.Each capsule contains:Folic Acid:0.5mg, Vitamin (ascorbic acid):250mg, Vitamin (dl-alpha tocopherol):200IU, Zinc(oxide)40mg, Copper (oxide): 1mg, Lutein :5 mg, Zeaxanthin:1 mg, Each capsule contains the following inactive ingredients: Gelatin, Magnesium Stearate, Silica, FD&C Blue 1, Titanium Dioxide.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Take two capsules daily with or without food or as directed by physician.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Ocuvel capsules are supplied as blue capsules printed with Ocuvel dispensed in HDPE plastic bottles of 60ct.NDC 69054-211-60.