FDA Label for Ocuvel
View Indications, Usage & Precautions
Ocuvel Product Label
The following document was submitted to the FDA by the labeler of this product Adler-stern Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 a licensed medical practitioner.
Each capsule contains:Folic Acid:0.5mg, Vitamin C (ascorbic acid):250mg, Vitamin E (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
Indications And Usage
Ocuvel is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
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.
Dosage And Administration
Take two capsules daily with or without food or as directed by a physician.
How Supplied
Ocuvel capsules are supplied as blue capsules printed with Ocuvel dispensed in HDPE plastic bottles of 60ct.
NDC 69054-211-60
Storage
Store at controlled room temperature 15°-30°C (59°F-86°F). 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.
Principal Display Panel
Rx Only
Reserved for Professional Recommendation
All 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 a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.
Manufactured for
Adler- Stern Pharmaeuticals,LLC
Tampa, FL 33629
Rev.12/02-3
* Please review the disclaimer below.