Label: OCUVEL capsule

  • NDC Code(s): 69054-211-60
  • Packager: Adler-Stern Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 2, 2014

If you are a consumer or patient please visit this version.

  • 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

    Ocuvel Label

  • INGREDIENTS AND APPEARANCE
    OCUVEL 
    ocuvel capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69054-211
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Folic Acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) Folic Acid0.5 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID250 mg
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE200 [iU]
    Zinc oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc oxide40 mg
    Copper (UNII: 789U1901C5) (copper - UNII:789U1901C5) Copper1 mg
    Lutein (UNII: X72A60C9MT) (LUTEIN - UNII:X72A60C9MT) Lutein5 mg
    Zeaxanthin (UNII: CV0IB81ORO) (ZEAXANTHIN - UNII:CV0IB81ORO) Zeaxanthin1 mg
    Inactive Ingredients
    Ingredient NameStrength
    Gelatin (UNII: 2G86QN327L)  
    Magnesium Stearate (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapecapsuleSize22mm
    FlavorImprint Code ocuvel
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69054-211-6060 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2014
    Labeler - Adler-Stern Pharmaceuticals, LLC (079403232)