Label: OCUVEL capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 69054-210-60 - Packager: Adler-Stern Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 3, 2014
If you are a consumer or patient please visit this version.
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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:1mg, Vitamin C (ascorbic acid):500mg, Vitamin E (dl-alpha tocopherol):400IU, Zinc(oxide)80mg, Copper (oxide): 2mg, Lutein :10 mg, Zeaxanthin:2 mg, Each capsule contains the following inactive ingredients: Gelatin, Magnesium Stearate, Silica, FD&C Blue #1, Titanium Dioxide
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
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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.
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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
- HOW SUPPLIED
- STORAGE
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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 33626
Rev.10/14-2
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INGREDIENTS AND APPEARANCE
OCUVEL
ocuvel capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69054-210 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) Folic Acid 1 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 500 mg ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE 400 [iU] Zinc oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc oxide 80 mg Copper (UNII: 789U1901C5) (copper - UNII:789U1901C5) Copper 2 mg Lutein (UNII: X72A60C9MT) (LUTEIN - UNII:X72A60C9MT) Lutein 10 mg Zeaxanthin (UNII: CV0IB81ORO) (ZEAXANTHIN - UNII:CV0IB81ORO) Zeaxanthin 2 mg Inactive Ingredients Ingredient Name Strength Gelatin (UNII: 2G86QN327L) Magnesium Stearate (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape capsule Size 22mm Flavor Imprint Code ocuvel Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69054-210-60 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/05/2014 Labeler - Adler-Stern Pharmaceuticals, LLC (079403232)