capability Macuvex Generic Name: folic acid, vitamin C, vitamin E, zinc, copper, lutein, zeaxanthin Dosage Form: capsule Print this page 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. Macuvex Rx Only DESCRIPTION Macuvex is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation. Macuvex 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 Macuvex 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 Macuvex capsules are supplied as blue capsules printed with Macuvex dispensed in HDPE plastic bottles of 60ct. NDC 69336-400-60 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 Sterling-Knight Pharmaeuticals,LLC Ripley, MS 33663 Rev.10/13-2 Macuvex Macuvex capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69336-400 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (FOLIC ACID) Folic Acid 1 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 250 mg ALPHA-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 200 [iU] Zinc oxide (ZINC OXIDE) Zinc oxide 40 mg Copper (copper) Copper 1 mg Lutein (LUTEIN) Lutein 5 mg Zeaxanthin (ZEAXANTHIN) Zeaxanthin 1 mg Inactive Ingredients Ingredient Name Strength Gelatin Magnesium Stearate SILICON DIOXIDE FD&C BLUE NO. 1 Titanium Dioxide Product Characteristics Color blue Score no score Shape capsule Size 22mm Flavor Imprint Code Macuvex Contains Packaging # Item Code Package Description 1 NDC:69336-400-60 60 CAPSULE in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/16/2014 Labeler - Sterling-knight Pharmaceuticals,LLC (079556942) Revised: 04/2015 Sterling-knight Pharmaceuticals,LLC FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More take the plunge
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