Label: CLANZA CR- aceclofenac tablet, film coated 

  • Label RSS
  • NDC Code(s): 65697-450-20, 65697-450-21, 65697-450-22
  • Packager: United Douglas Pharm., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated 11/11

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

  • DESCRIPTION

    DESCRIPTION

    White, oblong, film-coated tablet, engraved with "UT" on one side and "CL CR" on the other side.

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  • INDICATIONS & USAGE

    INDICATIONS

    CLANZA CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism.

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  • DOSAGE & ADMINISTRATION

    Dosage and Administration

    Adults: The recommended dose is 200 mg daily, taken as one dose (every 24 hours).  However, the dose and dose frequency of CLANZA CR can be modified under the supervison of physician or pharmacist.

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  • CONTRAINDICATIONS

    CONTRAINDICATIONS

    Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.

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  • PRECAUTIONS

    CAUTIONS

    Patients with symptoms indicative of gastro-intestinal disorders, with a history of gastroulceration.  Patients with severe hepatic impairment or cardiac or renal impairment.  Patients under the medication of diuretics.  Patients in recovery after surgical treatment.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS

    The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness.  To report suspected adverse reactions, call 1-800-FDA-1088.

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  • GENERAL PRECAUTIONS

    GENERAL PRECAUTIONS

    Patients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDS should refrain from driving or handling dangerous machinery.

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  • DRUG INTERACTIONS

    DRUG INTERACTIONS

    There has been no drug interactions reported, but close monitoring of patients on combination with lithium and digoxin, oral antidiabetic agents, anticoagulants, diuretics, and other analgesics.

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  • PREGNANCY

    USE IN PREGNANCY AND NURSING MOTHERS

    Since there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of CLANZA CR should therefore be avoided in pregnancy and lactation.

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  • PEDIATRIC USE

    USE IN CHILDREN

    The dosage and indication is not established yet for children with less than 6 years old.

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  • OVERDOSAGE

    OVERDOSAGE

    There are no human data available on the consequences of CLANZA CR overdosage.  If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions.

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  • STORAGE AND HANDLING

    STORAGE

    Preserve in tight containers.  Store at room temperature not exceeding 30oC.

    SHELF LIFE

    Three (3) years from manufacturing date.  Do not exceed the expiry date for use printed on the box.

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  • HOW SUPPLIED

    PACKAGE

    10 Blister Packs with 10 Tablets in each Blister Pack

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  • PATIENT PACKAGE INSERT

    Enter section text here

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  • PRINCIPAL DISPLAY PANEL

    label test Clanza Package Label

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  • INGREDIENTS AND APPEARANCE
    CLANZA  CR
    aceclofenac tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65697-450
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Aceclofenac (Aceclofenac) Aceclofenac 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    Lactose Monohydrate  
    Cellulose, Microcrystalline  
    Sodium Carbonate  
    Colloidal Silicon Dioxide  
    Crospovidone  
    Poloxamer 407  
    Magnesium Stearate  
    Alcohol  
    Hypromellose 2208 (15000 MPA.S)  
    Carbomer 941  
    Hypromellose 2910 (6 MPA.S)  
    Alcohol  
    Methylene Chloride  
    Hypromellose 2910 (5 MPA.S)  
    Titanium Dioxide  
    Ethylcelluloses  
    Diethyl Phthalate  
    Product Characteristics
    Color white Score no score
    Shape OVAL (Film-coated white oblong tablet) Size 15mm
    Flavor Imprint Code UT;CR;CT
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65697-450-20 1 in 1 PACKET
    2 NDC:65697-450-22 10 in 1 CARTON
    2 NDC:65697-450-21 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 05/12/2011
    Labeler - United Douglas Pharm., Inc. (001444350)
    Registrant - United Douglas Pharm., Inc. (001444350)
    Establishment
    Name Address ID/FEI Business Operations
    United Douglas Pharm., Inc. 001444350 pack, label
    Establishment
    Name Address ID/FEI Business Operations
    Korea United Pharm Inc. 688016534 manufacture
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