CLANZA CR- aceclofenac tablet, film coated 
United Douglas Pharm., Inc.



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


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

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.


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.


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.


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.


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


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.


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.


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


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.


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


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


10 Blister Packs with 10 Tablets in each Blister Pack

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label test Clanza Package Label

aceclofenac tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65697-450
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aceclofenac (UNII: RPK779R03H) (Aceclofenac - UNII:RPK779R03H) Aceclofenac 200 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate (UNII: EWQ57Q8I5X)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Sodium Carbonate (UNII: 45P3261C7T)  
Colloidal Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Crospovidone (UNII: 68401960MK)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Magnesium Stearate (UNII: 70097M6I30)  
Alcohol (UNII: 3K9958V90M)  
Hypromellose 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
Carbomer 941 (UNII: F68VH75CJC)  
Hypromellose 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
Alcohol (UNII: 3K9958V90M)  
Methylene Chloride (UNII: 588X2YUY0A)  
Hypromellose 2910 (5 MPA.S) (UNII: R75537T0T4)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Ethylcelluloses (UNII: 7Z8S9VYZ4B)  
Diethyl Phthalate (UNII: UF064M00AF)  
Product Characteristics
Color white Score no score
Shape OVAL (Film-coated white oblong tablet) Size 15mm
Flavor Imprint Code UT;CR;CT
# 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)
Name Address ID/FEI Business Operations
United Douglas Pharm., Inc. 001444350 pack, label
Name Address ID/FEI Business Operations
Korea United Pharm Inc. 688016534 manufacture

Revised: 11/2011
Document Id: 730de348-1686-4017-804e-010fd87b1f84
Set id: 8a023942-01e8-4849-aa3c-1a640ffc7fd3
Version: 7
Effective Time: 20111102
United Douglas Pharm., Inc.