Storage and handling
STORAGE Preserve in tight containers. Store at room temperature not exceeding 30 o C. SHELF LIFE Three (3) years from manufacturing date. Do not exceed the expiry date for use printed on the box .
Clanza
- Manufacturer
- United Douglas Pharm., Inc. | Korea United Pharm Inc.
- Effective date
- 2011-11-02
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-05-31 20:13:10
Label at a glance#
ProductClanza CR
Active ingredientAceclofenac
Label structure15 sections
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION SECTION
DESCRIPTION
White, oblong, film-coated tablet, engraved with "UT" on one side and "CL CR" on the other side.
INDICATIONS & USAGE SECTION
INDICATIONS
CLANZA CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism.
DOSAGE & ADMINISTRATION SECTION
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.
CONTRAINDICATIONS SECTION
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.
PRECAUTIONS SECTION
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.
ADVERSE REACTIONS SECTION
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.
GENERAL PRECAUTIONS SECTION
GENERAL PRECAUTIONS
Patients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDS should refrain from driving or handling dangerous machinery.
DRUG INTERACTIONS SECTION
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.
PREGNANCY SECTION
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.
PEDIATRIC USE SECTION
USE IN CHILDREN
The dosage and indication is not established yet for children with less than 6 years old.
OVERDOSAGE SECTION
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.
STORAGE AND HANDLING SECTION
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.
HOW SUPPLIED SECTION
PACKAGE
10 Blister Packs with 10 Tablets in each Blister Pack
SPL PATIENT PACKAGE INSERT SECTION
Enter section text here
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
label test 
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65697-450-20 | 2019-11-13 | C162847 | 48780-1 | 97449f38-bb73-f6ea-e053-dbdaa90aa703 | 8a023942-01e8-4849-aa3c-1a640ffc7fd3 |
| 65697-450-22 | 2019-11-13 | C162847 | 48780-1 | 97449f38-bb73-f6ea-e053-dbdaa90aa703 | 8a023942-01e8-4849-aa3c-1a640ffc7fd3 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65697-450-20 | ClanzaCR | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 7 | |
| 65697-450-21 | ClanzaCR | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 7 | |
| 65697-450-22 | ClanzaCR | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Aceclofenac | ACTIVE INGREDIENT | RPK779R03H | 7 | |
| Aceclofenac | ACTIVE MOIETY | RPK779R03H | 7 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 7 | |
| Carbomer 941 | INACTIVE INGREDIENT | F68VH75CJC | 7 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 7 | |
| Colloidal Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 7 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | 7 | |
| Diethyl Phthalate | INACTIVE INGREDIENT | UF064M00AF | 7 | |
| Ethylcelluloses | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 7 | |
| Hypromellose 2208 (15000 MPA.S) | INACTIVE INGREDIENT | Z78RG6M2N2 | 7 | |
| Hypromellose 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | 7 | |
| Hypromellose 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | 7 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | 7 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 7 | |
| Methylene Chloride | INACTIVE INGREDIENT | 588X2YUY0A | 7 | |
| Poloxamer 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | 7 | |
| Sodium Carbonate | INACTIVE INGREDIENT | 45P3261C7T | 7 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 7 |
Products#
Every source-derived product name is available through these pages.
- Clanza CR
- Aceclofenac
- 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)
- Methylene Chloride
- Hypromellose 2910 (5 MPA.S)
- Titanium Dioxide
- Ethylcelluloses
- Diethyl Phthalate
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65697-450 | 65697-450-20, 65697-450-21, 65697-450-22 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| Sodium Carbonate | SODIUM CARBONATE | 45P3261C7T | TABLET, EXTENDED RELEASE / ORAL | 80 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED PELLETS / ORAL | 265 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Hypromellose 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | TABLET / ORAL | 880 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 150 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| Sodium Carbonate | SODIUM CARBONATE | 45P3261C7T | TABLET, EFFERVESCENT / ORAL | 430 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| Sodium Carbonate | SODIUM CARBONATE | 45P3261C7T | INJECTION / SUBCUTANEOUS | ADJ PH | ||
| Hypromellose 2910 (5 MPA.S) | HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | TABLET, FILM COATED / ORAL | 264 mg | ||
| Poloxamer 407 | POLOXAMER 407 | TUF2IVW3M2 | CAPSULE / ORAL | 468 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Carbomer 941 | CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | F68VH75CJC | CAPSULE / ORAL | 32 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FOR SUSPENSION / ORAL | 2794 mg | ||
| Hypromellose 2910 (5 MPA.S) | HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | SPRAY / NASAL | 1 mg/1ml | ||
| Hypromellose 2910 (5 MPA.S) | HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | TABLET, CHEWABLE / ORAL | 120 mg | ||
| Hypromellose 2910 (5 MPA.S) | HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | SUSPENSION / ORAL | 975 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| Sodium Carbonate | SODIUM CARBONATE | 45P3261C7T | LOZENGE / ORAL | 500 mg | ||
| Poloxamer 407 | POLOXAMER 407 | TUF2IVW3M2 | LOTION / TOPICAL | 71 mg | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| Hypromellose 2910 (5 MPA.S) | HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 107 mg | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| Hypromellose 2910 (6 MPA.S) | HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | GRANULE, FOR SUSPENSION / ORAL | 42 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| Diethyl Phthalate | DIETHYL PHTHALATE | UF064M00AF | CAPSULE, EXTENDED RELEASE / ORAL | 172 mg | ||
| Diethyl Phthalate | DIETHYL PHTHALATE | UF064M00AF | TABLET, DELAYED RELEASE / ORAL | 131 mg | ||
| Ethylcelluloses | ETHYLCELLULOSE | 7Z8S9VYZ4B | POWDER / ORAL | 2090 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| Ethylcelluloses | ETHYLCELLULOSE | 7Z8S9VYZ4B | CREAM / TOPICAL | NA | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INHALANT / ORAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| Ethylcelluloses | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 52.5 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CREAM / VAGINAL | 586 mg | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| Lactose Monohydrate | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| Colloidal Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 730de348-1686-4017-804e-010fd87b1f84 | 8a023942-01e8-4849-aa3c-1a640ffc7fd3 | 2011-11-02 | Adverse reactions | 730de348-1686-4017-804e-010fd87b1f84 8a023942-01e8-4849-aa3c-1a640ffc7fd3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.