Etoricoxib Tablets USP 90mg Technical Specification:
Product Name: | Etoricoxib Tablets USP |
Brand Name: | Generic |
Strength: | (30mg), (60mg), (90mg), (120mg) |
Dosage Form: | Tablets (film-coated) |
Route of Administration: | Via Oral Route |
Packing: | 10s, 30s, 100s, 500s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antirheumatic, Analgesic and Anti-inflammatory |
Indication: | Etoricoxib is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. |
Storage: | Store at 20° to 25°C (68° to 77°F). Store in a dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Etoricoxib Tablets 30mg
- Etoricoxib Tablets 60mg
- Etoricoxib Tablets 90mg
- Etoricoxib Tablets 120mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Etoricoxib Tablets 30mg
Each film-coated tablet contains:
Etoricoxib USP…………………30mg
Excipients USP…………………q.s
Color: Sunset yellow FCF - Etoricoxib Tablets 60mg
Each film-coated tablet contains:
Etoricoxib USP…………………60mg
Excipients USP…………………q.s
Color: Lake tartrazine - Etoricoxib Tablets 90mg
Each film-coated tablet contains:
Etoricoxib USP…………………90mg
Excipients USP…………………q.s
Color: Ponceau 4 R - Etoricoxib Tablets 120mg
Each film-coated tablet contains:
Etoricoxib USP…………………120mg
Excipients USP…………………q.s
Color: Indigotine
THERAPEUTIC INDICATIONS:
Etoricoxib is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in a dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Etoricoxib Tablets 30mg
B. Etoricoxib Tablets 60mg
C. Etoricoxib Tablets 90mg
D. Etoricoxib Tablets 120mg
B. Etoricoxib Tablets 60mg
C. Etoricoxib Tablets 90mg
D. Etoricoxib Tablets 120mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a. Etoricoxib Tablets 30mg
Each film-coated tablet contains:
Etoricoxib USP……………………30mg
Excipients USP……………………q.s
Color: Sunset yellow FCF
b. Etoricoxib Tablets 60mg
Each film-coated tablet contains:
Etoricoxib USP……………………60mg
Excipients USP……………………q.s
Color: Lake tartrazine
c. Etoricoxib Tablets 90mg
Each film-coated tablet contains:
Etoricoxib USP……………………90mg
Excipients USP……………………q.s
Color: Ponceau 4 R
d. Etoricoxib Tablets 120mg
Each film-coated tablet contains:
Etoricoxib USP……………………120mg
Excipients USP……………………q.s
Color: Indigotine
Each film-coated tablet contains:
Etoricoxib USP……………………30mg
Excipients USP……………………q.s
Color: Sunset yellow FCF
b. Etoricoxib Tablets 60mg
Each film-coated tablet contains:
Etoricoxib USP……………………60mg
Excipients USP……………………q.s
Color: Lake tartrazine
c. Etoricoxib Tablets 90mg
Each film-coated tablet contains:
Etoricoxib USP……………………90mg
Excipients USP……………………q.s
Color: Ponceau 4 R
d. Etoricoxib Tablets 120mg
Each film-coated tablet contains:
Etoricoxib USP……………………120mg
Excipients USP……………………q.s
Color: Indigotine
THERAPEUTIC INDICATIONS:
Etoricoxib is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.