Ketorolac Tromethamine Tablets USP 10mg Technical Specification:
| Product Name: | Ketorolac Tromethamine Tablets USP 10mg |
| Brand Name: | Generic |
| Strength: | 10mg |
| Dosage Form: | Uncoated Dispersible Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSC and CTD Dossier |
| Therapeutic use: | NSAIDs, Analgesic, anti-inflammatory |
| Indication: | To treat moderate to severe pain |
| Storage: | Store between 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ketorolac Tromethamine Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Ketorolac Tromethamine Tablets USP 10mg
Each Uncoated Dispersible Tablet Contains:
Ketorolac Tromethamine IP……………..10 mg
Excipients………………………………………….Q.S.
THERAPEUTIC INDICATIONS:
This medication used in the management and treatment of acute moderate to severe pain, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, menstrual disorders and headaches.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
Not indicated for long term use and for pregnant woman.
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).
DOSAGE: As directed by the Physician.
DIRECTION FOR USE: Make suspension by dispersing the tablet in 5ml (one teaspoonful) of water before administration