Paracetamol & caffeine Tablets Technical Specification:
| Product Name: | Paracetamol & caffeine Tablets I.P. |
| Brand Name: | Generic |
| Strength: | 650mg+50mg |
| Dosage Form: | Tablets (Uncoated 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: | Pain reliever/ Analgesic |
| Indication: | Paracetamol & caffeine used to treat mild to moderate pain, including headache, backache, migraine, rheumatic and muscle pain, toothache and period pain |
| Storage: | Temperature not exceed than 30℃, protect from light and Moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Paracetamol 650mg & caffeine 50mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Uncoated tablet contains:
Paracetamol IP…….650mg
Caffeine Anhydrous IP ………………50mg
Excipients……q.s.
Colour: Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Paracetamol & caffeine used to treat mild to moderate pain, including headache, backache, migraine, rheumatic and muscle pain, toothache and period pain
CAUTION & WARNING:
Keep out the reach of children
Contraindicated in patient with known paracetamol Hypersensitivity. Consult your doctor before taking this drug, if you have liver/kidney impairment or blood clotting disorder.
“Not for use by children below the age of 12 years”
Do not use with other paracetamol containing medicines.
SCHEDULE: H PRESCRIPTION DRUG: WARNING: Not to be sold without prescription of Registered Medical Practitioner only.
WARNING: “Taking more than daily dose of paracetamol may cause serious liver damage or allergic reactions (e.g. swelling of the face, mouth and throat, difficulty in breathing, itching or race)”
STORAGE & DOSAGE:
Storage: Temperature not exceed than 30℃, protect from light and Moisture.
Dosage: 1 tablet, 3 to 4 times in divided dose in 24hours or as directed by the Physician. Maximum dose 4 tablets in equally divided doses in 24 hours. Do not exceed stated dose. Do not use for more than two days unless directed by a doctor.