GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Paracetamol BP…………………………….450mg
Orphenadrine Citrate BP...........................35mg
Excipients…………………………………..…q.s.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Warning: Do not give this medicine to a child under the age of 12 years Safety and effectiveness in children younger than 12 years have not been established.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Paracetamol BP 450mg and Orphenadrine Citrate BP 35mg Tablets Technical Specification:
| Product Name: | Paracetamol and Orphenadrine Citrate Tablets |
| Brand Name: | (ORPETAJ) |
| Strength: | 450mg+35mg |
| Dosage Form: | Tablets |
| 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: | Antipyretic tablets. |
| Indication: | to treat acute, painful musculoskeletal conditions. It works as a skeletal muscle relaxant (orphenadrine) and analgesic (paracetamol) to relieve spasms, sprains, strains, tension headaches, and neck/back pain, often acting within one hour. |
| Storage: | Store Protected from moisture at a temperature not exceeding 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Paracetamol and Orphenadrine Citrate Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Each uncoated Tablet contains:
Paracetamol BP…………………………….450mg
Orphenadrine Citrate BP………………………35mg
Excipients…………………………………..…q.s.
THERAPEUTIC INDICATIONS:
The combined analgesic effect of ORPETAJ tablets Paracetamol and muscle relaxant action of Orphenadrine Citrate provides in depth relief from pain associated with skeletal muscle spasm.
CAUTION & WARNING:
CAUTION: Not to be sold by retail without the prescription of a Registered medical practitioner.
Warning: Do not give this medicine to a child under the age of 12 years Safety and effectiveness in children younger than 12 years have not been established.
STORAGE & DOSAGE:
Storage: Store Protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.






