Paracetamol 450mg and Orphenadrine Citrate 35mg Tablets Technical Specification:
| Product Name: | Paracetamol 450mg and Orphenadrine Citrate 35mg Tablets |
| Brand Name: | OREPETAJ |
| Strength: | 450+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: | Fast-acting relief from acute, painful musculoskeletal conditions |
| Indication: | short-term relief of acute pain stemming from muscle spasms, sprains, strains, and tension headaches. |
| Storage: | Store protected from moisture at a temperature not exceeding 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Paracetamol 450mg and Orphenadrine Citrate 35mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Each Uncoated tablet contains:
Paracetamol BP………………………………………450mg
Orphenadrine Citrate BP………………………………35mg
Excipients………………………………………………………………q. s
THERAPEUTIC INDICATIONS:
short-term relief of acute, painful musculoskeletal conditions. The combination provides in-depth relief by combining an analgesic with a muscle relaxant
CAUTION & WARNING:
CAUTION: Not to be sold by retail without the Prescription of a Registered Medical Practitioner.
Warning: Do not exceed 6 tablets/24 hours, avoid alcohol, and do not drive if sleepy.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Paracetamol 450mg and Orphenadrine Citrate 35mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Each Uncoated tablet contains:
Paracetamol BP………………………………………450mg
Orphenadrine Citrate BP………………………………35mg
Excipients………………………………………………………………q. s
Paracetamol BP………………………………………450mg
Orphenadrine Citrate BP………………………………35mg
Excipients………………………………………………………………q. s
THERAPEUTIC INDICATIONS:
short-term relief of acute, painful musculoskeletal conditions. The combination provides in-depth relief by combining an analgesic with a muscle relaxant
CAUTION & WARNING:
CAUTION: Not to be sold by retail without the Prescription of a Registered Medical Practitioner.
Warning: Do not exceed 6 tablets/24 hours, avoid alcohol, and do not drive if sleepy.
Warning: Do not exceed 6 tablets/24 hours, avoid alcohol, and do not drive if sleepy.
STORAGE & DOSAGE:
Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.










