GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Diclofenac Sodium BP…………….50mg
Paracetamol BP………………………500mg
Excipients…………………………………q.s
Color: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the usp using a child-resistant closure.
Keep container tightly closed.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Diclofenac Sodium and Paracetamol Tablets IP 50mg+500mg Technical Specification:
| Product Name: | Diclofenac Sodium and Paracetamol Tablets |
| Brand Name: | Generic |
| Strength: | (50mg+500mg) |
| Dosage Form: | Tablets (uncoated) |
| 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: | Analgesic and Anti-inflammatory, Antirheumatic |
| Indication: | Diclofenac+Paracetamol is used for pain relief. It relieves pain in conditions like headache, mild migraine, muscle pain, dental pain, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, or painful menses. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Diclofenac Sodium and Paracetamol Tablets 50mg+500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Diclofenac Sodium and Paracetamol Tablets 50mg+500mg
Each uncoated tablet contains:
Diclofenac Sodium BP…………….50mg
Paracetamol BP………………………500mg
Excipients…………………………………q.s
Color: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
Diclofenac+Paracetamol is used for pain relief. It relieves pain in conditions like headache, mild migraine, muscle pain, dental pain, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, or painful menses.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.
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 country.
