| Product Name: | Aceclofenac and Paracetamol Tablets |
| Brand Name: | ACETAJ P |
| Strength: | (100mg+325mg), (100mg+500mg) |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via oral route |
| Packing: | 30s, 90s, 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: | Aceclofenac and Paracetamol tablets is used for fever, Joint pain, Cold, Toothache, Headache, Ear pain and other conditions. |
| Storage: | Do not store above 25°C. Store in the original package in order to protect from moisture. |
Aceclofenac and Paracetamol Tablets (100mg+325mg) Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Aceclofenac and Paracetamol Tablets (100mg+325mg)
2. Aceclofenac and Paracetamol Tablets (100mg+500mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Aceclofenac and Paracetamol Tablets (100mg+325mg)
Each film-coated tablet contains:
Aceclofenac BP………..……….100mg
Paracetamol BP….…………….325mg
Excipients…………………………q.s
Colour: Titanium Dioxide USP
B) Aceclofenac and Paracetamol Tablets (100mg+500mg)
Each film-coated tablet contains:
Aceclofenac IP………..……….100mg
Paracetamol BP….…………….500mg
Excipients…………………………q.s
Colour: Red Oxide of Iron
THERAPEUTIC INDICATIONS:
Aceclofenac and Paracetamol tablets is used for fever, Joint pain, Cold, Toothache, Headache, Ear pain and other conditions.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Do not store above 25°C. Store in the original package in order to protect from moisture.
Dosage: As directed by the Physician.