| Product Name: | Diclofenac Potassium Tablets USP |
| Brand Name: | DICLOTAJ |
| Strength: | 25mg, 50mg, 100mg |
| Dosage Form: | Tablets (film-coated) |
| 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 is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, and joint stiffness caused by arthritis. |
| Storage: | Store at 20°C to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Diclofenac Potassium Tablets USP 25mg(DICLOTAJ)
- Diclofenac Potassium Tablets USP 50mg(DICLOTAJ)
- Diclofenac Potassium Tablets USP 100mg(DICLOTAJ)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Diclofenac Potassium Tablets USP 25mg
Each film-coated tablet contains:
Diclofenac Potassium USP…..25mg
Excipients……………………………q.s
Color: Sunset yellow FCF - Diclofenac Potassium Tablets USP 50mg
Each film-coated tablet contains:
Diclofenac Potassium USP…….. 50mg
Excipients………………………………q.s
Color: Tartrazine yellow - Diclofenac Potassium Tablets USP 100mg
Each film-coated tablet contains:
Diclofenac Potassium USP…….. 100mg
Excipients………………………………q.s
Color: Tartrazine yellow
THERAPEUTIC INDICATIONS:
Diclofenac is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, and joint stiffness caused by arthritis.
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°C to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.