| Product Name: | Tramadol Hydrochloride and paracetamol Tablets USP |
| Brand Name: | TRAMATAJ A |
| Strength: | 37.5mg+325mg, 50mg+325mg |
| Dosage Form: | Tablet (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 Tablets each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Analgesic |
| Indication: | Tramadol+ Paracetamol is used in the treatment of moderate to severe pain. Tramadol is an opoid analgesic (pain reliever) which works by blocking the transmission of pain signals to the brain to lower pain perception. Paracetamol works by blocking the release of certain chemical messengers that cause pain. |
| Storage: | Store at temperature not exceeding 30℃. Store in cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Tramadol Hydrochloride and paracetamol Tablets USP(37.5mg +325mg)
- Tramadol Hydrochloride and paracetamol Tablets USP(50mg+325mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tramadol Hydrochloride and paracetamol Tablets USP (37.5mg+325mg)
Each film-coated Tablet contains:
Tramadol Hydrochloride IP……….37.5mg
Paracetamol IP………………………….325mg
COLOUR: Sunset Yellow FCF - Tramadol Hydrochloride and paracetamol Tablets USP(50mg+325mg)
Each film-coated Tablet contains:
Tramadol Hydrochloride IP………50mg
Paracetamol IP………………………….325mg
COLOUR: Sunset Yellow FCF
THERAPEUTIC INDICATIONS:
Tramadol+ Paracetamol is used in the treatment of moderate to severe pain. Tramadol is an opoid analgesic (pain reliever) which works by blocking the transmission of pain signals to the brain to lower pain perception. Paracetamol works by blocking the release of certain chemical messengers that cause pain.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablets to be swallowed as a whole, and not to be chewed or crushed.
WARNING: Taking more than daily dose of Paracetamol may cause serious liver damage or allergic reactions (e.g., Swelling of face, mouth and throat, difficulty in breathing, itching or rash.) SCHEDULE H1 DRUG- WARNING:
It is Dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture.
Dosage: As directed by physician.
For severe acute pain only for a period not exceeding 5 days.