| Product Name: | Promethazine Teoclate Tablet USP |
| Brand Name: | Generic |
| Strength: | 12.5mg, 25mg, 50mg |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-histamine |
| Indication: | This belongs to a group of medicines called phenothiazines. Promazine can be used to calm your emotions particularly if you feel restless and agitated, particularly if you are an older person |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Promethazine Teoclate Tablet USP 12.5mg
- Promethazine Teoclate Tablet USP 25mg
- Promethazine Teoclate Tablet USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Promethazine Teoclate Tablet USP 12.5mg
Each Un-coated tablet contains:
Promethazine Teoclate USP…….…..….12.5mg
Excipients …………………………….…..q.s - Promethazine Teoclate Tablet USP 25mg
Each Un-coated tablet contains:
Promethazine Teoclate USP…….…..….25mg
Excipients …………………………….…..q.s - Promethazine Teoclate Tablet USP 50mg
Each Un-coated tablet contains:
Promethazine Teoclate USP…….…..….50mg
Excipients …………………………….…..q.s
THERAPEUTIC INDICATIONS:
This belongs to a group of medicines called phenothiazines. Promazine can be used to calm your emotions particularly if you feel restless and agitated, particularly if you are an older person.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.Read the enclosed leaflet before use.Keep the medicine out of reach of children.
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).
Dosage: As directed by the Physician.