| Product Name: | Promethazine HCl Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 25mg/ml, 50mg/2ml, 150mg/6ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml Ampoule & 1ml vial |
| Route of Administration: | For I.M and slow I.V. injection |
| 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-Allergic, Anti-histamine |
| Indication: | Promethazine injection is used to relieve or prevent some types of allergies or allergic reactions. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Promethazine HCl Injection USP 25mg/ml
- Promethazine HCl Injection USP 50mg/2ml
- Promethazine HCl Injection USP 150mg/6ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Promethazine HCl Injection USP 25mg/ml
Each ml contains:
Promethazine Hydrochloride USP……….25mg
Excipients………………………q.s.
Water for Injection USP………….q.s. - Promethazine HCl Injection USP 50mg/2ml
Each ml contains:
Promethazine Hydrochloride USP……….50mg
Excipients………………………q.s.
Water for Injection USP………….q.s. - Promethazine HCl Injection USP 150mg/6ml
Each ml contains:
Promethazine Hydrochloride USP……….150mg
Excipients………………………q.s.
Water for Injection USP………….q.s.
THERAPEUTIC INDICATION:
Promethazine injection is used to relieve or prevent some types of allergies or allergic reactions. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.
CAUTION & WARNING:
CAUTION: Discolored solution or solution with any visible suspended material should not be used.
Do not use if any particle, leakage, or breakage is found.
DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°).
See USP-controlled room temperature.
Dosage: As directed by the Physician.