| Product Name: | Promethazine Hydrochloride tablets USP |
| Brand Name: | Generic |
| Strength: | 12.5mg, 25mg, 50mg |
| 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: | Antiallergic, Antihistamine |
| Indication: | Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Promethazine Hydrochloride tablets USP 12.5mg
- Promethazine Hydrochloride tablets USP 25mg
- Promethazine Hydrochloride tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Promethazine Hydrochloride tablets USP 12.5mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………12.5mg
Excipients…………………………………………………..……..q.s
Colour: Sunset yellow FCF - Promethazine Hydrochloride tablets USP 25mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………25mg
Excipients…………………………………………………………..q.s
Colour: Sunset Yellow - Promethazine Hydrochloride tablets USP 50mg
Each Film-coated tablet contains:
Promethazine Hydrochloride USP
Equivalent to Promethazine………………..……………50mg
Excipients…………………………………………………………..q.s
Colour: Sunset yellow lake
THERAPEUTIC INDICATIONS:
Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times.
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, CHILD-RESISTANT CONTAINER AS DEFINED IN THE USP.
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) [See USP Controlled Room Temperature].
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.