Promethazine Hydrochloride Tablets IP 10mg Technical Specification:
| Product Name: | Promethazine Hydrochloride Tablets IP 10mg |
| Brand Name: | Generic |
| Strength: | (10mg), (25mg) |
| Dosage Form: | Tablets(Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antiallergic, Antihistamine |
| Indication: | Promethazine is a medication used to manage and treat allergic conditions, nausea and vomiting, motion sickness, and sedation. It also has off-label uses for nausea and vomiting in pregnancy. Promethazine is a phenothiazine derivative with antidopaminergic, antihistamine, and anticholinergic properties. |
| Storage: | Store below 30°C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Promethazine Hydrochloride Tablets IP 10mg
- Promethazine Hydrochloride Tablets IP 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Promethazine Hydrochloride Tablets IP 10mg
Each Film-coated tablet contains:
Promethazine Hydrochloride IP………………10mg
Excipients………………………………………………..q.s
Colour: Titanium Dioxide IP
- Promethazine Hydrochloride Tablets IP 25mg
Each Film-coated tablet contains:
Promethazine Hydrochloride IP………………25mg
Excipients……………………………………………….q.s
Colour: Brilliant Blue & Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
Promethazine is a medication used to manage and treat allergic conditions, nausea and vomiting, motion sickness, and sedation. It also has off-label uses for nausea and vomiting in pregnancy. Promethazine is a phenothiazine derivative with antidopaminergic, antihistamine, and anticholinergic properties.
CAUTION & SCHEDULE:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
MAY CAUSE DROWSINESS. IF AFFECTED DO NOT DRIVE OR OPERATE MACHINERY. AVOID ALCOHOLIC DRINKS.
SCHEDULE: SCHEDULE H CAUTION: TO BE SOLD BY RETAIL on THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
SCHEDULE: SCHEDULE G CAUTION: IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from Light and moisture.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Promethazine Hydrochloride Tablets IP 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Promethazine Hydrochloride IP………………10mg
Excipients………………………………………………..q.s
Colour: Titanium Dioxide IP
b) Promethazine Hydrochloride Tablets IP 25mg
Each Film-coated tablet contains:
Promethazine Hydrochloride IP………………25mg
Excipients……………………………………………….q.s
Colour: Brilliant Blue & Titanium Dioxide IP
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
MAY CAUSE DROWSINESS. IF AFFECTED DO NOT DRIVE OR OPERATE MACHINERY. AVOID ALCOHOLIC DRINK.
SCHEDULE: SCHEDULE H CAUTION: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
SCHEDULE: SCHEDULE G CAUTION: IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
