| Product Name: | Hydroxyzine Hydrochloride Tablets IP |
| Brand Name: | Generic |
| Strength: | 10mg, 25mg, 50mg |
| Dosage Form: | Tablets (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: | Antihistamine |
| Indication: | Hydroxyzine is used to help control anxiety and tension caused by nervous and emotional conditions. |
| Storage: | Store at temperature not exceeding 30℃. Store in cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Hydroxyzine Hydrochloride Tablets IP 10mg
- Hydroxyzine Hydrochloride Tablets IP 25mg
- Hydroxyzine Hydrochloride Tablets IP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Hydroxyzine Hydrochloride Tablets IP 10mg
Each film coated tablet contains:
Hydroxyzine Hydrochloride IP……………10mg
Excipients…………………………………………q.s
Colour: Ponceau 4R - Hydroxyzine Hydrochloride Tablets IP 25mg
Each film coated tablet contains:
Hydroxyzine Hydrochloride IP……………25mg
Excipients…………………………………………q.s
Colour: Indigo Carmine Lake - Hydroxyzine Hydrochloride Tablets IP 50mg
Each film coated tablet contains:
Hydroxyzine Hydrochloride IP……………50mg
Excipients…………………………………………q.s
Colour: Indigo Carmine Lake
THERAPEUTIC INDICATIONS:
Hydroxyzine is used to help control anxiety and tension caused by nervous and emotional conditions. It can also be used to help control anxiety and produce sleep before surgery. This medicine is also used to relieve symptoms of allergic conditions (e.g., chronic urticaria and atopic and contact dermatoses).
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablet to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE H PRESCRIPTION DRUG – CAUTION: Not to be sold by retail without the prescription of a 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 the Physician.