| Product Name: | Levocetirizine dihydrochloride tablet USP |
| Brand Name: | Generics |
| Strength: | 5mg,10mg |
| Dosage Form: | Tablets (Film Coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 100s,300s,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: | Antihistamines, Anti-allergic. |
| Indication: | Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. It is also used to relieve itching and hives. Levocetirizine is used to relieve the symptoms of high fever and hives of the skin. |
| Storage: | Store protected from light and moisture at a temperature not exceeding 300 C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Levocetirizine dihydrochloride tablet USP 5mg
- Levocetirizine dihydrochloride tablet USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Levocetirizine dihydrochloride tablet USP 5mg
Each film-coated tablet contains:
Levocetirizine dihydrochloride USP………….5mg
Excipients……………………………………………q. s
Colures: Iron Oxide Yellow - Levocetirizine dihydrochloride tablet USP 10mg
Each film-coated tablet contains:
Levocetirizine dihydrochloride USP……………10mg
Excipients……………………………………………. q.s.
Colures: Quinoline Yellow Lake
THERAPEUTIC INDICATIONS:
Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. It is also used to relieve itching and hives. Levocetirizine is used to relieve the symptoms of high fever and hives of the skin.
CAUTION & WARNING:
CAUTION:Read enclosed leaflet before use.
Keep 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 below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.