| Product Name: | Cetirizine Hydrochloride Tablets USP |
| Brand Name: | Generic |
| Strength: | 5mg, 10mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 90s, 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: | Anti-allergic, Antihistamine. |
| Indication: | Cetirizine Hydrochloride is used for the relief of symptoms of high fever and other allergic conditions (e.g., sneezing, runny or itchy nose) or for skin rashes (chronic nettle rash, idiopathic urticaria) in adults and children over 6 years of age. |
| Storage: | Do not store above 25°C. Store in the original package in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cetirizine Hydrochloride Tablets USP 5mg
- Cetirizine Hydrochloride Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cetirizine Hydrochloride USP 5mg
Each film coated Tablet contains:
Cetirizine Hydrochloride USP………………5mg
Excipients………………………………. q. s
Color: Titanium Dioxide - Cetirizine Hydrochloride USP 10mg
Each film coated Tablet contains:
Cetirizine Hydrochloride USP………….…….10mg
Excipients…………………………………. q. s
Color: Iron Oxide Red
THERAPEUTIC INDICATIONS:
Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.Do not take Cetirizine hydrochloride after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Do not store above 25°C. Store in the original package in order to protect it from moisture.
Dosage: As directed by the Physician.