Levocetirizine dihydrochloride Tablets USP 5mg Technical Specification:
| Product Name: | Levocetirizine dihydrochloride Tablets USP 5mg |
| Brand Name: | Generic |
| 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 |
| 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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light resistance containers as defined in the USP. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Levocetirizine dihydrochloride Tablets USP 5mg
- Levocetirizine dihydrochloride Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Levocetirizine dihydrochloride Tablets USP 5mg
Each film-coated tablet contains:
Levocetirizine dihydrochloride USP………….5m
Excipients……………………………………………q. s
Colures: Iron Oxide Yellow
- Levocetirizine dihydrochloride Tablets USP 10mg
Each film-coated tablet contains:
Levocetirizine dihydrochloride USP……………10mg
Excipients……………………………………………. q.s.
Colures: Red oxide of iron
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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight, light-resistance containers as defined in the USP.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Levocetirizine dihydrochloride Tablets USP 5mg
B. Levocetirizine dihydrochloride Tablets USP 10mg
B. Levocetirizine dihydrochloride Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Levocetirizine dihydrochloride Tablets USP 5mg
Each film-coated tablet contains:
Levocetirizine dihydrochloride USP………….5m
Excipients……………………………………………q. s
Colures: Iron Oxide Yellow
B. Levocetirizine dihydrochloride Tablets USP 10mg
Each film-coated tablet contains:
Levocetirizine dihydrochloride USP…………...10mg
Excipients……………………………………………. q.s.
Colures: Red oxide of iron
Each film-coated tablet contains:
Levocetirizine dihydrochloride USP………….5m
Excipients……………………………………………q. s
Colures: Iron Oxide Yellow
B. Levocetirizine dihydrochloride Tablets USP 10mg
Each film-coated tablet contains:
Levocetirizine dihydrochloride USP…………...10mg
Excipients……………………………………………. q.s.
Colures: Red oxide of iron
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.
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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight, light resistance containers as defined in the USP.
Dosage: As directed by the Physician.
Dispense in tight, light resistance containers as defined in the USP.
Dosage: As directed by the Physician.
