Desloratadine Tablet USP 5mg Technical Specification:
| Product Name: | Desloratadine Tablet USP 5mg |
| Brand Name: | Desitin |
| Strength: | 5mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 50s, 100s, 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-histamine |
| Indication: | Desloratadine is an antihistamine. It is used to relieve the symptoms of hay fever and hives of the skin. Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Desloratadine Tablet USP 5mg (Desitin)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Desloratadine Tablet USP
Each film coated tablet contains:
Desloratadine USP …………………………….5mg
Excipients………………………………………..q.s.
Colour: Ferric Oxide Red USP-NF
THERAPEUTIC INDICATIONS:
Desloratadine is an antihistamine. It is used to relieve the symptoms of hay fever and hives of the skin. Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.
CAUTION & WARNING:
CAUTION: Preserve in tight container.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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).
Dosage: As directed by the Physician
Attach dispensing label as per end country.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Desloratadine Tablet USP 5mg (Desitin)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Desloratadine Tablet USP
Each film coated tablet contains:
Desloratadine USP …………………………….5mg
Excipients………………………………………..q.s.
Colour: Ferric Oxide Red USP-NF
Each film coated tablet contains:
Desloratadine USP …………………………….5mg
Excipients………………………………………..q.s.
Colour: Ferric Oxide Red USP-NF
THERAPEUTIC INDICATIONS:
Desloratadine is an antihistamine. It is used to relieve the symptoms of hay fever and hives of the skin. Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.
CAUTION & WARNING:
CAUTION: Preserve in tight container.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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).
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
