GENERIC NAME OF THE MEDICINAL PRODUCT:

Loratadine Tablets USP 5mg
Loratadine Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Loratadine Tablets USP 5mg
Each uncoated tablet contains:
Loratadine USP……………5mg
Excipients…………………………q.s.
Colour: Erythrosine Lake

b) Loratadine Tablets USP 10mg
Each uncoated tablet contains:
Loratadine USP………………10mg
Excipients…………………………. q.s.
Colour: Carmoisine

THERAPEUTIC INDICATIONS:

Loratadine Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
Loratadine is used to temporarily relieve the symptoms of high fever (allergy to pollen, dust, or other substances in the air) and other allergies.

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 protected from light and moisture at a temperature not exceeding 300 C. Keep out of reach of children.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Loratadine Tablets USP Technical Specification:

Product Name:
 Loratadine Tablets USP
Brand Name: Generics
Strength: 5mg,10mg
Dosage Form: Tablets
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: Antihistamine, Anti-allergic.
Indication: Loratadine Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
Storage: Store protected from light and moisture at a temperature not exceeding 300 C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Loratadine Tablets USP 5mg
  • Loratadine Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Loratadine Tablets USP 10mg
Each uncoated tablet contains:
Loratadine USP……………10mg
Excipients…………………………q.s.
Colour: Erythrosine Lake

b) Loratadine Tablets USP 5mg
Each uncoated tablet contains:
Loratadine USP………………5mg
Excipients………………………….q.s.
Colour: Carmoisine

THERAPEUTIC INDICATIONS:

  • Loratadine Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies.

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 protected from light and moisture at a temperature not exceeding 300 C. Keep out of reach of children.
  • Dosage: As directed by the Physician.
Attach dispensing label as per end county.