Levocetirizine dihydrochloride Tablets USP 5mg
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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:

 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

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

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.