Fexofenadine Hydrochloride Tablets USP 180mg Technical Specification:

Product Name:Fexofenadine Hydrochloride Tablets USP 180mg
Brand Name:FEXOLLER
Strength:(120mg), (180mg)
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 20s, 30s, 50s, 100s
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: Fexofenadine 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.
Storage:Store at 20° to 25°C (68° to 77°F). Protect from Light and Moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Fexofenadine Hydrochloride Tablets USP 120mg (FEXOLLER)
    Each Film-coated tablet contains:
    Fexofenadine Hydrochloride BP…….…….120mg
    Excipients …………………………………..…….…..q.s
    Colour: Titanium Dioxide USP
  • Fexofenadine Hydrochloride Tablets USP 180mg (FEXOLLER)
    Each Film-coated tablet contains:

    Fexofenadine Hydrochloride BP…….…..….180mg
    Excipients …………………………………..…….…..q.s
    Colour: Ferric Oxide of Iron Yellow.

THERAPEUTIC INDICATIONS:

Fexofenadine 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 enclosed leaflet before use.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
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). Protect from Light and Moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Fexofenadine Hydrochloride Tablets USP 120mg (FEXOLLER)
B) Fexofenadine Hydrochloride Tablets USP 180mg (FEXOLLER)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Fexofenadine Hydrochloride Tablets USP 120mg (FEXOLLER)
Each Film-coated tablet contains:
Fexofenadine Hydrochloride BP…….…….120mg
Excipients …………………………………..…….…..q.s
Colour: Titanium Dioxide USP

B) Fexofenadine Hydrochloride Tablets USP 180mg (FEXOLLER)
Each Film-coated tablet contains:
Fexofenadine Hydrochloride BP…….…..….180mg
Excipients …………………………………..…….…..q.s
Colour: Ferric Oxide of Iron Yellow.

THERAPEUTIC INDICATIONS:

Fexofenadine 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 enclosed leaflet before use.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
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). Protect from Light and Moisture.
Dosage: As directed by the Physician.