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Febuxostat Tablet 40mg Febuxostat Tablet 40mg Febuxostat Tablet 40mg Febuxostat Tablet 40mg Febuxostat Tablet 40mg Febuxostat Tablet 40mg
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Febuxostat Tablet 40mg Technical Specification:

Product Name:Febuxostat Tablet
Brand Name:Generics
Strength:40mg, 80mg, 120mg
Dosage Form:Tablet (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 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:Antigout Drugs, Antihyperuricemic agents.
Indication: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.
Storage:Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Febuxostat Tablet 40mg
  • Febuxostat Tablet 80mg
  • Febuxostat Tablet 120mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Febuxostat Tablet 40mg
    Each film-coated tablet contains:
    Febuxostat…………………….40mg
    Excipients………………………q.s.
    Colour: Ponceau 4R
  • Febuxostat Tablet 80mg
    Each film-coated tablet contains:
    Febuxostat…………………….80mg
    Excipients………………………q.s.
    Colour: Quinoline Yellow
  • Febuxostat Tablet 120mg
    Each film-coated tablet contains:
    Febuxostat…………………….120mg
    Excipients………………………q.s.
    Colour: FD&C Yellow 6

THERAPEUTIC INDICATIONS:

Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the 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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.

Dosage: As directed by the Physician.
Attach dispensing label as per end county.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Febuxostat Tablet 40mg
 B. Febuxostat Tablet 80mg
C. Febuxostat Tablet 120mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a. Febuxostat Tablet 40mg
Each film-coated tablet contains:
Febuxostat…………………….40mg
Excipients………………………q.s.
Color: Ponceau 4R

 b. Febuxostat Tablet 80mg
Each film-coated tablet contains:
Febuxostat…………………….80mg
Excipients………………………q.s.
Color: Quinoline Yellow

c. Febuxostat Tablet 120mg
Each film-coated tablet contains:
Febuxostat…………………….120mg
Excipients………………………q.s.
Color: FD&C Yellow 6

THERAPEUTIC INDICATIONS:

Treatment of chronic hyperuricemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.

CAUTION & WARNING:

CAUTION:
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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.