GENERIC NAME OF THE MEDICINAL PRODUCT

A. Flurbiprofen Tablets USP 50mg
B. Flurbiprofen Tablets USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Flurbiprofen Tablets USP 50mg
Each Film-coated tablet contains:
Flurbiprofen USP……………..50mg
Excipients………………………...q.s
Colour: Quinoline Yellow WS

B) Flurbiprofen Tablets USP 100mg
Each Film-coated tablet contains:
Flurbiprofen USP……………..100mg
Excipients………………………...q.s
Colour: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Tablets to be swallowed as a whole, and not to be chewed or crushed.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

STORAGE & DOSAGE:

Storage: Store at 20℃ to 25℃. [See USP Controlled Room Temperature].
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the physician.

Flurbiprofen Tablets USP 100mg Technical specification:

Product Name: Flurbiprofen Tablets USP
Brand Name: Generic
Strength: 50MG, 100MG
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 10 strips of 10 tablets each
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, FSC, COPP, Stability Studies, GMP
Therapeutic use: NSAIDs
Indication: Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.
Storage: Store at 20℃ to 25℃. [See USP Controlled Room Temperature]. Store in cool, dry & dark place. Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  1. Flurbiprofen Tablets USP 50mg
  2. Flurbiprofen Tablets USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Flurbiprofen Tablets USP 50mg
    Each Film-coated tablet contains:
    Flurbiprofen USP……………..50mg
    Excipients…………………………q.s
    Colour: Quinoline Yellow WS
  2. Flurbiprofen Tablets USP 100mg
    Each Film-coated tablet contains:
    Flurbiprofen USP……………..100mg
    Excipients…………………………q.s
    Colour: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

  • Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.

CAUTION & WARNING:

  • CAUTION:  Read enclosed leaflet before use. Keep medicine out of reach of children.Tablets to be swallowed as a whole, and not to be chewed or crushed.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

STORAGE & DOSAGE:

  • Storage:  Store at 20℃ to 25℃. [See USP Controlled Room Temperature].  Store in cool, dry & dark place.  Protect from Light & moisture.
  • Dosage:  As directed by the physician.