GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Sertraline Tablets IP 25mg
B) Sertraline Tablets IP 50mg
C) Sertraline Tablets IP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Sertraline Tablets IP 25mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets IP
Equivalent to Sertraline………………25mg
Excipients………………………………………q.s.
Colour: Indigo Carmine

B) Sertraline Tablets IP 50mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets IP
Equivalent to Sertraline………………50mg
Excipients………………………………………q.s.
Colour: Quinoline yellow SS

C) Sertraline Tablets IP 100mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets IP
Equivalent to Sertraline………………100mg
Excipients………………………………………q.s.
Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the Physician

Sertraline Tablets IP 50mg Technical Specification:

Product Name: Sertraline Tablets IP
Brand Name: Generic
Strength: 25mg, 50mg, 100mg
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antidepressants, Central Nervous System
Indication: Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder.
Storage: Store below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • A) Sertraline Tablets IP 25mg
  • B) Sertraline Tablets IP 50mg
  • C) Sertraline Tablets IP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • A) Sertraline Tablets IP 25mg
    Each film coated tablet contains:
    Sertraline Hydrochloride Tablets IP
    Equivalent to Sertraline………………25mg
    Excipients………………………………………q.s.
    Colour: Indigo Carmine
  • B) Sertraline Tablets IP 50mg
    Each film coated tablet contains:
    Sertraline Hydrochloride Tablets IP
    Equivalent to Sertraline………………50mg
    Excipients………………………………………q.s.
    Colour: Quinoline yellow SS
  • C) Sertraline Tablets IP 100mg
    Each film coated tablet contains:
    Sertraline Hydrochloride Tablets IP
    Equivalent to Sertraline………………100mg
    Excipients………………………………………q.s.
    Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

  • Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder.

CAUTION & SCHEDULE:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A Registered Medical Practitioner.

STORAGE & DOSAGE:

  • Storage: Store below 30 °C.Protect from Light and moisture.
  • Dosage: As directed by the Physician