Sertraline HCl Tablets USP 50mg Technical Specification:

Product Name:    Sertraline HCl Tablets USP
Brand Name:Generics
Strength:25mg, 50mg, 100mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 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: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 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Sertraline HCl Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sertraline HCl Tablets USP 50mg
    Each film coated tablet contains:
    Sertraline Hydrochloride Tablets USP
    Equivalent to Sertraline……………….50mg
    Excipients………………………………………q.s.
    Colour: Brilliant Blue

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

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage: As directed by the Physician.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Sertraline HCl Tablets USP 25mg
B) Sertraline HCl Tablets USP 50mg
C) Sertraline HCl Tablets USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

B) Sertraline HCl Tablets USP 50mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
Equivalent to Sertraline……………....50mg
Excipients………………………………………q.s.
Colour: Brilliant Blue


C) Sertraline HCl Tablets USP 100mg
Each film coated tablet contains:
Sertraline Hydrochloride Tablets USP
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
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.