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