Citalopram Tablets USP 10mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Citalopram Tablets USP 5mg
B) Citalopram Tablets USP 10mg
C) Citalopram Tablets USP 20mg
D) Citalopram Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Citalopram Tablets USP 5mg
Each film-coated tablet contains:
Citalopram Hydrobromide USP
Equivalent to Citalopram…………….5mg
Excipients……………………………………. q.s.
Colour: Ferric oxide yellow

B) Citalopram Tablets USP 10mg
Each film-coated tablet contains:
Citalopram Hydrobromide USP
Equivalent to Citalopram…………10mg
Excipients………………………………. q.s.
Colour: Lake of quinoline yellow

 C) Citalopram Tablets USP 20mg
Each film-coated tablet contains:
Citalopram Hydrobromide IP
Equivalent to Citalopram……….20mg
Excipients………………………………. q.s.
Colour: Fast green FCF

D) Citalopram Tablets USP 40mg
Each film-coated tablet contains:
Citalopram Hydrobromide USP
Equivalent to Citalopram………….40mg
Excipients…………………………………. q.s.
Colour: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Citalopram is an antidepressant of the selective serotonin reuptake inhibitor class. It is used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, and social phobia. The antidepressant effects may take one to four weeks to occur.

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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container. Protect from light and moisture.
Dosage: As directed by the Physician. Attach dispensing label as per end country.

Citalopram Tablets USP 10mg Technical Specification:

Product Name:Citalopram Tablets USP
Brand Name:Generic
Strength:5mg, 10mg, 20mg, 40mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 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: Citalopram is used to treat depression, including major depressive disorder (MDD).
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Citalopram Tablets USP 5mg
  • Citalopram Tablets USP 10mg
  • Citalopram Tablets USP 20mg
  • Citalopram Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Citalopram Tablets USP 5mg
    Each film-coated tablet contains:
    Citalopram Hydrobromide USP
    Equivalent to Citalopram…………….5mg
    Excipients……………………………………. q.s.
    Colour: Ferric oxide yellow
  • Citalopram Tablets USP 10mg
    Each film-coated tablet contains:
    Citalopram Hydrobromide USP
    Equivalent to Citalopram…………10mg
    Excipients………………………………. q.s.
    Colour: Lake of quinoline yellow
  •  Citalopram Tablets USP 20mg
    Each film-coated tablet contains:
    Citalopram Hydrobromide IP
    Equivalent to Citalopram……….20mg
    Excipients………………………………. q.s.
    Colour: Fast green FCF
  • Citalopram Tablets USP 40mg
    Each film-coated tablet contains:
    Citalopram Hydrobromide USP
    Equivalent to Citalopram………….40mg
    Excipients…………………………………. q.s.
    Colour: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Citalopram is an antidepressant of the selective serotonin reuptake inhibitor class. It is used to treat the major depressive disorder, obsessive-compulsive disorder, panic disorder, and social phobia. The antidepressant effects may take one to four weeks to occur.

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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.