GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Fluoxetine Tablets IP 10mg
B) Fluoxetine Tablets IP 20mg
C) Fluoxetine Tablets IP 40mg
D) Fluoxetine Tablets IP 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Fluoxetine Tablets IP 10mg
Each film coated tablet contains:
Fluoxetine Hydrochloride IP
Equivalent to Fluoxetine……………...10mg
Excipients………………………………………….q.s
Colour: Titanium Dioxide IP

B) Fluoxetine Tablets IP 20mg
Each film coated tablet contains:
Fluoxetine Hydrochloride IP
Equivalent to Fluoxetine………………...20mg
Excipients……………………………………………q.s
Colour: Ponceau 4 R

C) Fluoxetine Tablets IP 40mg
Each film coated tablet contains:
Fluoxetine Hydrochloride IP
Equivalent to Fluoxetine………………….40mg
Excipients…………………………………………q.s
Colour: Sunset yellow

D) Fluoxetine Tablets IP 60mg
Each film coated tablet contains:
Fluoxetine Hydrochloride IP
Equivalent to Fluoxetine………………….60mg
Excipients…………………………………….q.s
Colour: Lake of indigo carmine

THERAPEUTIC INDICATIONS:

Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorder, bulimia nervosa, panic disorder, and premenstrual dysphoric 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.

Fluoxetine Tablets IP 40mg Technical Specification:

Product Name: Fluoxetine Tablets IP
Brand Name: Generic
Strength: 10mg, 20mg, 40mg, 60mg
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: Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs).
Storage: Store below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • A) Fluoxetine Tablets IP 10mg
  • B) Fluoxetine Tablets IP 20mg
  • C) Fluoxetine Tablets IP 40mg
  • D) Fluoxetine Tablets IP 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • A) Fluoxetine Tablets IP 10mg
    Each film coated tablet contains:
    Fluoxetine Hydrochloride IP
    Equivalent to Fluoxetine………………10mg
    Excipients………………………………………….q.s
    Colour: Titanium Dioxide IP
  • B) Fluoxetine Tablets IP 20mg
    Each film coated tablet contains:
    Fluoxetine Hydrochloride IP
    Equivalent to Fluoxetine………………..20mg
    Excipients……………………………………………q.s
    Colour: Ponceau 4 R
  • C) Fluoxetine Tablets IP 40mg
    Each film coated tablet contains:
    Fluoxetine Hydrochloride IP
    Equivalent to Fluoxetine………………….40mg
    Excipients…………………………………………q.s
    Colour: Sunset yellow
  • D) Fluoxetine Tablets IP 60mg
    Each film coated tablet contains:
    Fluoxetine Hydrochloride IP
    Equivalent to Fluoxetine………………….60mg
    Excipients…………………………………….q.s
    Colour: Lake of indigo carmine

THERAPEUTIC INDICATIONS:

  • Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorder, bulimia nervosa, panic disorder, and premenstrual dysphoric 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.