Paroxetine Hydrochloride Tablets USP 10mg
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Paroxetine Hydrochloride Tablets USP 10mg Technical Specification:

Product Name:                               Paroxetine Hydrochloride Tablets USP 10mg
Brand Name:Generics
Strength:10mg, 20mg, 30mg, 40mg
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: Paroxetine is used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic 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:

  • Paroxetine Hydrochloride Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Paroxetine Hydrochloride Tablets USP 10mg
    Each film coated tablet contains:
    Paroxetine Hydrochloride USP
    Equivalent to Paroxetine………………10mg
    Excipients…………………………………….q.s
    Colours: Indigo Carmine Lake

THERAPEUTIC INDICATIONS:

Paroxetine is used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

*Not suitable for children under 15 years.

*(Treat) Suicidality & Antidepressant Drugs

Read enclosed leaflet before use.

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

Warning: Patients with major depressive disorders (MDD), both adult & pediatric, may experience worsening of their depression and/or the emergency of suicidal ideation & behaviour.

Keep medicine out of reach of children.

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. Paroxetine Hydrochloride Tablets USP 10mg
B. Paroxetine Hydrochloride Tablets USP 20mg
C. Paroxetine Hydrochloride Tablets USP 30mg
D. Paroxetine Hydrochloride Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Paroxetine Hydrochloride Tablets USP 10mg
Each film coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine……………...10mg
Excipients…………………………………….q.s
Colours: Indigo Carmine Lake

B. Paroxetine Hydrochloride Tablets USP 20mg
Each film coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine…………………20mg
Excipients…………………………………………q.s
Colours: Titanium Dioxide B.P

C. Paroxetine Hydrochloride Tablets USP 30mg
Each film coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine…………………...30m
Excipients………………………………………...q.s
Colours: Brilliant Blue

D. Paroxetine Hydrochloride Tablets USP 40mg
Each film coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine………………….40mg
Excipients…………………………………………q.s
Colours: Sunset Yellow

THERAPEUTIC INDICATIONS:

Paroxetine is used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
*Not suitable for children under 15 years.
*(Treat) Suicidality & Antidepressant Drugs
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
WARNING: Patients with major depressive disorders (MDD), both adult & pediatric, may experience worsening of their depression and/or the emergency of suicidal ideation & behaviour.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

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.