GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Paroxetine Hydrochloride Tablets USP 20mg
C. Paroxetine Hydrochloride Tablets USP 30mg
D. Paroxetine Hydrochloride Tablets USP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
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:
CAUTION & WARNING:
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:
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.
Paroxetine Hydrochloride Tablets USP 20mg Technical Specification:
Product Name: | Paroxetine Hydrochloride Tablets USP 20mg |
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 it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Paroxetine Hydrochloride Tablets USP 10mg
- Paroxetine Hydrochloride Tablets USP 20mg
- Paroxetine Hydrochloride Tablets USP 30mg
- Paroxetine Hydrochloride Tablets USP 40mg
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 - 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 - Paroxetine Hydrochloride Tablets USP 30mg
Each film-coated tablet contains:
Paroxetine Hydrochloride USP
Equivalent to Paroxetine……………………30mg
Excipients…………………………………………q.s
Colours: Brilliant Blue - 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:
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 below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.