| Product Name: | Duloxetine HCL Gestro-Resistant Tablets IP |
| Brand Name: | Generic |
| Strength: | 20mg, 30mg, 40mg, 60mg |
| Dosage Form: | Tablets (Enteric coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antidepressants |
| Indication: | Duloxetine is used to treat depression and anxiety. It is also used to help relieve nerve pain in people with diabetes or ongoing pain due to medical conditions such as arthritis, chronic back pain, or fibromyalgia |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Duloxetine HCL Gestro-Resistant Tablets IP 20mg
- Duloxetine HCL Gestro-Resistant Tablets IP 30mg
- Duloxetine HCL Gestro-Resistant Tablets IP 40mg
- Duloxetine HCL Gestro-Resistant Tablets IP 60mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Duloxetine HCL Gestro-Resistant Tablets IP 20mg
Each Enteric coated tablet contains:
Duloxetine Hydrochloride IP
Equivalent to Duloxetine …………….20mg
Excipients………………………………………..q.s.
Color: Titanium Dioxide IP - Duloxetine HCL Gestro-Resistant Tablets IP 30mg
Each Enteric coated tablet contains:
Duloxetine Hydrochloride IP
Equivalent to Duloxetine …………….30mg
Excipients………………………………………..q.s.
Color: Red Oxide of Iron - Duloxetine HCL Gestro-Resistant Tablets IP 40mg
Each Enteric coated tablet contains:
Duloxetine Hydrochloride IP
Equivalent to Duloxetine …………….40mg
Excipients………………………………………..q.s.
Color: Yellow Oxide of Iron IP - Duloxetine HCL Gestro-Resistant Tablets IP 60mg
Each Enteric coated tablet contains:
Duloxetine Hydrochloride IP
Equivalent to Duloxetine …………….60mg
Excipients………………………………………..q.s.
Color: Lake of Tartrazine
THERAPEUTIC INDICATIONS:
Duloxetine is used to treat depression and anxiety. It is also used to help relieve nerve pain (peripheral neuropathy) in people with diabetes or ongoing pain due to medical conditions such as arthritis, chronic back pain, or fibromyalgia (a condition that causes widespread pain)
CAUTION & SCHEDULE:
CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Store in a cool, dry & dark place
Protect from Light & moisture.
Dosage: As directed by the Physician