| Product Name: | Baclofen Tablets USP |
| Brand Name: | Generic |
| Strength: | 10mg, 50mg |
| Dosage Form: | Tablets (Uncoated) |
| 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: | Skeletal muscle relaxant, Multiple sclerosis, Antispasmodic |
| Indication: | Baclofen is used to treat pain and certain types of spasticity (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Baclofen Tablets USP 10mg
B) Baclofen Tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- A) Baclofen Tablets USP 10mg
Each uncoated tablet contains:
Baclofen USP…………………..10mg
Excipients………………………….q.s.
Colour: Indigo carmine - B) Baclofen Tablets USP 50mg
Each uncoated tablet contains:
Baclofen USP…………………50mg
Excipients……………………….q.s.
Colour: Ponceau 2 R
THERAPEUTIC INDICATIONS:
Baclofen is a muscle relaxer and an antispasmodic agent.Baclofen is used to treat muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease.
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 a well-closed container as defined in the USP.
Dosage: As directed by the Physician.