| Product Name: | Gabapentin Tablets USP |
| Brand Name: | Generic |
| Strength: | 600mg, 800mg |
| Dosage Form: | Tablets (Film-coated) |
| 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: | Anticonvulsant, Central Nervous System |
| Indication: | Gabapentin is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Gabapentin Tablets USP 600mg
- Gabapentin Tablets USP 800mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Gabapentin Tablets USP 600mg
Each film-coated tablet contains:
Gabapentin USP………………….600mg
Excipients……………………………q.s.
Colour: Ponceau 4 R - Gabapentin Tablets USP 800mg
Each film-coated tablet contains:
Gabapentin USP…………………..800mg
Excipients…………………………….q.s.
Colour: Ferric Oxide Red
THERAPEUTIC INDICATIONS:
Gabapentin is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain. It is a first-line medication for the treatment of neuropathic pain caused by diabetic neuropathy, postherpetic neuralgia, and central pain.
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].
Protect from light and moisture.
Dosage: As directed by the Physician.