| Product Name: | Phenytoin Sodium Chewable Tablets USP |
| Brand Name: | Generic |
| Strength: | 100mg,300mg |
| Dosage Form: | Tablets (Chewable) |
| 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: | Anticonvulsants, Antiepileptic |
| Indication: | Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Phenytoin Sodium Chewable Tablets USP 100mg
- Phenytoin Sodium Chewable Tablets USP 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Phenytoin Sodium Chewable Tablets USP 100mg
Each Chewable Tablet contains:
Phenytoin Sodium USP
Equivalent to Phenytoin………………………………100mg
Excipients…………………………………………………….q.s
Colour: FD&C yellow No. 6, Aluminum Lake - Phenytoin Sodium Chewable Tablets USP 300mg
Each Chewable Tablet contains:
Phenytoin Sodium USP
Equivalent to Phenytoin………………………………300mg
Excipients…………………………………………………….q.s
Colour: FD&C yellow No. 6, Aluminum Lake
THERAPEUTIC INDICATIONS:
Phenytoin is used to control certain type of seizures, and to treat and prevent seizures that may begin during or after surgery to the brain or nervous system. Phenytoin is in a class of medications called anticonvulsants.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
TABLET CAN BE EITHER CHEWED THROUGHTLY BEFORE BEING SWALLOWED OR SWALLOWED WHOLE.
Warning: To be sold by retail on the prescription of a neurologist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.