| Product Name: | Mebendazole Tablets USP |
| Brand Name: | Generic |
| Strength: | 100mg, 500mg, 1000mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 2s, 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anthelmintic, Antiparasitics |
| Indication: | Mebendazole is used to treat roundworm and whipworm infections. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Mebendazole Tablets USP 100mg
- Mebendazole Tablets USP 500mg
- Mebendazole Tablets USP 1000mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Mebendazole Tablets USP 100mg
Each uncoated tablet contains:
Mebendazole USP………………….100mg
Excipients……………………………….q.s. - Mebendazole Tablets USP 500mg
Each uncoated tablet contains:
Mebendazole USP……………………..500mg
Excipients…………………………………..q.s. - Mebendazole Tablets USP 1000mg
Each uncoated tablet contains:
Mebendazole USP……………………..1000mg
Excipients…………………………………..q.s.
THERAPEUTIC INDICATIONS:
Mebendazole is a medication used to treat a number of parasitic worm infestations. This includes ascariasis, pinworm infection, hookworm infections, guinea worm infections, hydatid disease, and giardia, among others.
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 the unit-dose blister pack in this bottle with the cap tightly secured till both tablets have been consumed.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician