Ivermectin Tablet USP 3mg Technical Specification:
| Product Name: | Ivermectin Tablet USP |
| Brand Name: | Iverotaj |
| Strength: | 3mg, 6mg, 12mg |
| Dosage Form: | Un-coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 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: | Anti-parasitic |
| Indication: | Ivermectin is an antiparasitic drug used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies. |
| Storage: | Store at a temperature not exceeding 25°C. Keep in cool & Dry place, Protect from light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ivermectin Tablets USP 3mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ivermectin Tablets USP 3mg
Each uncoated tablet contains:
Ivermectin USP …….………….3mg
Excipients……………………………q.s.
THERAPEUTIC INDICATIONS:
Ivermectin is an antiparasitic drug used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
SHOULD BE TAKEN ON AN EMPTY STOMACH
NOT SUITABLE FOR CHILDREN UNDER 5 YEARS
Preserve in tight container.
WARNING: To be sold by retail on the prescription of a Registered Medical Prescription only.
STORAGE & DOSAGE:
Storage: Store at 25°C. Excursions permitted within 15°C to 30°C.
Keep medicine out of reach of children.
Read the package leaflet before use.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Ivermectin Tablets USP 6mg
C) Ivermectin Tablets USP 12mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Ivermectin USP …….………….3mg
Excipients……………………………q.s.
B) Ivermectin Tablets USP 6mg
Each uncoated tablet contains:
Ivermectin USP …..…………..6mg
Excipients……………………………q.s.
C) Ivermectin Tablets USP 12mg
Each uncoated tablet contains:
Ivermectin USP ……………...12mg
Excipients……………………………q.s.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
SHOULD BE TAKEN ON AN EMPTY STOMACH
NOT SUITABLE FOR CHILDREN UNDER 5 YEARS
Preserve in tight container.
WARNING: To be sold by retail on the prescription of a Registered Medical Prescription only.
STORAGE & DOSAGE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read the package leaflet before use.
Dosage: As directed by the Physician.

