GENERIC NAME OF THE MEDICINAL PRODUCT:
b) Oseltamivir Phosphate Capsule USP 75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Hard-gelatin capsule contains:
Oseltamivir Phosphate USP…………………45.5mg
Equivalent to oseltamivir…………………….30mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell.
b) Oseltamivir Phosphate Capsule USP 75mg
Each Hard-gelatin capsule contains:
Oseltamivir Phosphate USP…………………98.5mg
Equivalent to oseltamivir…………………….75mg
Excipients……………………………. q.s.
Approved Colours used in empty capsule shell.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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:
Dosage: As directed by the Physician.
Attach the dispensing label as per the end country
Oseltamivir Phosphate Capsule USP 75mg Technical Specification:
Product Name: | Oseltamivir Phosphate Capsule USP 75mg |
Brand Name: | Generics |
Strength: | (30mg), (75mg) |
Dosage Form: | Capsule (Hard-Gelatine) |
Route of Administration: | Via oral Route |
Packing: | 10s, 30s, 90s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antiviral agents, Anti-influenza |
Indication: | oseltamivir phosphate is an oral anti-viral drug approved for the treatment of acute, uncomplicated influenza in patients 2 weeks of age and older whose flu symptoms have not lasted more than two days. |
Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Oseltamivir Phosphate Capsule USP 75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Oseltamivir Phosphate Capsule USP 75mg
Each Hard-gelatin capsule contains:
Oseltamivir Phosphate USP…………………98.5mg
Equivalent to oseltamivir…………………….75mg
Excipients……………………………. q.s.
Approved Colours used in the empty capsule shell.
THERAPEUTIC INDICATIONS:
Oseltamivir phosphate is an oral anti-viral drug approved for the treatment of acute, uncomplicated influenza in patients 2 weeks of age and older whose flu symptoms have not lasted more than two days.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the 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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.
Attach the dispensing label as per the end country.