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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Oseltamivir Phosphate Capsule USP 30mg
b) Oseltamivir Phosphate Capsule USP 75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Oseltamivir Phosphate Capsule USP 30mg
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:

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 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: 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 from moisture.
Dosage: As directed by the Physician.
Attach the dispensing label as per the end country