Cefuroxime Axetil Tablets USP 125mg
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Cefuroxime Axetil Tablets USP 125mg Technical Specification:

Product Name: Cefuroxime Axetil Tablets USP 125mg
Brand Name: Generic
Strength: (500mg), (250mg), (125mg)
Dosage Form: Tablets
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: β-lactam Antibiotic, Anti-bacterial & Cephalosporins.
Indication: Cefuroxime is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cefuroxime Axetil Tablets USP 500mg
    Each film-coated tablet contains:
    Cefuroxime Axetil USP
    Equivalent to Cefuroxime…………..500mg
    Excipients………………………………….q.s.
    Color: Red oxide of iron
  • Cefuroxime Axetil Tablets USP 250mg
    Each film-coated tablet contains:
    Cefuroxime Axetil USP
    Equivalent to Cefuroxime ………..250mg
    Excipients………………………………….q.s.
    Color: Tartrazine
  • Cefuroxime Axetil Tablets USP 125mg
    Each film-coated tablet contains:
    Cefuroxime Axetil USP
    Equivalent to Cefuroxime ………..125mg
    Excipients………………………………….q.s.
    Color: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Cefuroxime is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.

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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

DOSAGE: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Cefuroxime Axetil Tablets USP 500mg
b) Cefuroxime Axetil Tablets USP 250mg
c) Cefuroxime Axetil Tablets USP 125mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Cefuroxime Axetil Tablets USP 500mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime…………..500mg
Excipients………………………………….q.s.
Color: Red oxide of iron

b) Cefuroxime Axetil Tablets USP 250mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..250mg
Excipients………………………………….q.s.
Color: Tartrazine

c) Cefuroxime Axetil Tablets USP 125mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..125mg
Excipients………………………………….q.s.
Color: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Cefuroxime is used to treat a wide variety of bacterial infections. This medication is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.

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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
DOSAGE: As directed by the Physician.