GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Cefadroxil for Oral Suspension USP 125mg/5ml
b) Cefadroxil for Oral Suspension USP 250mg/5ml
c) Cefadroxil for Oral Suspension USP 500mg/5ml
b) Cefadroxil for Oral Suspension USP 250mg/5ml
c) Cefadroxil for Oral Suspension USP 500mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Cefadroxil for Oral Suspension USP 125mg/5ml
Each 5ml of reconstituted suspension contains:
Cefadroxil USP
Equivalent to anhydrous Cefadroxil…………….125mg
Excipients…………………………………………………….q. s
Color: Lake of Sunset Yellow
b) Cefadroxil for Oral Suspension USP 250mg/5ml
Each 5ml of reconstituted suspension contains:
Cefadroxil USP
Equivalent to anhydrous Cefadroxil…………..250mg
Excipients…………………………………………………..q. s
Color: Sunset Yellow FCF
c) Cefadroxil for Oral Suspension USP 500mg/5ml
Each 5ml of reconstituted suspension contains:
Cefadroxil USP
Equivalent to anhydrous Cefadroxil………………..500mg
Excipients………………………………………………………q. s
Color: Caramel
Each 5ml of reconstituted suspension contains:
Cefadroxil USP
Equivalent to anhydrous Cefadroxil…………….125mg
Excipients…………………………………………………….q. s
Color: Lake of Sunset Yellow
b) Cefadroxil for Oral Suspension USP 250mg/5ml
Each 5ml of reconstituted suspension contains:
Cefadroxil USP
Equivalent to anhydrous Cefadroxil…………..250mg
Excipients…………………………………………………..q. s
Color: Sunset Yellow FCF
c) Cefadroxil for Oral Suspension USP 500mg/5ml
Each 5ml of reconstituted suspension contains:
Cefadroxil USP
Equivalent to anhydrous Cefadroxil………………..500mg
Excipients………………………………………………………q. s
Color: Caramel
THERAPEUTIC INDICATIONS:
Cefadroxil is used to treat certain infections caused by bacteria such as infections of the skin, throat, tonsils, and urinary tract. Cefadroxil is in a class of medications called cephalosporin antibiotics. It works by killing bacteria.
DIRECTION FOR RECONSTITUTION:
Shake the bottle well to loosen the powder.
Slowly add boiled and cooled water up to the mark on the bottle and shake well.
Add water if necessary to adjust the volume up to the mark.
The reconstituted suspension should be stored in a cool place preferably in the refrigerator & should be used within four days of preparation.
Slowly add boiled and cooled water up to the mark on the bottle and shake well.
Add water if necessary to adjust the volume up to the mark.
The reconstituted suspension should be stored in a cool place preferably in the refrigerator & should be used within four days of preparation.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
THE RECONSTITUTED SUSPENSION SHOULD BE USED WITHIN FOUR DAYS OF PREPARATION. SHAKE WELL CONSTITUTED SUSPENSION BEFORE USE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
THE RECONSTITUTED SUSPENSION SHOULD BE USED WITHIN FOUR DAYS OF PREPARATION. SHAKE WELL CONSTITUTED SUSPENSION BEFORE USE.
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].
Protect from Light and moisture.
DOSAGE: As directed by the Physician
Attach dispensing label as per end country.
Protect from Light and moisture.
DOSAGE: As directed by the Physician
Attach dispensing label as per end country.
Cefadroxil for Oral Suspension USP 125mg/5ml Technical Specification:
| Product Name: | Cefadroxil for Oral Suspension USP |
| Brand Name: | Generic |
| Strength: | 125mg/5ml, 250mg/5ml, 500mg/5ml |
| Dosage Form: | Dry Syrup (Oral Suspension) |
| Route of Administration: | Via Oral Route |
| Packing: | 60ml |
| 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: | Cefadroxil is used to treat certain infections caused by bacteria such as infections of the skin, throat, tonsils, and urinary tract. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cefadroxil for Oral Suspension USP 125mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Cefadroxil for Oral Suspension USP 125mg/5ml
Each 5ml of reconstituted suspension contains:
Cefadroxil USP
Equivalent to anhydrous Cefadroxil…………….125mg
Excipients…………………………………………………….q. s
Color: Lake of Sunset Yellow
THERAPEUTIC INDICATIONS:
Cefadroxil is used to treat certain infections caused by bacteria such as infections of the skin, throat, tonsils, and urinary tract. Cefadroxil is in a class of medications called cephalosporin antibiotics. It works by killing bacteria.
DIRECTION FOR RECONSTITUTION:
Shake the bottle well to loosen the powder. Slowly add boiled and cooled water up to the mark on the bottle and shake well. Add water if necessary to adjust the volume up to the mark. The reconstituted suspension should be stored in a cool place preferably in the refrigerator & should be used within four days of preparation.
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
THE RECONSTITUTED SUSPENSION SHOULD BE USED WITHIN FOUR DAYS OF PREPARATION.
SHAKE WELL CONSTITUTED SUSPENSION BEFORE USE.
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].
Protect from Light and moisture.
DOSAGE: As directed by the Physician.
Attach dispensing label as per end country.
