Clarithromycin Tablets USP 500mg Technical Specification:
| Product Name: | Clarithromycin Tablets USP 500mg |
| Brand Name: | Generic |
| Strength: | (250mg), (500mg) |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 150s |
| 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-bacterial, Antibiotics |
| Indication: | Clarithromycin is a macrolide antibiotic that fights bacteria in your body. Clarithromycin is used to treat many different types of bacterial infections affecting the skin and respiratory system. Clarithromycin is also used together with other medicines to treat stomach ulcers caused by Helicobacter pylori. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Clarithromycin Tablets USP 250mg
- Clarithromycin Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Clarithromycin Tablets USP 250mg
Each Film-coated tablet contains:
Clarithromycin USP………………………..250mg
Excipients………………………………………..q.s.
Color: Titanium Dioxide USP
- Clarithromycin Tablets USP 500mg
Each Film-coated tablet contains:
Clarithromycin USP …………………………500mg
Excipients………………………………………..q.s.
Color: Red Oxide of Iron USP
THERAPEUTIC INDICATIONS:
Clarithromycin is a macrolide antibiotic that fights bacteria in your body. Clarithromycin is used to treat many different types of bacterial infections affecting the skin and respiratory system. Clarithromycin is also used together with other medicines to treat stomach ulcers caused by Helicobacter pylori.
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).
Store in a tight, light-resistant container.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Clarithromycin Tablets USP 250mg
B) Clarithromycin Tablets USP 500mg
B) Clarithromycin Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Clarithromycin Tablets USP 250mg
Each Film-coated tablet contain:
Clarithromycin USP……………..............250mg
Excipients………………………………………..q.s.
Color: Titanium Dioxide USP
B) Clarithromycin Tablets USP 500mg
Each Film-coated tablet contains:
Clarithromycin USP …………………………500mg
Excipients………………………………………..q.s.
Color: Red Oxide of Iron USP
Each Film-coated tablet contain:
Clarithromycin USP……………..............250mg
Excipients………………………………………..q.s.
Color: Titanium Dioxide USP
B) Clarithromycin Tablets USP 500mg
Each Film-coated tablet contains:
Clarithromycin USP …………………………500mg
Excipients………………………………………..q.s.
Color: Red Oxide of Iron USP
THERAPEUTIC INDICATIONS:
Clarithromycin is a macrolide antibiotic that fights bacteria in your body. Clarithromycin is used to treat many different types of bacterial infections affecting the skin and respiratory system. Clarithromycin is also used together with other medicines to treat stomach ulcers caused by Helicobacter pylori.
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.
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).
Store in tight, light-resistant container.
Dosage: As directed by the Physician.
Store in tight, light-resistant container.
Dosage: As directed by the Physician.
