A) Azithromycin Tablets USP 250mg
B) Azithromycin Tablets USP 500mg
C) Azithromycin Tablets USP 600mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Azithromycin Tablets USP 250mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……250mg
Excipients ………………………………….…….……q. s
Colour: Titanium Dioxide USP
B) Azithromycin Tablets USP 500mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……500mg
Excipients ………………………………….…….……q. s
Colour: Iron oxide red
C) Azithromycin Tablets USP 600mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……600mg
Excipients ………………………………….…….……q. s
Colour: Iron oxide black
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……250mg
Excipients ………………………………….…….……q. s
Colour: Titanium Dioxide USP
B) Azithromycin Tablets USP 500mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……500mg
Excipients ………………………………….…….……q. s
Colour: Iron oxide red
C) Azithromycin Tablets USP 600mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……600mg
Excipients ………………………………….…….……q. s
Colour: Iron oxide black
THERAPEUTIC INDICATIONS:
Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Preserve in tight container.
A full course of antibiotic therapy in just 5 doses.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Take whole tablet with water.
Preserve in tight container.
A full course of antibiotic therapy in just 5 doses.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Azithromycin Tablets USP 500mg Technical Specification:
| Product Name: | Azithromycin Tablets USP 500mg |
| Brand Name: | Zithromin |
| Strength: | 250mg, 500mg, 600mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 100s |
| 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-biotics |
| Indication: | Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Azithromycin Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Azithromycin Tablets USP 500mg
Each Film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Anhydrous Azithromycin USP ……500mg
Excipients ………………………………….…….……q. s
Colour: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Preserve in tight container.
A full course of antibiotic therapy in just 5 doses.
Read enclosed leaflet before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
