Azithromycin Tablets USP 250mg Technical Specification:

Product Name:Azithromycin Tablets USP 250mg
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 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • 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

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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Azithromycin Tablets USP 250mg
B) Azithromycin Tablets USP 500mg
C) Azithromycin Tablets USP 600mg

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

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.