Amoxicillin Capsules USP 500mg Technical Specification:

Product Name:Amoxicillin Capsules USP
Brand Name:Generic
Strength:500mg, 250mg
Dosage Form:Capsules (Hard gelatin)
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 & Penicillin
Indication: Amoxycillin to treat bacterial infections, such as chest infections and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers. It’s often prescribed for children, to treat ear infections and chest infections.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

a)  Amoxicillin Capsules USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Amoxicillin Capsules USP 500mg
Each hard gelatin Capsule contains:
Amoxicillin USP (Trihydrate)
Equivalent to Amoxicillin…………500mg
Excipients…………………………………q. s
Approved Colours are used in capsule shells.

THERAPEUTIC INDICATIONS:

Amoxycillin to treat bacterial infections, such as chest infections and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers. It’s often prescribed for children, to treat ear infections and chest 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].
Protect from Light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Amoxicillin Capsules USP 500mg
b) Amoxicillin Capsules USP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Amoxicillin Capsules USP 500mg
Each hard gelatin Capsule contains:
Amoxicillin USP (Trihydrate)
Equivalent to Amoxicillin…………500mg
Excipients…………………………………q. s
Approved Colours are used in capsule shells.


b) Amoxicillin Capsules USP 250mg
Each hard gelatin Capsule contains:
Amoxicillin USP (Trihydrate)
Equivalent to Amoxicillin……………250mg
Excipients……………………………………q. s
Approved Colours are used in capsule shells.

THERAPEUTIC INDICATIONS:

Amoxycillin to treat bacterial infections, such as chest infections and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers. It's often prescribed for children, to treat ear infections and chest 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].
Protect from Light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.