GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Ampicillin Capsules USP 250mg
b) Ampicillin Capsules USP 500mg
b) Ampicillin Capsules USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Ampicillin Capsules USP 250mg
Each hard gelatin Capsule contains:
Ampicillin Trihydrate USP
Equivalent to Ampicillin…………….250mg
Excipients……………………………………q. s
Approved colours used in capsule shell.
b) Ampicillin Capsules USP 500mg
Each hard gelatin Capsule contains:
Ampicillin Trihydrate USP
Equivalent to Ampicillin…………………500mg
Excipients………………………………………q.s
Approved colours used in capsule shell.
Each hard gelatin Capsule contains:
Ampicillin Trihydrate USP
Equivalent to Ampicillin…………….250mg
Excipients……………………………………q. s
Approved colours used in capsule shell.
b) Ampicillin Capsules USP 500mg
Each hard gelatin Capsule contains:
Ampicillin Trihydrate USP
Equivalent to Ampicillin…………………500mg
Excipients………………………………………q.s
Approved colours used in capsule shell.
THERAPEUTIC INDICATIONS:
Ampicillin is an antibiotic used to prevent and treat a number of bacterial infections, such as respiratory tract infections, urinary tract infections, meningitis, salmonellosis, and endocarditis. It may also be used to prevent group B streptococcal infection in newborns.
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) [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.
Ampicillin Capsules USP 500mg Technical Specification:
| Product Name: | Ampicillin Capsules USP |
| Brand Name: | Generic |
| Strength: | 250mg, 500mg |
| 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: | Ampicillin is used to treat certain infections that are caused by bacteria such as meningitis; and infections of the throat, sinuses, lungs, reproductive organs, urinary tract, and gastrointestinal tract. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Ampicillin Capsules USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Ampicillin Capsules USP 500mg
Each hard gelatin Capsule contains:
Ampicillin Trihydrate USP
Equivalent to Ampicillin…………….500mg
Excipients……………………………………q. s
Approved colors used in the capsule shell.
THERAPEUTIC INDICATIONS:
Ampicillin is an antibiotic used to prevent and treat a number of bacterial infections, such as respiratory tract infections, urinary tract infections, meningitis, salmonellosis, and endocarditis. It may also be used to prevent group B streptococcal infection in newborns.
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.
Keep the 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.
