Irbesartan Tablets USP 300mg Technical Specification:
| Product Name: | Irbesartan Tablets USP |
| Brand Name: | Generic |
| Strength: | 75mg, 150mg, 300mg |
| Dosage Form: | Tablets (Film coated) |
| 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: | Antihypertensive |
| Indication: | Irbesartan is used alone or together with other medicines to treat high blood pressure (hypertension). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Irbesartan Tablets USP 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Irbesartan Tablets USP 300mg
Each film coated tablet contains:
Irbesartan USP…………………..300mg
Excipients…………………………..q.s.
Colour: Quinoline yellow WS
THERAPEUTIC INDICATIONS:
Acamprosate is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Acamprosate works by restoring the natural balance of chemicals in the brain (neurotransmitters).Before starting this medication, you should no longer be drinking alcohol. Acamprosate has not been shown to work well if you are still drinking alcohol when you start taking it.
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].
Dispense in tight container.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Irbesartan Tablets USP 75mg
B) Irbesartan Tablets USP 150mg
C) Irbesartan Tablets USP 300mg
B) Irbesartan Tablets USP 150mg
C) Irbesartan Tablets USP 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Irbesartan Tablets USP 75mg
Each film coated tablet contains:
Irbesartan USP……………….75mg
Excipients……………………….q.s.
Colour: Lake of Erythrosine
B) Irbesartan Tablets USP 150mg
Each film coated tablet contains:
Irbesartan USP…………….150mg
Excipients…………………….q.s.
Colour: Ponceau 4 R
C) Irbesartan Tablets USP 300mg
Each film coated tablet contains:
Irbesartan USP…………………..300mg
Excipients…………………………..q.s.
Colour: Quinoline yellow WS
Each film coated tablet contains:
Irbesartan USP……………….75mg
Excipients……………………….q.s.
Colour: Lake of Erythrosine
B) Irbesartan Tablets USP 150mg
Each film coated tablet contains:
Irbesartan USP…………….150mg
Excipients…………………….q.s.
Colour: Ponceau 4 R
C) Irbesartan Tablets USP 300mg
Each film coated tablet contains:
Irbesartan USP…………………..300mg
Excipients…………………………..q.s.
Colour: Quinoline yellow WS
THERAPEUTIC INDICATIONS:
Acamprosate is used along with counseling and support to help people who are alcohol dependent not drink alcohol. Acamprosate works by restoring the natural balance of chemicals in the brain (neurotransmitters).Before starting this medication, you should no longer be drinking alcohol. Acamprosate has not been shown to work well if you are still drinking alcohol when you start taking it.
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.
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].
Dispense in tight container.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Dispense in tight container.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
