GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Isosorbide Mononitrate Tablet USP 10mg
B) Isosorbide Mononitrate Tablet USP 20mg
B) Isosorbide Mononitrate Tablet USP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Isosorbide Mononitrate Tablet USP 10mg
Each Un-coated tablet contain:
Diluted Isosorbide Mononitrate USP
Eq. to Isosorbide Mononitrate......................10mg
Excipients………………………………………………..…..q.s.
B) Isosorbide Mononitrate Tablet USP 20mg
Each Un-coated tablet contain:
Diluted Isosorbide Mononitrate USP
Eq. to Isosorbide Mononitrate .....................20mg
Excipients………………………………………………..…..q.s.
Each Un-coated tablet contain:
Diluted Isosorbide Mononitrate USP
Eq. to Isosorbide Mononitrate......................10mg
Excipients………………………………………………..…..q.s.
B) Isosorbide Mononitrate Tablet USP 20mg
Each Un-coated tablet contain:
Diluted Isosorbide Mononitrate USP
Eq. to Isosorbide Mononitrate .....................20mg
Excipients………………………………………………..…..q.s.
THERAPEUTIC INDICATIONS:
Isosorbide mononitrate tablets are indicated for use in the treatment and prophylaxis of angina pectoris and as adjunctive therapy in congestive heart failure which does not respond adequately to cardiac glycosides and/or diuretics.
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).
Dosage: As directed by the Physician
Attach dispensing label here.
Dosage: As directed by the Physician
Attach dispensing label here.
Isosorbide Mononitrate Tablet USP 20mg Technical Specification:
| Product Name: | Isosorbide Mononitrate Tablet USP |
| Brand Name: | Generic |
| Strength: | 10mg, 20mg |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 150s |
| 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-angina |
| Indication: | Isosorbide mononitrate tablets are indicated for use in the treatment and prophylaxis of angina pectoris and as adjunctive therapy in congestive heart failure which does not respond adequately to cardiac glycosides and/or diuretics. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Isosorbide Mononitrate Tablet USP 10mg
- Isosorbide Mononitrate Tablet USP 20mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Isosorbide Mononitrate Tablet USP 10mg
Each Un-coated tablet contains:
Diluted Isosorbide Mononitrate USP
Eq. to Isosorbide Mononitrate………………….10mg
Excipients………………………………………………..…..q.s. - Isosorbide Mononitrate Tablet USP 20mg
Each Un-coated tablet contains:
Diluted Isosorbide Mononitrate USP
Eq. to Isosorbide Mononitrate …………………20mg
Excipients………………………………………………..…..q.s.
THERAPEUTIC INDICATIONS:
Isosorbide mononitrate tablets are indicated for use in the treatment and prophylaxis of angina pectoris and as adjunctive therapy in congestive heart failure which does not respond adequately to cardiac glycosides and/or diuretics.
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).
Dosage: As directed by the Physician
Attach dispensing label here.
