| Product Name: | Nadolol Tablets USP |
| Brand Name: | Generic |
| Strength: | (20mg), (40mg), (80mg) |
| Dosage Form: | Tablets |
| 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, Antianginal |
| Indication: | Nadolol is used alone or in combination with other medications to treat high blood pressure. It is also used to prevent angina (chest pain). Nadolol is in a class of medications called beta-blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in a dry place. Protect from moisture, freezing, and excessive heat. |
Nadolol Tablets USP 40mg Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Nadolol Tablets USP 20mg
B. Nadolol Tablets USP 40mg
C. Nadolol Tablets USP 80mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Nadolol Tablets USP 20mg
Each tablet contains:
Nadolol USP………20mg
Excipients………….q.s
Color: Sunset yellow FCF
B. Nadolol Tablets USP 40mg
Each tablet contains:
Nadolol USP……….40mg
Excipients…………… q.s
Color: Brilliant Blue FCF
C. Nadolol Tablets USP 80mg
Each tablet contains:
Nadolol USP…………80mg
Excipients……………….q.s
Color: Carmoisine
THERAPEUTIC INDICATIONS:
Nadolol is used alone or in combination with other medications to treat high blood pressure. It is also used to prevent angina (chest pain). Nadolol is in a class of medications called beta-blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required.
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).
Store at 20° to 25°C (68° to 77°F). Store in a dry place. Protect from moisture, freezing, and excessive heat.
Dosage: As directed by the Physician.