Label: NADOLOL tablet

  • NDC Code(s): 68001-630-00, 68001-631-00, 68001-632-00
  • Packager: BluePoint Laboratories
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 9, 2025

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  • SPL UNCLASSIFIED SECTION
    PRODUCT OVERVIEW: Nadalol Tablets USP, 20mg, 40mg and 80mg - (Nadolol USP) Rx Only
  • DESCRIPTION
    Nadolol tablets, USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-( tert-butyl-amino)-3-[(5,6,7,8-tetrahydro ...
  • CLINICAL PHARMACOLOGY
    Nadolol tablets, USP is a nonselective beta-adrenergic receptor blocking agent. Clinical pharmacology studies have demonstrated beta-blocking activity by showing (1) reduction in heart rate and ...
  • INDICATIONS AND USAGE
    Angina Pectoris - Nadolol tablets, USP is indicated for the long-term management of patients with angina pectoris. Hypertension - Nadolol tablets, USP is indicated for the treatment of ...
  • CONTRAINDICATIONS
    Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see - WARNINGS).
  • WARNINGS
    Cardiac Failure - Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate ...
  • PRECAUTIONS
    Impaired Renal Function - Nadolol should be used with caution in patients with impaired renal function (see - DOSAGE AND ADMINISTRATION). INFORMATION FOR PATIENTS - Interruption or ...
  • ADVERSE REACTIONS
    Most adverse effects have been mild and transient and have rarely required withdrawal of therapy. Cardiovascular - Bradycardia with heart rates of less than 60 beats per minute occurs commonly ...
  • OVERDOSAGE
    Nadolol can be removed from the general circulation by hemodialysis. In addition to gastric lavage, the following measures should be employed, as appropriate. In determining the duration of ...
  • DOSAGE AND ADMINISTRATION
    DOSAGE MUST BE INDIVIDUALIZED. NADOLOL TABLETS, USP MAY BE ADMINISTERED WITHOUT REGARD TO MEALS. Angina Pectoris - The usual initial dose is 40 mg Nadolol Tablets once daily. Dosage may be ...
  • HOW SUPPLIED
    All tablets are blue color with mottling, round, biconvex, having a score line on one side and debossed with the product code on the other. Nadolol Tablets are available in the following ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by - BEXIMCO PHARMACEUTICALS LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh - For BluePoint Laboratories - Revised: 12/2024
  • PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label
    NDC 68001-630-00 - Nadolol Tablets, USP - 20 mg - 100 Tablets - Rx only
  • PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label
    NDC 68001-631-00 - Nadolol Tablets, USP - 40 mg - 100 Tablets - Rx only
  • PRINCIPAL DISPLAY PANEL - 80 mg Tablet Bottle Label
    NDC 68001-632-00 - Nadolol Tablets, USP - 80 mg - 100 Tablets - Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information