Label: PROPRANOLOL HYDROCHLORIDE tablet

  • NDC Code(s): 0115-1659-01, 0115-1659-03, 0115-1660-01, 0115-1660-03, view more
  • Packager: Amneal Pharmaceuticals of New York LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 12, 2019

If you are a consumer or patient please visit this version.

  • DESCRIPTION
    Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its ...
  • CLINICAL PHARMACOLOGY
    General - Propranolol is a nonselective beta-adrenergic receptor blocking agent possessing no other autonomic nervous system activity. It specifically competes with beta-adrenergic receptor ...
  • INDICATIONS AND USAGE
    Hypertension - Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly ...
  • CONTRAINDICATIONS
    Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol ...
  • WARNINGS
    Angina Pectoris - There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when ...
  • PRECAUTIONS
    General - Propranolol should be used with caution in patients with impaired hepatic or renal function. Propranolol is not indicated for the treatment of hypertensive ...
  • ADVERSE REACTIONS
    The following adverse events were observed and have been reported in patients using propranolol. Cardiovascular: Bradycardia; congestive heart failure; intensification of AV block; hypotension ...
  • OVERDOSAGE
    Propranolol is not significantly dialyzable. In the event of overdosage or exaggerated response, the following measures should be employed: General: If ingestion is or may have been recent ...
  • DOSAGE AND ADMINISTRATION
    General - Because of the variable bioavailability of propranolol, the dose should be individualized based on response. Hypertension - The usual initial dosage is 40 mg propranolol hydrochloride ...
  • HOW SUPPLIED
    Propranolol Hydrochloride Tablets, USP 10 mg are 9/32", scored, round, orange tablets imprinted “DAN 5554” and “10” supplied in bottles of 100 and 1000. Propranolol Hydrochloride Tablets, USP 20 ...
  • PRINCIPAL DISPLAY PANEL - 10 mg
    NDC 0115-1659-01 - Propranolol - Hydrochloride - Tablets, USP - 10 mg - Rx only - 100 Tablets
  • PRINCIPAL DISPLAY PANEL - 20 mg
    NDC 0115-1660-01 - Propranolol - Hydrochloride - Tablets, USP - 20 mg - Rx only - 100 Tablets
  • PRINCIPAL DISPLAY PANEL - 40 mg
    NDC 0115-1661-01 - Propranolol - Hydrochloride - Tablets, USP - 40 mg - Rx only - 100 Tablets
  • PRINCIPAL DISPLAY PANEL - 80 mg
    NDC 0115-1662-01 - Propranolol - Hydrochloride - Tablets, USP - 80 mg - Rx only - 100 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information