Label: PROPRANOLOL HYDROCHLORIDE - propranolol hydrochloride tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 02/12

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    hydrochloride(Propranolol  is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are:

    propranololhclusp

    Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80.

    Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration.

    The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain  and C yellow No.6 Aluminium Lake and Color D and C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD and C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D and C Red No. 30 Lake.

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  • 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 hydrochloride.

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  • 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; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type.

    Central Nervous System: Lightheadedness, mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics. For immediate-release formulations, fatigue, lethargy, and vivid dreams appear dose-related.

    Gastrointestinal: Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.

    Allergic: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, pharyngitis and agranulocytosis; erythematous rash, fever combined with aching and sore throat; laryngospasm, and respiratory distress.

    Respiratory: Bronchospasm.

    Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.

    Autoimmune: Systemic lupus erythematosus (SLE).

    Skin and mucous membranes: Stevens-Johnson Syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasiform rashes. Oculomucocutaneous syndrome involving the skin, serous membranes and conjunctivae reported for a beta-blocker (practolol) have not been associated with propranolol.

    Genitourinary: Male impotence; Peyronie’s disease.

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  • 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, evacuate gastric contents, taking care to prevent pulmonary aspiration.

    Supportive Therapy: Hypotension and bradycardia have been reported following propranolol overdose and should be treated appropriately. Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a propranolol overdose. Glucagon should be administered as 50-150 mcg/kg intravenously followed by continuous drip of 1-5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine or phosphodiesterase inhibitors may also be useful. Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.

    The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored. Isoproterenol and aminophylline may be used for bronchospasm.

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  • HOW SUPPLIED

    Propranolol hydrochloride tablets, USP are supplied as follows:

    10mg: Each tablet is an orange colored, round, biconvex tablet, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side.

    Each 10 mg tablet contains 10 mg propranolol hydrochloride USP and is supplied in the following packages sizes:

    Bottles of 30 tablets                                 NDC 23155-110-03

    Bottles of 60 tablets                                  NDC 23155-110-06

    Bottles of 100 tablets                                 NDC 23155-110-01

    Bottles of 500 tablets                                  NDC 23155-110-05

    Bottles of 1000 tablets                                 NDC 23155-110-10

    20mg: Each tablet is a blue colored, round, biconvex tablet, embossed with "P" and "20" on either side of the breakline on one side and plain on the other side.

    Each 20 mg tablet contains 20 mg of propranolol hydrochloride USP and is supplied in the following package sizes:

    Bottles of 30 tablets                                 NDC 23155-111-03

    Bottles of 60 tablets                                  NDC 23155-111-06

    Bottles of 100 tablets                                  NDC 23155-111-01

    Bottles of 500 tablets                                  NDC 23155-111-05

    Bottles of 1000 tablets                                 NDC 23155-111-10

    40mg: Each tablet is a green colored, round, biconvex tablet, embossed with "P" and "40"on either side of the breakline on one side and plain on the other side.

    Each 40 mg tablet contains 40 mg of propranolol hydrochloride USP and is supplied in the following package sizes:

    Bottles of 30 tablets                                 NDC 23155-112-03

    Bottles of 60 tablets                                  NDC 23155-112-06

    Bottles of 100 tablets                                 NDC 23155-112-01

    Bottles of 500 tablets                                  NDC 23155-112-05

    Bottles of 1000 tablets                                 NDC 23155-112-10

    60mg: Each tablet is a pink colored, round, biconvex tablet, embossed with "P" and "60" on either side of the breakline on one side and plain on the other side.

    Each 60 mg tablet contains 60 mg of propranolol hydrochloride USP and is supplied in the following package sizes:

    Bottles of 30 tablets                                 NDC 23155-113-03

    Bottles of 60 tablets                                  NDC 23155-113-06

    Bottles of 100 tablets                                 NDC 23155-113-01

    Bottles of 500 tablets                                  NDC 23155-113-05

    Bottles of 1000 tablets                                 NDC 23155-113-10

    80mg: Each tablet is a yellow colored, round, biconvex tablet, embossed with "P" and "80" on either side of the breakline on one side and plain on the other side.

    Each 80 mg tablet contains 80 mg of propranolol hydrochloride USP and is supplied in the following package sizes:

    Bottles of 30 tablets                                 NDC 23155-114-03

    Bottles of 60 tablets                                  NDC 23155-114-06

    Bottles of 100 tablets                                 NDC 23155-114-01

    Bottles of 500 tablets                                  NDC 23155-114-05

    Bottles of 1000 tablets                                 NDC 23155-114-10

    Storage: Store at 20°-25°C (68-(°77F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]

    Protect from light.

    Dispense in a well closed, light-resistant container as defined in USP.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Heritage Pharmaceuticals Inc.

    Edison, NJ 08837

    1.866.901.DRUG (3784)

    Manufactured by:

    Ipca Laboratories Limited

    48, Kandivli Ind. Estate,

    Mumbai 400 067, India.

    propranolol tabs-figure-02

    Iss. 0109

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  • PRINCIPAL DISPLAY PANEL


    NDC 68258-6010-XX

    NDC 68258-6010-XX

    NDC 68258-6010-03

    NDC 68258-6010-09

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  • INGREDIENTS AND APPEARANCE
    PROPRANOLOL HYDROCHLORIDE 
    propranolol hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68258-6010(NDC:23155-111)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL) PROPRANOLOL 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POVIDONE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STARCH, CORN  
    Product Characteristics
    Color blue Score 2 pieces
    Shape ROUND Size 7mm
    Flavor Imprint Code P;20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68258-6010-3 30 in 1 BOTTLE
    2 NDC:68258-6010-9 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078955 10/13/2008
    Labeler - Dispensing Solutions, Inc. (066070785)
    Registrant - PSS World Medical, Inc. (101822682)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 relabel, repack
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