Label: PHENOBARBITAL tablet

  • NDC Code(s): 64950-571-01, 64950-571-10, 64950-572-01, 64950-572-10, view more
  • Packager: Genus Lifesciences
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 3, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx only - WARNING: MAY BE HABIT FORMING
  • DESCRIPTION
    The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The ...
  • CLINICAL PHARMACOLOGY
    Barbiturates are capable of producing all levels of CNS mood alteration, from excitation to mild sedation, hypnosis, and deep coma. Overdosage can produce death. In high enough therapeutic doses ...
  • INDICATIONS AND USAGE
    Sedative - Anticonvulsant – For the treatment of generalized and partial seizures.
  • CONTRAINDICATIONS
    Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver ...
  • WARNINGS
    Habit Forming. Phenobarbital may be habit forming. Tolerance and psychological and physical dependence may occur with continued use (see DRUG ABUSE AND DEPENDENCE and Pharmacokinetics under ...
  • PRECAUTIONS
    General - Barbiturates may be habit forming. Tolerance and psychological and physical dependence may occur with continued use (see DRUG ABUSE AND DEPENDENCE). Barbiturates should be administered ...
  • ADVERSE REACTIONS
    The following adverse reactions have been reported: CNS Depression – Residual sedation or "hangover", drowsiness, lethargy, and vertigo. Emotional disturbances and phobias may be accentuated. In ...
  • DRUG ABUSE AND DEPENDENCE
    Controlled Substance – Phenobarbital is a Schedule IV drug. Dependence – Barbiturates may be habit forming. Tolerance, psychological dependence, and physical dependence may occur, especially ...
  • OVERDOSAGE
    Signs and Symptoms – The onset of symptoms following a toxic oral exposure to phenobarbital may not occur until several hours following ingestion. The toxic dose of barbiturates varies ...
  • DOSAGE AND ADMINISTRATION
    The dose of phenobarbital must be individualized with full knowledge of its particular characteristics. Factors of consideration are the patient's age, weight, and condition. Sedation - For ...
  • HOW SUPPLIED
    Phenobarbital Tablets, USP CIV are round, white bisected tablets and supplied as follows: Strength(mg)Tablet Markings DescriptionNDC# bottles of 100NDC# for bottles of 1000 - 15Round ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Genus Lifesciences Inc. Allentown, PA 18109 - Revised: October 2024
  • PRINCIPAL DISPLAY PANEL - 15 mg Bottle Label
    NDC 64950-571-01 - PHENOBARBITAL CIV - TABLETS, USP - 15 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
  • PRINCIPAL DISPLAY PANEL - 16.2 mg Bottle Label
    NDC 64950-572-01 - PHENOBARBITAL CIV - TABLETS, USP - 16.2 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
  • PRINCIPAL DISPLAY PANEL - 30 mg Bottle Label
    NDC 64950-573-01 - PHENOBARBITAL CIV - TABLETS, USP - 30 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
  • PRINCIPAL DISPLAY PANEL - 32.4 mg Bottle Label
    NDC 64950-574-01 - PHENOBARBITAL CIV - TABLETS, USP - 32.4 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
  • PRINCIPAL DISPLAY PANEL - 60 mg Bottle Label
    NDC 64950-575-01 - PHENOBARBITAL CIV - TABLETS, USP - 60 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
  • PRINCIPAL DISPLAY PANEL - 64.8 mg Bottle Label
    NDC 64950-576-01 - PHENOBARBITAL CIV - TABLETS, USP - 64.8 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
  • PRINCIPAL DISPLAY PANEL - 97.2 mg Bottle Label
    NDC 64950-577-01 - PHENOBARBITAL CIV - TABLETS, USP - 97.2 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
  • PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
    NDC 64950-578-01 - PHENOBARBITAL CIV - TABLETS, USP - 100 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
  • INGREDIENTS AND APPEARANCE
    Product Information