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 SECTIONRx only - WARNING: MAY BE HABIT FORMING
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DESCRIPTIONThe 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 ...
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CLINICAL PHARMACOLOGYBarbiturates 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 ...
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INDICATIONS AND USAGESedative - Anticonvulsant – For the treatment of generalized and partial seizures.
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CONTRAINDICATIONSPhenobarbital 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 ...
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WARNINGSHabit 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 ...
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PRECAUTIONSGeneral - 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 ...
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ADVERSE REACTIONSThe following adverse reactions have been reported: CNS Depression – Residual sedation or "hangover", drowsiness, lethargy, and vertigo. Emotional disturbances and phobias may be accentuated. In ...
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DRUG ABUSE AND DEPENDENCEControlled Substance – Phenobarbital is a Schedule IV drug. Dependence – Barbiturates may be habit forming. Tolerance, psychological dependence, and physical dependence may occur, especially ...
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OVERDOSAGESigns 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 ...
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DOSAGE AND ADMINISTRATIONThe 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 ...
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HOW SUPPLIEDPhenobarbital 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 ...
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SPL UNCLASSIFIED SECTIONManufactured by: Genus Lifesciences Inc. Allentown, PA 18109 - Revised: October 2024
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PRINCIPAL DISPLAY PANEL - 15 mg Bottle LabelNDC 64950-571-01 - PHENOBARBITAL CIV - TABLETS, USP - 15 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
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PRINCIPAL DISPLAY PANEL - 16.2 mg Bottle LabelNDC 64950-572-01 - PHENOBARBITAL CIV - TABLETS, USP - 16.2 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
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PRINCIPAL DISPLAY PANEL - 30 mg Bottle LabelNDC 64950-573-01 - PHENOBARBITAL CIV - TABLETS, USP - 30 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
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PRINCIPAL DISPLAY PANEL - 32.4 mg Bottle LabelNDC 64950-574-01 - PHENOBARBITAL CIV - TABLETS, USP - 32.4 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
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PRINCIPAL DISPLAY PANEL - 60 mg Bottle LabelNDC 64950-575-01 - PHENOBARBITAL CIV - TABLETS, USP - 60 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
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PRINCIPAL DISPLAY PANEL - 64.8 mg Bottle LabelNDC 64950-576-01 - PHENOBARBITAL CIV - TABLETS, USP - 64.8 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
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PRINCIPAL DISPLAY PANEL - 97.2 mg Bottle LabelNDC 64950-577-01 - PHENOBARBITAL CIV - TABLETS, USP - 97.2 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
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PRINCIPAL DISPLAY PANEL - 100 mg Bottle LabelNDC 64950-578-01 - PHENOBARBITAL CIV - TABLETS, USP - 100 mg - WARNING: May be habit forming. Rx only - 100 Tablets - Genus - Lifesciences Inc.
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INGREDIENTS AND APPEARANCEProduct Information