Phenobarbital
Tablet · Oral
Uses
Sedative Anticonvulsant – For the treatment of generalized and partial seizures.
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 sedation, the drug may be administered in single dose of 30 to 120 mg repeated at intervals: frequency will be determined by the patient’s response. It is generally considered that no more than 400 mg of phenobarbital should be administered during a 24-hour period. Adults: Daytime Sedation: 30 to 120 mg daily in 2 to 3 divided doses. Oral Hypnotic: 100 to 200 mg. Anticonvulsant Use – Clinical laboratory reference values should be used to determine the therapeutic anticonvulsant level of phenobarbital in the serum. To achieve the blood levels considered therapeutic in pediatric patients, higher per-kilogram dosages are generally necessary for phenobarbital and most other anticonvulsants. In children and infants, phenobarbital at a loading dose of 15 to 20 mg/kg produces blood levels of about 20 mcg/mL shortly after administration. Phenobarbital has been used in the treatment and prophylaxis of febrile seizures. However, it has not been established that prevention of febrile seizures influences the subsequent development of epilepsy. Adults: 60 to 200 mg/day. Pediatric Patients: 3 to 6 mg/kg/day. Special Patient Population – Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease.
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 function or respiratory disease in which dyspnea or obstruction is evident.
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 CLINICAL PHARMACOLOGY ). Patients who have psychologic dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. In order to minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in a person who is dependent on the drug may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive doses over long periods of time (see DRUG ABUSE AND DEPENDENCE ). Acute or Chronic Pain. Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked. However, the use of barbiturates as sedatives in the postoperative surgical period and as adjuncts to cancer chemotherapy is well established. Usage in Pregnancy. Barbiturates can cause fetal damage when administered to a pregnant woman. Retrospective, case-controlled studies have suggested a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Barbiturates readily cross the placental barrier and are distributed throughout fetal tissues; the highest concentrations are found in the placenta, fetal liver, and brain. Fetal blood levels approach maternal blood levels following parenteral administration. Withdrawal symptoms occur in infants born to women who receive barbiturates throughout the last trimester of pregnancy (see DRUG ABUSE AND DEPENDENCE ). If phenobarbital is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Usage in Pediatric Patients. Phenobarbital has been reported to be associated with cognitive deficits in children taking it for complicated febrile seizures. Synergistic Effects. The concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects.
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 with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or have a history of drug abuse. Elderly or debilitated patients may react to barbiturates with marked excitement, depression, or confusion. In some persons, especially children, barbiturates repeatedly produce excitement rather than depression. In patients with hepatic damage, barbiturates should be administered with caution and initially in reduced doses. Barbiturates should not be administered to patients showing the premonitory signs of hepatic coma. The systemic effects of exogenous and endogenous corticosteroids may be diminished by phenobarbital. Thus, this product should be administered with caution to patients with borderline hypoadrenal function, regardless of whether it is of pituitary or of primary adrenal origin. Information for Patients The following information and instructions should be given to patients receiving barbiturates. The use of barbiturates carries with it an associated risk of psychological and/or physical dependence. The patient should be warned against increasing the dose of the drug without consulting a physician. Barbiturates may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly. Alcohol should not be consumed while taking barbiturates. The concurrent use of the barbiturates with other CNS depressants (e.g., alcohol, narcotics, tranquilizers, and antihistamines) may result in additional CNS-depressant effects. Laboratory Tests Prolonged therapy with barbiturates should be accompanied by periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic systems (see General under PRECAUTIONS and ADVERSE REACTIONS ). Drug Interactions Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies. Anticoagulants. Phenobarbital lowers the plasma levels of dicumarol and causes a decrease in anticoagulant activity as measured by the prothrombin time. Barbiturates can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (e.g., acenocoumarol, warfarin, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen. Corticosteroids. Barbiturates appear to enhance the metabolism of exogenous corticosteroids, probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen. Griseofulvin. Phenobarbital appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. The effect of the resultant decreased blood levels of griseofulvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs. Doxycycline. Phenobarbital has been shown to shorten the half-life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued. This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic. If phenobarbital and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely. Phenytoin, Sodium Valproate, Valproic Acid. The effect of barbiturates on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, whereas others report no effect. Because the effect of barbiturates on the metabolism of phenytoin is not predictable, phenytoin and barbiturate blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid increase the phenobarbital serum levels; therefore, phenobarbital blood levels should be closely monitored and appropriate dosage adjustments made as clinically indicated. CNS Depressants. The concomitant use of other CNS depressants, including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects. Monoamine Oxidase Inhibitors (MAOIs). MAOIs prolong the effects of barbiturates, probably because metabolism of the barbiturate is inhibited. Estradiol, Estrone, Progesterone, and other Steroidal Hormones. Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (e.g., phenobarbital) who become pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking phenobarbital. Carcinogenesis Animal Data. Phenobarbital sodium is carcinogenic in mice and rats after lifetime administration. In mice, it produced benign and malignant liver cell tumors. In rats, benign liver cell tumors were observed very late in life. Human Data. In a 29-year epidemiological study of 9,136 patients who were treated on an anticonvulsant protocol that included phenobarbital, results indicated a higher than normal incidence of hepatic carcinoma. Previously, some of these patients had been treated with thorotrast, a drug which is known to produce hepatic carcinomas. Thus, this study did not provide sufficient evidence that phenobarbital sodium is carcinogenic in humans.
Side effects
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 some persons, barbiturates such as phenobarbital repeatedly produce excitement rather than depression, and the patient may appear to be inebriated. Irritability and hyperactivity can occur in children. Like other nonanalgesic hypnotic drugs, barbiturates such as phenobarbital, when given in the presence of pain, may cause restlessness, excitement, and even delirium. Rarely, the use of barbiturates results in localized or diffuse myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia. The pain may appear in paroxysms, is most intense in the early morning hours, and is most frequently located in the region of the neck, shoulder girdle, and upper limbs. Symptoms may last for days after the drug is discontinued. Respiratory/Circulatory – Respiratory depression, apnea, circulatory collapse. Allergic – Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital. Other – Nausea and vomiting; headache, osteomalacia. The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients who received barbiturates. Because such patients may be less aware of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients. More than 1 in 100 Patients: The most common adverse reaction, estimated to occur at a rate of 1 to 3 patients per 100, is: Nervous System: Somnolence Less than 1 in 100 Patients: Adverse reactions estimated to occur at a rate of less than 1 in 100 patients are listed below, grouped by organ system and by decreasing order of occurrence: Nervous System: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormality in thinking Respiratory System: Hypoventilation, apnea Cardiovascular System: Bradycardia, hypotension, syncope Digestive System: Nausea, vomiting, constipation Other Reported Reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use
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 considerably. In general, an oral dose of 1 g of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 g of ingested barbiturate. The sedated, therapeutic blood levels of phenobarbital range between 5 to 40 mcg/mL; the usual lethal blood level ranges from 100 to 200 mcg/mL. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and various neurologic disorders. Potential tolerance must be considered when evaluating significance of dose and plasma concentration. The manifestations of a long-acting barbiturate in overdose include nystagmus, ataxia, CNS depression, respiratory depression, hypothermia, and hypotension. Other findings may include absent or depressed reflexes and erythematous or hemorrhagic blisters (primarily at pressure points). Following massive exposure to phenobarbital, pulmonary edema, circulatory collapse with loss of peripheral vascular tone, cardiac arrest, and death may occur. In extreme overdose, all electrical activity in the brain may cease, in which case a “flat” EEG normally equated with clinical death should not be accepted. This effect is fully reversible unless hypoxic damage occurs. Consideration should be given to the possibility of barbiturate intoxication even in situations that appear to involve trauma. Complications such as pneumonia, pulmonary edema, cardiac arrhythmias, congestive heart failure, and renal failure may occur. Uremia may increase CNS sensitivity to barbiturates if renal function is impaired. Differential diagnosis should include hypoglycemia, head trauma, cerebrovascular accidents, convulsive states, and diabetic coma. Treatment – To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR) . In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Protect the patient’s airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient’s airway when employing gastric emptying or charcoal. Alkalinization of urine hastens phenobarbital excretion, but dialysis and hemoperfusion are more effective and cause less troublesome alterations in electrolyte equilibrium. If the patient has chronically abused sedatives, withdrawal reactions may be manifest following acute overdose.
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 barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula: Each phenobarbital tablet, USP contains 15 mg, 16.2 mg (¼ grain), 30 mg, 32.4 mg (½ grain), 60 mg, 64.8 mg (1 grain) 97.2 mg (1½ grain), or 100 mg of phenobarbital, USP. In addition, each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. "Image Description"
How supplied
Phenobarbital tablets, USP, 15 mg are white round tablets, debossed on one side with “CE” above “275” and plain on other side. Supplied in bottles of 90: Bottles of 90 NDC 62135-510-90 Phenobarbital tablets, USP, 16.2 mg (¼ grain) are white round, scored tablets, debossed with “CE” above the score and “279” below on one side and plain on other side. Supplied in bottles of 90: Bottles of 90 NDC 62135-539-90 Phenobarbital tablets, USP, 30 mg are white round, scored tablets, debossed with “CE” above the score and “276” below on one side and plain on other side. Supplied in bottles of 90: Bottles of 90 NDC 62135-514-90 Phenobarbital tablets, USP, 32.4 mg (½ grain) are white round, scored tablets, debossed with “CE” above the score and “280” below on one side and plain on other side. Supplied in bottles of 90: Bottles of 90 NDC 62135-554-90 Phenobarbital tablets, USP, 60 mg white round, scored tablets, debossed with “CE” above the score and “277” below on one side and plain on other side. Supplied in bottles of 90: Bottles of 90 NDC 62135-515-90 Phenobarbital tablets, USP, 64.8 mg (1 grain) are white round, scored tablets, debossed with “CE” above the score and “281” below on one side and plain on other side. Supplied in bottles of 90: Bottles of 90 NDC 62135-557-90 Phenobarbital tablets, USP, 97.2 mg (1 ½ grain) are white round, scored tablets, debossed with “CE” above the score and “282” below on one side and plain on other side. Supplied in bottles of 90: Bottles of 90 NDC 62135-558-90 Phenobarbital tablets, USP, 100 mg are white round, scored tablets, debossed with “CE” above the score and “278” below on one side and plain on other side. Supplied in bottles of 90: Bottles of 90 NDC 62135-519-90 Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Rev. 08/2026 L73032
Label text from the FDA structured product label by Chartwell RX, LLC (revised Aug 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Phenobarbital in 158 products
Phenobarbital NDC products (158)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 60687-671 | Phenobarbital 20 mg/5mL Elixir | American Health Packaging | UNAPPROVED DRUG OTHER · DEA CIV |
| 72162-1268 | Phenobarbital 20 mg/5mL Liquid | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 63629-2289 | Phenobarbital 16.2 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 63629-2399 | Phenobarbital 20 mg/5mL Liquid | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 63629-2400 | Phenobarbital 16.2 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 63629-2401 | Phenobarbital 16.2 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 63629-2402 | Phenobarbital 64.8 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 63629-2403 | Phenobarbital 64.8 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 63629-2404 | Phenobarbital 97.2 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 72162-1265 | Phenobarbital 64.8 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 72162-1168 | Phenobarbital 97.2 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 72162-1167 | Phenobarbital 64.8 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 72162-1166 | Phenobarbital 16.2 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 72162-1266 | Phenobarbital 97.2 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 72162-1267 | Phenobarbital 16.2 mg/1 Tablet | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER · DEA CIV |
| 68999-962 | Phenobarbital 20 mg/5mL Solution | Chartwell Governmental & Specialty RX, LLC. | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-539 | Phenobarbital 16.2 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-962 | Phenobarbital 20 mg/5mL Solution | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-558 | Phenobarbital 97.2 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-557 | Phenobarbital 64.8 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-554 | Phenobarbital 32.4 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-510 | Phenobarbital 15 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-519 | Phenobarbital 100 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-515 | Phenobarbital 60 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-514 | Phenobarbital 30 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-405 | Phenobarbital 16.2 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-406 | Phenobarbital 32.4 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-407 | Phenobarbital 64.8 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-408 | Phenobarbital 97.2 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-409 | Phenobarbital 15 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-410 | Phenobarbital 30 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-411 | Phenobarbital 60 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 62135-412 | Phenobarbital 100 mg/1 Tablet | Chartwell RX, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 58118-1626 | Phenobarbital 32.4 mg/1 Tablet | Clinical Solutions Wholesale, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 58118-0626 | Phenobarbital 32.4 mg/1 Tablet | Clinical Solutions Wholesale, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 58118-0576 | Phenobarbital 64.8 mg/1 Tablet | Clinical Solutions Wholesale, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 58118-0574 | Phenobarbital 32.4 mg/1 Tablet | Clinical Solutions Wholesale, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 58118-0573 | Phenobarbital 30 mg/1 Tablet | Clinical Solutions Wholesale, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 58118-0572 | Phenobarbital 15 mg/1 Tablet | Clinical Solutions Wholesale, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 67046-1543 | Phenobarbital 97.2 mg/1 Tablet | Coupler LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 67046-1434 | Phenobarbital 64.8 mg/1 Tablet | Coupler LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 67046-0780 | Phenobarbital 64.8 mg/1 Tablet | Coupler LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 67046-0059 | Phenobarbital 32.4 mg/1 Tablet | Coupler LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13517-625 | Phenobarbital 16.2 mg/1 Tablet | e5 Pharma, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13517-626 | Phenobarbital 32.4 mg/1 Tablet | e5 Pharma, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13517-627 | Phenobarbital 64.8 mg/1 Tablet | e5 Pharma, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13517-628 | Phenobarbital 97.2 mg/1 Tablet | e5 Pharma, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13517-692 | Phenobarbital 30 mg/1 Tablet | e5 Pharma, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13517-693 | Phenobarbital 60 mg/1 Tablet | e5 Pharma, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13517-694 | Phenobarbital 100 mg/1 Tablet | e5 Pharma, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 51293-694 | Phenobarbital 100 mg/1 Tablet | ECI Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 64950-572 | Phenobarbital 16.2 mg/1 Tablet | Genus Lifesciences | UNAPPROVED DRUG OTHER · DEA CIV |
| 64950-571 | Phenobarbital 15 mg/1 Tablet | Genus Lifesciences | UNAPPROVED DRUG OTHER · DEA CIV |
| 64950-573 | Phenobarbital 30 mg/1 Tablet | Genus Lifesciences | UNAPPROVED DRUG OTHER · DEA CIV |
| 64950-574 | Phenobarbital 32.4 mg/1 Tablet | Genus Lifesciences | UNAPPROVED DRUG OTHER · DEA CIV |
| 64950-575 | Phenobarbital 60 mg/1 Tablet | Genus Lifesciences | UNAPPROVED DRUG OTHER · DEA CIV |
| 64950-576 | Phenobarbital 64.8 mg/1 Tablet | Genus Lifesciences | UNAPPROVED DRUG OTHER · DEA CIV |
| 64950-577 | Phenobarbital 97.2 mg/1 Tablet | Genus Lifesciences | UNAPPROVED DRUG OTHER · DEA CIV |
| 64950-578 | Phenobarbital 100 mg/1 Tablet | Genus Lifesciences | UNAPPROVED DRUG OTHER · DEA CIV |
| 0143-1455 | Phenobarbital 60 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 0143-1500 | Phenobarbital 30 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 0143-1495 | Phenobarbital 15 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 0143-1458 | Phenobarbital 100 mg/1 Tablet | Hikma Pharmaceuticals USA Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 0904-6575 | Phenobarbital 32.4 mg/1 Tablet | Major Pharmaceuticals | UNAPPROVED DRUG OTHER · DEA CIV |
| 0603-5168 | Phenobarbital 97.2 mg/1 Tablet | Par Health USA, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 0603-5167 | Phenobarbital 64.8 mg/1 Tablet | Par Health USA, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 0603-5166 | Phenobarbital 32.4 mg/1 Tablet | Par Health USA, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 0603-5165 | Phenobarbital 16.2 mg/1 Tablet | Par Health USA, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 0121-0531 | Phenobarbital 20 mg/5mL Solution | Pharmaceutical Associates, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-851 | Phenobarbital 100 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-890 | Phenobarbital 30 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-889 | Phenobarbital 16.2 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 82804-999 | Phenobarbital 100 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-850 | Phenobarbital 97.2 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-849 | Phenobarbital 64.8 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-848 | Phenobarbital 60 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-847 | Phenobarbital 32.4 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-846 | Phenobarbital 16.2 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-845 | Phenobarbital 15 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-892 | Phenobarbital 64.8 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-893 | Phenobarbital 97.2 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 82804-982 | Phenobarbital 16.2 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 63187-895 | Phenobarbital 32.4 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 82804-983 | Phenobarbital 32.4 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 82804-984 | Phenobarbital 64.8 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 82804-985 | Phenobarbital 97.2 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 82804-996 | Phenobarbital 15 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 82804-997 | Phenobarbital 30 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 82804-998 | Phenobarbital 60 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 71205-891 | Phenobarbital 32.4 mg/1 Tablet | Proficient Rx LP | UNAPPROVED DRUG OTHER · DEA CIV |
| 70752-168 | Phenobarbital 100 mg/1 Tablet | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 70752-161 | Phenobarbital 16.2 mg/1 Tablet | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 70752-162 | Phenobarbital 32.4 mg/1 Tablet | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 70752-163 | Phenobarbital 64.8 mg/1 Tablet | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 70752-164 | Phenobarbital 97.2 mg/1 Tablet | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 70752-165 | Phenobarbital 15 mg/1 Tablet | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 70752-166 | Phenobarbital 30 mg/1 Tablet | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 70752-167 | Phenobarbital 60 mg/1 Tablet | QUAGEN PHARMACEUTICALS LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 67296-2145 | Phenobarbital 32.4 mg/1 Tablet | Redpharm Drug | UNAPPROVED DRUG OTHER · DEA CIV |
| 70518-4129 | Phenobarbital 32.4 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER · DEA CIV |
| 70518-4720 | Phenobarbital 97.2 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER · DEA CIV |
| 70518-4719 | Phenobarbital 16.2 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER · DEA CIV |
| 70518-4718 | Phenobarbital 32.4 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER · DEA CIV |
| 70518-4717 | Phenobarbital 64.8 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER · DEA CIV |
| 70518-4215 | Phenobarbital 64.8 mg/1 Tablet | REMEDYREPACK INC. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-667 | Phenobarbital 64.8 mg/1 Tablet | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-668 | Phenobarbital 97.2 mg/1 Tablet | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-669 | Phenobarbital 100 mg/1 Tablet | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-670 | Phenobarbital 15 mg/1 Tablet | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-671 | Phenobarbital 16.2 mg/1 Tablet | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-672 | Phenobarbital 30 mg/1 Tablet | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-673 | Phenobarbital 32.4 mg/1 Tablet | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-675 | Phenobarbital 20 mg/5mL Liquid | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 16571-674 | Phenobarbital 60 mg/1 Tablet | Rising Pharma Holdings, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 64380-166 | Phenobarbital 20 mg/5mL Elixir | Strides Pharma Science Limited | UNAPPROVED DRUG OTHER · DEA CIV |
| 51672-5333 | Phenobarbital 60 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 51672-5326 | Phenobarbital 16.2 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 51672-5327 | Phenobarbital 32.4 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 51672-5328 | Phenobarbital 64.8 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 51672-5329 | Phenobarbital 97.2 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 51672-5334 | Phenobarbital 100 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 51672-5331 | Phenobarbital 15 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 51672-5332 | Phenobarbital 30 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-306 | Phenobarbital 64.8 mg/1 Tablet | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-307 | Phenobarbital 97.2 mg/1 Tablet | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-305 | Phenobarbital 32.4 mg/1 Tablet | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-304 | Phenobarbital 16.2 mg/1 Tablet | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-303 | Phenobarbital 100 mg/1 Tablet | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-301 | Phenobarbital 30 mg/1 Tablet | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-300 | Phenobarbital 15 mg/1 Tablet | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-302 | Phenobarbital 60 mg/1 Tablet | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 13811-299 | Phenobarbital 20 mg/5mL Elixir | Trigen Laboratories, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-692 | Phenobarbital 30 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-693 | Phenobarbital 60 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-694 | Phenobarbital 100 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-628 | Phenobarbital 97.2 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-627 | Phenobarbital 64.8 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-626 | Phenobarbital 32.4 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-625 | Phenobarbital 16.2 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-445 | Phenobarbital 100 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-444 | Phenobarbital 97.2 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-691 | Phenobarbital 15 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-357 | Phenobarbital 20 mg/5mL Liquid | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-367 | Phenobarbital 20 mg/5mL Elixir | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-438 | Phenobarbital 15 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-439 | Phenobarbital 16.2 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-440 | Phenobarbital 30 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-441 | Phenobarbital 32.4 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-443 | Phenobarbital 64.8 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 69367-442 | Phenobarbital 60 mg/1 Tablet | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 75826-143 | Phenobarbital 100 mg/1 Tablet | WINDER LABORATORIES, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 75826-142 | Phenobarbital 97.2 mg/1 Tablet | WINDER LABORATORIES, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 75826-141 | Phenobarbital 64.8 mg/1 Tablet | WINDER LABORATORIES, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 75826-140 | Phenobarbital 60 mg/1 Tablet | WINDER LABORATORIES, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 75826-139 | Phenobarbital 32.4 mg/1 Tablet | WINDER LABORATORIES, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 75826-138 | Phenobarbital 30 mg/1 Tablet | WINDER LABORATORIES, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 75826-137 | Phenobarbital 16.2 mg/1 Tablet | WINDER LABORATORIES, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
| 75826-136 | Phenobarbital 15 mg/1 Tablet | WINDER LABORATORIES, LLC | UNAPPROVED DRUG OTHER · DEA CIV |
Phenobarbital recalls
- D-1045-2017 Nov 30, 2016 · Class II · Terminated
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Frequently asked questions
What is Phenobarbital used for?
Sedative Anticonvulsant – For the treatment of generalized and partial seizures.
What are the side effects of Phenobarbital?
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 some persons, barbiturates such as phenobarbital repeatedly produce excitement rather than depression, and the patient may appear to be inebriated. Irritability and hyperactivity can occur in children.… See the full label for the complete list.
Who makes Phenobarbital?
Phenobarbital is listed by 23 labelers in the FDA NDC directory, including American Health Packaging, Bryant Ranch Prepack, Chartwell Governmental & Specialty RX, LLC., Chartwell RX, LLC.
Has Phenobarbital been recalled?
The FDA enforcement database lists 1 recall for Phenobarbital, most recently D-1045-2017 (class ii): Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point