ETHOSUXIMIDE 250 mg/5mL Solution, 473 mL — NDC 0121-0670-16 (Billing 00121-0670-16)
This is a package of 473 mL of ETHOSUXIMIDE 250 mg/5mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since Nov 2000 and currently FDA-listed; retail pharmacies pay about $0.1005 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0121-0670-16 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0121 labeler · 0670 product · 16 package
- Package marketed since
- Nov 22, 2000
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 473 mL per package
- Barcode (UPC)
- 0301210670169
- Medicaid fills, this package
- 30,024 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004555
- GCN: 17430
- GPI-14 (Medi-Span): 72400010002005
- HICL (First Databank): 001891
- AHFS class code: 28:12.20.00
- RxCUI (RxNorm): 251322
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Anti-epileptic Agent class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Ethosuximide is used to control absence epilepsy — sometimes called petit mal epilepsy. These are brief seizures where you or your child may suddenly 'blank out' or stare for a few...
- You take ethosuximide by mouth — either as a capsule or a liquid solution. Your doctor will likely start you on a low dose and increase it slowly until your seizures are well contr...
- How should I take ethosuximide, and does it matter if I take it with food?
- The most common side effects are stomach-related — nausea, upset stomach, loss of appetite — and things like drowsiness, headache, or irritability. These often settle as your body...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ethosuximide — tap one for details:
Ethosuximide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.101 | $47.54 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1173 | $55.48 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1446 | $68.40 / 473 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00121-0670-16 You're viewing this Main listing | 473 mL in 1 BOTTLE | 2000-11-22 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ethosuximide 250 mg/5mL 59762-2350-06 | Mylan | 1 bottle | $0.081 | AA | FDA listed | save 19% |
| Ethosuximide 250 mg/5mLthis 00121-0670-16 | PAI | 473 ml | $0.100 | AA | Availability likely | — |
| Zarontin 250 mg/5mL 00071-2418-19 | Parke-Davis | 1 bottle | — | AA | FDA listed | — |
| Ethosuximide 250 mg/5mL 62135-0064-47 | Chartwell | 473 ml | — | AA | FDA listed | — |
| Ethosuximide 250 mg/5mL 68999-0064-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Ethosuximide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from PAI Holdings, LLC dba PAI Pharma labeler code 00121
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- Acetaminophen 160 mg/5mL Solution NDC 0121-0657-00
- Trihexyphenidyl Hydrochloride 2 mg/5mL Solution NDC 0121-0658-16
- VALPROIC ACID 250 mg/5mL Solution NDC 0121-0675-16
- Potassium Citrate and Citric Acid 1100 mg/5mL; 334 mg/5mL Solution NDC 0121-0676-16
- TRICITRATES POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE 550 mg/5mL; 500 mg/5mL; 334 mg/5mL Solution NDC 0121-0677-16
- Nortriptyline Hydrochloride 10 mg/5mL Solution NDC 0121-0678-16
- Fluoxetine 20 mg/5mL Solution NDC 0121-0721-04
- Ranitidine 15 mg/mL Syrup NDC 0121-0727-16
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ethosuximide is indicated for the control of absence (petit mal) epilepsy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Ethosuximide Oral Solution USP is administered by the oral route. The initial dose for patients 3 to 6 years of age is one teaspoonful (250 mg) per day; for patients 6 years of age and older, 2 teaspoonfuls (500 mg) per day. The dose thereafter must be individualized according to the patient's response.
Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician.
The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.
Ethosuximide may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.
⛔ Contraindications ▾
CONTRAINDICATION Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.
⚠️ Warnings ▾
WARNINGS Blood Dyscrasias: Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (e.g., sore throat, fever) develop, blood counts should be considered at that point. Drug-Induced Immune Thrombocytopenia: Drug-induced immune thrombocytopenia (DITP) has been reported with ethosuximide.
In the reported cases, the onset of symptoms occurred 1 to 3 weeks after initiation of ethosuximide; one patient had recurrence of symptoms within 1 day of a subsequent re-challenge with the drug. In those cases in which the platelet count was specified, the nadir was 2,000 and 3,000/mm 3 . When DITP is suspected, discontinue ethosuximide, monitor serial platelet counts, and treat as appropriate.
If possible, assess the presence of drug-dependent antiplatelet antibodies. Avoid future use of ethosuximide in patients with history of ethosuximide-induced DITP. Effects on Liver and Kidneys: Ethosuximide is capable of producing morphological and functional changes in the animal liver.
In humans, abnormal liver and renal function studies have been reported. Ethosuximide should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.
Systemic Lupus Erythematosus: Cases of systemic lupus erythematosus have been reported with the use of ethosuximide. The physician should be alert to this possibility. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including ethosuximide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.
There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.
Table 1 shows absolute and relative risk by indication for all evaluated AEDs. Table 1 Risk by indication for antiepileptic drugs in pooled analysis Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1.0 3.4 3.5
2.4Psychiatric 5.7 8.5 1.5
2.9Other 1.0 1.8 1.9
0.9T… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Body As A Whole: Allergic reaction, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Gastrointestinal System: Gastrointestinal symptoms occur frequently and include anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, and diarrhea. There have been reports of gum hypertrophy and swelling of the tongue.
Hemopoietic System: Hemopoietic complications associated with the administration of ethosuximide have included leukopenia, agranulocytosis, pancytopenia, with or without bone marrow suppression, eosinophilia and thrombocytopenia (see WARNINGS ). Nervous System: Neurologic and sensory reactions reported during therapy with ethosuximide have included drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, and ataxia. Psychiatric or psychological aberrations associated with ethosuximide administration have included disturbances of sleep, night terrors, inability to concentrate, and aggressiveness.
These effects may be noted particularly in patients who have previously exhibited psychological abnormalities. There have been rare reports of paranoid psychosis, increased libido, and increased state of depression with overt suicidal intentions. Integumentary System: Dermatologic manifestations which have occurred with the administration of ethosuximide have included urticaria, pruritic erythematous rashes, Stevens-Johnson syndrome, and hirsutism.
Special Senses: Myopia. Genitourinary System: Vaginal bleeding, microscopic hematuria. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions: Since ethosuximide may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (e.g., ethosuximide may elevate phenytoin serum levels and valproic acid has been reported to both increase and decrease ethosuximide levels).
🤰 Pregnancy ▾
Usage in Pregnancy: Ethosuximide crosses the placenta. Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.
Cases of birth defects have been reported with ethosuximide. The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodological problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects.
The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential. Ethosuximide is excreted in human breast milk. Because the effects of ethosuximide on the nursing infant are unknown, caution should be exercised when ethosuximide is administered to a nursing mother.
Ethosuximide should be used in nursing mothers only if the benefits clearly outweigh the risks.
Pregnancy: To provide information regarding the effects of in utero exposure to ethosuximide, physicians are advised to recommend that pregnant patients taking ethosuximide enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/ See WARNINGS.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established. (See DOSAGE AND ADMINISTRATION section.)
🆘 Overdosage ▾
OVERDOSAGE Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range of serum levels is 40 mcg/mL to 100 mcg/mL, although levels as high as 150 mcg/mL have been reported without signs of toxicity.
Treatment: Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics, and general supportive measures. Hemodialysis may be useful to treat ethosuximide overdose. Forced diuresis and exchange transfusions are ineffective.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ethosuximide Oral Solution USP is an orange-red colored oral solution. Each 5 mL contains 250 mg ethosuximide in a cherry-raspberry flavored base supplied in the following: NDC 0121-0670-16: 16 fl oz (473 mL) bottle STORAGE Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature] Preserve in tight containers. Protect from freezing and light.
📦 Storage and Handling ▾
STORAGE Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature] Preserve in tight containers. Protect from freezing and light.
📋 Description ▾
DESCRIPTION Ethosuximide is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula: Each teaspoonful (5 mL), for oral administration, contains 250 mg ethosuximide, USP. Also contains citric acid, FD&C Red No. 40, FD&C Yellow No.
6, cherry-raspberry flavoring, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose. Sodium hydroxide may be used for pH adjustment. The pH range is 5.0 to 6.5.
Chemical Structure
💬 Information for Patients ▾
Information for Patients: Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking ethosuximide. Instruct patients to take ethosuximide only as prescribed. Ethosuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.
Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen. Patients should be instructed to promptly contact their physician if they develop signs and/or symptoms (e.g., sore throat, fever), suggesting an infection. Patients, their caregivers, and families should be counseled that AEDs, including ethosuximide, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
Behaviors of concern should be reported immediately to healthcare providers. Prior to initiation of treatment with ethosuximide, the patient should be instructed that a rash may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.
This Registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy section).
💬 Medication Guide ▾
MEDICATION GUIDE Ethosuximide Oral Solution USP (eth" oh sux´ i mide) Read this Medication Guide before you start taking ethosuximide and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
If you have any questions about ethosuximide, ask your healthcare provider or pharmacist. What is the most important information I should know about ethosuximide? Do not stop taking ethosuximide without first talking to your healthcare provider.
Stopping ethosuximide suddenly can cause serious problems. Ethosuximide can cause serious side effects, including: Rare but serious blood problems that may be life-threatening. Call your healthcare provider right away if you have: fever, swollen glands, or sore throat that come and go or do not go away frequent infections or an infection that does not go away easy bruising red or purple spots on your body bleeding gums or nose bleeds severe fatigue or weakness Drug reactions that may affect different parts of the body such as your liver, kidneys, heart, or blood cells.
You may or may not have a rash with these types of reactions. These reactions can be very serious and can cause death. Call your healthcare provider right away if you have any of these symptoms: joint pain and swelling muscle pain fatigue, weakness low-grade fever pain in the chest that is worse with breathing skin rash swollen lymph glands swelling of your face yellowing of your skin or the white part of your eyes Like other antiepileptic drugs, ethosuximide may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop ethosuximide without first talking to a healthcare provider. Stopping ethosuximide suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. What is ethosuximide?
Ethosuximide is a prescription medicine used to treat absence (petit mal) seizures. Who should not take ethosuximide? Do not take ethosuximide if you are allergic to succinimides (methsuximide or ethosuximide), or any of the ingredients in ethosuximide oral solution.
See the end of this Medication Guide for a complete list of ingredients in ethosuximide oral solution. What should I tell my healthcare provider before taking ethosuximide? Before you take ethosuximide, tell your healthcare provider if you: have or had liver problems have or have had depression, mood problems or suicidal thoughts or behavior have any other medical conditions are pregnant or plan to become pregnant.
It is not known if ethosuximide can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking ethosuximide. You and your healthcare provider should decide if you should take ethosuximide while you are pregnant.
If you become pregnant while taking ethosuximide, talk to your healthcare provider ab… [Excerpted — this section continues on DailyMed.]
⚠️ Precautions ▾
PRECAUTIONS General: Ethosuximide, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients. As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status.
Information for Patients: Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking ethosuximide. Instruct patients to take ethosuximide only as prescribed. Ethosuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.
Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen. Patients should be instructed to promptly contact their physician if they develop signs and/or symptoms (e.g., sore throat, fever), suggesting an infection. Patients, their caregivers, and families should be counseled that AEDs, including ethosuximide, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
Behaviors of concern should be reported immediately to healthcare providers. Prior to initiation of treatment with ethosuximide, the patient should be instructed that a rash may herald a serious medical event and that the patient should report any such occurrence to a physician immediately. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.
This Registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy section). Drug Interactions: Since ethosuximide may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (e.g., ethosuximide may elevate phenytoin serum levels and valproic acid has been reported to both increase and decrease ethosuximide levels).
Pregnancy: To provide information regarding the effects of in utero exposure to ethosuximide, physicians are advised to recommend that pregnant patients taking ethosuximide enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/ See WARNINGS.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established. (See DOSAGE AND ADMINISTRATION section.)
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 473 mL Bottle NDC 0121-0670-16 Ethosuximide Oral Solution USP 250 mg/5 mL ALWAYS DISPENSE WITH ACCOMPANYING MEDICATION GUIDE Rx ONLY 16 fl oz (473 mL) PAI Pharma ethosuximide-container-label ethosuximide-container-label