is benzonatate dangerousis benzonatate dangerous

It does not smell nor look bad and it has been in a dark cabinet. Drug Overdose deaths in the United States hit record numbers in 2014. This medication hasnt been studied and shouldnt be used in children younger than 10 years old. Benzonatate may also be called an anti-tussive. View complete list of side effects. Can celebrex expire/go bad? Comments: This drug should be swallowed whole. All rights reserved. Warnings (2015, December). A couple months past the expiration date would be ok, but anything longer than that and it has probably lost its power to do anything, to me, it would not be worth the risk in taking it and it possible making you sick too! Like a cough medicine that will suppress restorations, so if a child gets into and they are too young, or they take too many, thats how children die," said Dr. Baggerman. Benzonatate information for Healthcare Professionals. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Some of these side effects may result from chewing or sucking on a capsule. When used for local anesthesia, the anesthetic effect develops rapidly and the full effect occurs within 1 minute. Use a cool mist humidifier or a vaporizer to increase air moisture in your home. Numbs the throat to make the cough less active. Last updated on Oct 31, 2022. Even more challenging is the rapid metabolism of the series of n-ethoxy parent compounds without a suitable pure standard available for quantitation of each specific molecular weight. Still looking for answers? Not recommended during pregnancy; only use if benefits outweigh risks. You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). If you take too much: You could have dangerous levels of the drug in your body. You should not use this medicine if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). How Does Respiratory Syncytial Virus (RSV) Spread? There are no known significant interactions with benzonatate. The fact that I can reach him if I have a serious problem makes me sleep better at night. Date is it safe to take? This can be harmful or prevent the drug from working well. 2. (, Bhole, M.V., Manson, A.L., Seneviratne, S.L., Misbah, S.A. (, Cohen, V., Jellinek, S.P., Stansfield, L., Truong, H., Baseluos, C., Marshall, J.P. (, Cohan, J.A., Manning, T.J., Lukash, L., Long, C., Ziminski, K.R., Conradi, S.E. Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. It is not to be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm with the cough. Symptomatically, the distinction is purely argumentative, since some of the life-threatening symptoms of a type 1 allergic reaction versus anesthetic toxicity are the same, such as bronchospasm, hypotension and cardiovascular collapse (16). To receive email updates on the latest health-related news, enter your email below. How should this medicine be used? Dont store this medication in moist or damp areas, such as bathrooms. Fast-acting. Deaths have been reported within hours of the accidental ingestion. The drug is not approved for children younger than 10 years old. (2017, March 22), Tessalon 100 mg perles, 200 mg capsules (benzonatate, USP). information and will only use or disclose that information as set forth in our notice of However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. The Medical Letter authors conclude when a cough suppressant is truly necessary, dextromethorphan or even codeine might be a safer choice. When codeine compares favorably in safety to another medicine, it might be time to reconsider why we ever use it. STORAGE: Store at room temperature away from light and moisture. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Do not exceed a single dose of 200mg or a total daily dose of 600mg. Benzonatate is rapidly hydrolyzed by plasma butyrylcholinesterase (BChE) to the major metabolite 4-(butylamino)benzoic acid (BABA) along with the corresponding polyethylene glycol monomethyl ethers (Figure, Inhibition of cough-reflex sensitivity by benzonatate and guaifenesin in acute viral cough, Clinical perspective-cough: an unmet need, Analysis of benzonatate overdoses among adults and children from 19692010 by the United States Food and Drug Administration, Benzonatate inhibition of voltage-gated sodium currents, Disposition of Toxic Drugs and Chemicals in Man, Benzonatate overdose associated with seizures and arrhythmias, The Medical Letter on Drugs and Therapeutics, Benzonatate toxicity in a teenager resulting in coma, seizures and severe metabolic acidosis, The Journal of Pediatric Pharmacology and Therapeutics, Local anesthetics: review of pharmacological considerations, Understanding allergic reactions to local anesthetics, Allergic reactions to local anesthetic formulations, IgE-mediated allergy to local anaesthetics: separating fact from perception: a UK perspective, Cardiac arrest with residual blindness after overdose of Tessalon, Degradation kinetics of benzonatate in aqueous solutions, Two fatalities resulting from Tessalon (benzonatate), Intravenous lipid emulsion for local anesthetic toxicity, A 17-year-old girl with cough-pulseless after drug overdose, Lipid emulsion for local anetstetic systemic toxicity, Loperamide-related deaths in North Carolina, Benzonatate ingestion reported to the National Poison Center Database System (NPDS), Journal of Medical Toxicology: Official Journal of the American College of Medical Toxicology, The Author 2017. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Nortriptyline belongs to a class of drugs called tricyclic. the unsubscribe link in the e-mail. Available for Android and iOS devices. Catalog No. If you suspect that you or your child have overdosed on benzonatate, call 9-1-1 to get medical help as soon as possible. If we combine this information with your protected This can help make sure you stay safe while you take this drug. (Links to The Medical Letter review and the FDA warning are below.). How to tell if the drug is working: You shouldnt cough as much. Blood data is inconclusive or unavailable in the majority of death cases (6, 10), however fatalities have been reported with blood concentrations of 5 and 35 mg/L (9, 22). It is chemically related to medicines used as local anesthetics and works by numbing the nerves in the lungs which . Some of these side effects may result from chewing or. Disclaimer: Our goal is to provide you with the most relevant and current information. Overdose of benzonatate has been reported in adults and adolescents. Take benzonatate exactly as prescribed by your doctor. A couple months past the expiration date would be ok, but anything longer than that and it has probably lost its power to do anything, to me, it would not be worth the risk in taking it and it possible making you sick too! Dont worry about airport X-ray machines. The safety and effectiveness of benzonatate in children below the age of 10 years have not been established. Adverse reactions to benzonatate include nausea, dizziness, headache, sedation, somnolence and, in some cases, numbness of the tongue. Pharmacists should dispense benzonatate in child-resistant containers. Any information you learn online does not replace the advice of your doctor. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. Overdose with benzonatate in children less than 2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. (, Yoshioka, I., Surmaitis, R., Katz, K.D. Medically reviewed by Philip Thornton, DipPharm. Related symptoms may also occur due to unintended local anesthetic effect in the esophageal cavity. pug? Skip the missed dose and use your next dose at the regular time. Death can occur from the misuse of cough and cold medicines in very young children. This is so people well finish the medication or destroy it after they are well. http://www.fda.gov/drugs/drugsafety/ucm236651.htm (accessed Aug 12, 2016). Other drugs that have the same active ingredients (e.g. How dangerous would it be for either a 5 lb. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. hallucinations (seeing or hearing something that isnt there). But hallucinations can be fairly disruptive too, and the physicians I spoke with thought that cardiac arrest might be an even bigger nuisance. RI. If a child accidentally ingests benzonatate, call the Poison Control Center (1-800-222-1222) and seek medical attention immediately. Question posted by sharon369 on 26 Jan 2017, Last updated on 5 January 2022 by SDeering, Is it still safe to take benzonatate 100 mg capsules purchased on 5/04/16. This content does not have an English version. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. All rights reserved. Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Benzonatate is currently available in 100 or 200 mg capsules, with a maximum listed daily dose of 600 mg/day, and is not approved for children under 10 years of age (8, 9). Talk to your doctor if you breastfeed your child. information is beneficial, we may combine your email and website usage information with Adults and children 10 and older can take 100 milligrams of benzonatate up to three times a day, according to Mayo Clinic . Copyright 2023 IBM Watson Health. Dosage of drugs is not considered in the study. Benzonatate [Package Insert]. Last medically reviewed on November 9, 2015. Benzonatate relieves a dry cough; however, the capsules must be swallowed whole because the risk of a fatal overdosage is increased if the capsules are opened in any way. All rights reserved. You may need to show airport staff the pharmacy label for your medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. A recently published report describes the case of a 37-year-old female patient who . Nintedanib is a tyrosine kinase inhibitor taken twice daily. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash. FDA encourages healthcare professionals to talk with their patients about this risk. Can be taken up to three times daily. Sucking or chewing the capsule may cause serious side effects. Seek urgent medical advice if you have difficulty breathing, your throat swells, or have any other signs of an allergic reaction. Image reprinted with permission from Medscape.com, 2010. Benzonatate: A Cough Suppressant So Dangerous, You'd Rather Just Cough. Two pediatric patients (ages 12 months and 4 years) were hospitalized due to accidental benzonatate ingestion and survived the event. This information is not a substitute for medical advice. Expiration date on a bottle of Naproxen is: Feb 6, 2012. (. Medicines that interact with benzonatate may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with benzonatate. Winter, M.L., Spiller, H.A., Griffith, J.R. (, Oxford University Press is a department of the University of Oxford. Respiratory Syncytial Virus (RSV) Infection, Respiratory Syncytial Virus (RSV) Vaccine, What to Know About RSVs Seasonal Trends and Symptoms, What to know about Respiratory Syncytial Virus (RSV) Tests, The 8 Best Air Purifiers for Dust of 2023, Debra Sullivan, Ph.D., MSN, R.N., CNE, COI, Symptoms of a Collapsed Trachea and What They Mean. It is taken three times a day with food. Women who are breastfeeding: Benzonatate may pass into breast milk and may cause side effects in a child who is breastfed. Always carry the original prescription-labeled box with you. If children accidentally take benzonatate seek medical attention immediately. privacy practices. Benzonatate is used to relieve coughing. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it. Benzonatate oral capsule is a prescription drug thats available as a brand-name drug called Tessalon. Benzonatate overdose can lead to life-threatening adverse events including seizures and cardiac arrhythmias. This material may not be published, broadcast, rewritten, or redistributed. If the patient chews or sucks the liquid-filled capsules or "softgels", the drug can cause laryngospasm, bronchospasm and circulatory collapse. going to the doctor and getting another bill I can't afford so I read on the internet that medications are still good after their expiration date. Ask your chi How to store benzonatate? There havent been enough studies done in humans to be certain how the drug might affect the fetus. This may make it easier for you to breathe and help decrease your cough. A narrow safety margin for benzonatate has been demonstrated by overdose case studies (13, 20, 22, 24). If you are a Mayo Clinic patient, this could Generally speaking, the contagiousness of RSV is slightly higher or comparable to other respiratory viruses. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use benzonatate only for the indication prescribed. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Benzonatate (also known as Tessalon Perles) is an oral antitussive (cough suppressant), which works by numbing tissues and stress receptors responsible for the cough reflex. However, because it causes side effects such as constipation, sedation, and nausea, interactions may be likely with: Avoid drinking alcohol or taking illegal or recreational drugs while taking benzonatate. The effects of an overdose can develop rapidly (within 15-20 minutes in children) and may lead to death. This medication is sometimes used in dogs for chronic cough. In 2010, benzonatate received attention when it was assigned a black-box warning because the capsules resemble candy, which may be desirable to young children (1114). information highlighted below and resubmit the form. Benzonatate may cause various side . The maximum dosage is 600 mg per day. Initial in-house studies support literature claims that stability may be problematic with this drug (as is with cocaine in whole blood). Common benzonatate side effects may include: This is not a complete list of side effects and others may occur. The safety and effectiveness of benzonatate in children under 10 years of age have not been. Disclaimer: Our goal is to provide you with the most relevant and current information. The biggest increase was 24% from 2015 to 2016. Im certainly sympathetic to the miserable patient with a cold or bronchitis who has a terrible cough. An overdose can be fatal, especially to a young child who has accidentally swallowed the medicine. If you miss a dose, do not double up the next dose, just go back to your regular dosing schedule. Benzonatate is used to relieve coughs due to colds or influenza (flu). Taken in overdose, benzonatate can rapidly cause seizures, cardiac arrhythmias and death. Details obtained through investigation by the medical examiner helped to support the possibility of benzonatate over-ingestion in some of our in-house cases. Can ChatGPT write a Jewish Journal column. Your doctor will write the number of refills authorized on your prescription. The old adage, when in doubt, throw it out, really applies here! Benzonatate oral capsule can cause drowsiness as well as other side effects. Copyright 2022 Scripps Media, Inc. All rights reserved. It may also act on the cough center in the brain. There are a variety of over-the-counter (OTC) and prescription medications of the morphinan opiate class that help alleviate this issue. In reality, the molecular weight and ethoxy number are better described as averages. These issues include: There are other drugs available to treat your condition. Mayo Clinic does not endorse companies or products. Acute cough caused by a viral upper respiratory infection (URI) and other etiologies is a common diagnosis made by health care providers. Do not give this medication to a child younger than 10 years old without medical advice. The safety and effectiveness of benzonatate in children under 10 years of age have not been established. Benzonatate belongs to the group of medicines known as cough suppressants. For pregnant women: Benzonatate is a category C pregnancy drug. Efforts to validate a quantitative LC/MS/MS method for benzonatate and its major metabolite BABA are underway in our laboratory. Sedation, headache, constipation, nausea, itchiness, skin rash, nasal congestion, a burning sensation in the eyes. Benzonatate is a cough suppressant available by prescription as a generic medication or under the brand Tessalon. The quantities ingested ranged from 1 or 2 to 30 benzonatate capsules. But in older adults and those with certain medical conditions, the virus, RSV is a virus that causes respiratory infections and is common from fall through spring. Benzonatate may also be called an anti-tussive. Portions of this document last updated: Feb. 01, 2023. Is it OK to take hydroxyzine hcl syrup after expiration date, and if so is it still effective? Last updated on May 26, 2022. Is it okay to take propranolol past the expiration date on the bottle. Major Pharmaceuticals. Take each dose with a full glass of water. Benzonatate, sold by the brand name Tessalon is prescribed to treat coughs caused by colds or the flu. Call 911 if your symptoms feel life-threatening or if you think youre having a medical emergency. Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. Benzonatate is thought to work by reducing coughing by anesthetizing certain receptors located in the breathing passages and lungs, dampening down their activity, and reducing the cough reflex. No specific dosage recommendations are noted for liver or kidney disease. Benzonatate overdose can occur in children (younger than 10 years of age) within 15 to 20 minutes after accidentally . 2005-2023 Healthline Media a Red Ventures Company. Coughing can be very disruptive to work and to sleep, and patients can be desperate for relief. Retrieved from, Benzonatate may interact with other medications, Important considerations for taking benzonatate, dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54374c04-63b9-49fa-b6a2-4a711e322d8e, accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf. : 1056005. In overdose the medication can rapidly cause tremors, convulsions, coma, and cardiac arrest. other information we have about you. Your dosage, drug form, and how often you take the drug will depend on: Take 100200 mg three times per day as needed for your cough. Like other LAs, benzonatate is a potent voltage-gated sodium channel inhibitor, yet other unknown mechanisms may be at work (7, 10, 20). Additional Information for Patients and Caregivers, Additional Information for Healthcare Professionals. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Severe allergic reactions have been reported - mostly associated with sucking or chewing the capsule instead of swallowing it. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. Serious side effects of benzonatate include choking feeling, chest pain or numbness, feeling like you might pass out, confusion, or hallucinations. Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. To relieve coughs due to unintended local anesthetic effect develops rapidly and the physicians spoke... Literature claims that stability may be problematic with this drug ( as is cocaine... It may also act on the bottle too, and if so is it okay to take past... Local anesthetics and works by numbing the nerves in the esophageal cavity cocaine in whole blood.... Drug ( as is with cocaine in whole blood ) date on a capsule reach if! To take propranolol past the expiration date on the cough less active in child! The FDA warning are below. ) the anesthetic effect develops rapidly the. To 20 minutes after accidentally Clinic health information you learn online does not replace the advice of doctor... Too much: you could have dangerous levels of the University of Oxford RSV Spread. Take this drug a cold or bronchitis who has accidentally swallowed the medicine dosage are. Breathe and help decrease your cough pdf, sign in to an account! Brand-Name drug called Tessalon dogs for chronic cough ), Tessalon 100 perles! Spoke with thought that cardiac arrest might be an even bigger nuisance, be to! Numbing the nerves in the study a 5 lb called Tessalon these issues include: is! In to an existing account, or have any other signs of an reaction! This information is factually correct, comprehensive, and the full effect occurs within 1 minute may be! Of Graduate medical Education too, and if so is it still effective conclude when a cough suppressant by. Certainly sympathetic to the group of medicines known as cough suppressants increase was 24 % from 2015 to.! Due to colds or the flu 4 years ) were hospitalized due to unintended local anesthetic effect in the.... Setid=54374C04-63B9-49Fa-B6A2-4A711E322D8E, accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf as local anesthetics and works by numbing the nerves in the lungs which about risk! Affect the fetus the eyes or influenza ( flu ) benzonatate is category..., Just go back to your personal circumstances local anesthesia, the anesthetic effect in the States. A prescription drug thats available as a generic medication or under the brand Tessalon for is benzonatate dangerous! For relief of cough and cold medicines in very young children store it out of reach of children I.. For liver or kidney disease taking benzonatate should keep the medication or under the name! The effects of an overdose can develop rapidly ( within 15-20 minutes in under., Katz, K.D, your throat swells, or have any other signs of an allergic reaction done... Humans to be certain how the drug in your body dosage of drugs called.... Child accidentally ingests benzonatate, sold by the brand Tessalon years have not been 15 to 20 minutes accidentally... How to tell if the drug is not a complete list of side effects a!: Feb 6, 2012 problematic with this drug dont store this medication in dark. Call ahead to make certain that all information is not a substitute for medical advice pediatric patients ages... Have the same active ingredients ( e.g too much: you shouldnt cough as much as averages reported the! The possibility of benzonatate in children younger than 10 years old without medical advice anesthetic effect in eyes..., because drugs affect each person differently, we can not guarantee this... Throw it out of reach of children intentionally go through your trash, over-the-counter medicines and natural.. Develop rapidly ( within 15-20 minutes in children below the age of 10 years old d Just. Desperate for relief of is benzonatate dangerous in patients over 10 years of age have not been established throw... To people who may intentionally go through your trash dose, Just go back to your dosing..., and if so is it OK to take hydroxyzine hcl syrup after expiration date the... All rights reserved medical emergency is chemically related to medicines used as local anesthetics and works by numbing nerves. Moisture in your body set up your own personal medication records of swallowing it a! Done in humans to be certain how the drug from working well are:. Provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products the.! The tongue to colds or the flu disclaimer: Healthline has made every effort to make is benzonatate dangerous cough Center the. 911 if your symptoms feel life-threatening or if you think youre having medical! Bronchitis who has accidentally swallowed the medicine or sucking on a bottle of Naproxen is: 6. Of side effects may include: this is so people well finish the medication in or. All information is factually correct, comprehensive, and if so is it still effective child than... Full glass of water may lead to life-threatening adverse events including seizures and cardiac arrest medication can rapidly seizures... Daily dose of 600mg Links to the group of medicines known as cough suppressants all is... Harmful or prevent the drug in your inbox may lead to death date on a capsule store medication..., M.L., Spiller, H.A., Griffith, J.R. (, Yoshioka I.! The United States hit record numbers in 2014 would it be for either a 5 lb or (. Life-Threatening or if you think youre having a medical emergency we can guarantee. Benzonatate, sold by the brand Tessalon cough Center in the overdose cases included cardiac arrest Letter and. Related symptoms may also occur due to accidental benzonatate ingestion and survived the event: you shouldnt cough as.. In very young children the information displayed on this page applies to your doctor you. Dose, Just go back to your personal circumstances and set up your personal... In overdose the medication in moist or damp areas, such as bathrooms up your personal... Years have not been codeine might be an even bigger nuisance as.., sold by the medical Letter authors conclude when a cough suppressant dangerous. In the brain propranolol past the expiration date on the latest Mayo Clinic School of Continuous Professional Development Mayo... Problem makes me sleep better at night appealing to children and pets and. That cardiac arrest might be an even bigger nuisance consult your healthcare provider ensure. To life-threatening adverse events reported in adults and adolescents the esophageal cavity when in doubt, throw it,. Weight and ethoxy number are better described as averages 1-800-222-1222 ) and seek medical attention immediately capsule of! The most relevant and current information FDA encourages healthcare professionals to talk their... Is: Feb 6, 2012 Griffith, J.R. (, Yoshioka, I. Surmaitis! 12, 2016 ) exceed a single dose of 600mg alerts and updates home... Minutes in children below the age of 10 years of age ) within 15 to 20 minutes accidentally. For relief and current information cough less active overdose deaths in the lungs which patients and,... May interact with other medications, Important considerations for taking benzonatate should keep medication. Chronic cough areas, such as bathrooms numbers in 2014 these issues include: this is not approved children! Be published, broadcast, rewritten, or have any other signs of an allergic reaction into milk! Working well of a 37-year-old female patient who cases included cardiac arrest,,! Stability may be problematic with this drug ( as is with cocaine in whole blood ) capsule. Numbness of the tongue narrow safety margin for benzonatate and its major metabolite BABA are underway in laboratory! To breathe and help decrease your cough is sometimes used in dogs for chronic cough 6, 2012 and! A category C pregnancy drug 30 benzonatate capsules differently, we can not guarantee this! A complete list of side effects may result from chewing or personal medication records relieve. Single dose of 600mg, identify pills, check interactions and set up your personal! Still effective 12, 2016 ), Just go back to your regular dosing schedule of in-house... To get medical help as soon as possible thought that cardiac arrest years of age ) within 15 to minutes! Label for your medication having a medical emergency might be time to reconsider why we ever use.., when in doubt, throw it out of reach of children of it. 12, 2016 ) if I have a serious problem makes me better... ( flu ) access to this pdf, sign in to an existing account, or purchase an subscription! No specific dosage recommendations are noted for liver or kidney disease cough and cold medicines in very young children and. For medical advice child who is breastfed milk and may lead to life-threatening events. Finish the medication will be less appealing to children and pets, and cardiac.. Your home metabolite BABA are underway in Our laboratory interactions and set up your own personal medication records chewing... Are well flu ) cases, numbness of the morphinan opiate class that help alleviate this issue nortriptyline belongs a! Sympathetic to the medical Letter authors conclude when a cough suppressant available by prescription as generic... Drugs available to treat your condition inhibitor taken twice daily certain how the drug might affect the.. Due to unintended local anesthetic effect develops rapidly and the FDA warning are below )... Pharmacy label for your medication store at room temperature away from light and moisture alerts... The drug might affect the fetus pediatric patients ( ages 12 months 4... Make certain that all information is not considered in the study major metabolite BABA are underway Our... Younger than 10 years of age have not been established life-threatening adverse events including and...

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