Generic Name: benzonatate softgels Brand Name: Benzonatate Drug Class: Antitussives Related Drugs Triacin C Tussigon Related Supplements Andrographis Echinacea Zinc Benzonatate User Reviews What Is Benzonatate? Benzonatate is a nonnarcotic antitussive (anti-cough) drug used to relieve cough symptoms. Benzonatate is available in generic form. What Are Side Effects of Benzonatate? Benzonatate may cause serious side effects including: difficulty breathing, difficulty speaking, visual hallucinations, shortness of breath, tightness in the chest, and Get medical help right away, if you have any of the symptoms listed above. Common side effects of benzonatate include: hypersensitivity reactions, visual hallucinations, skin breakouts, burning in the eyes, and Seek medical care or call 911 at once if you have the following serious side effects: Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out; Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors. This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects. Dosage for Benzonatate The usual dose of benzonatate for adults and children over 10 years of age is one 100 mg softgel three times daily as required. If necessary, up to 6 softgels daily may be given. What Drugs, Substances, or Supplements Interact with Benzonatate? Benzonatate may interact with other medications that cause drowsiness including, cough and cold medications, antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotics, or psychiatric medicines. Tell your doctor all medications and supplements you use. Benzonatate During Pregnancy and Breastfeeding During pregnancy, benzonatate should be used only if prescribed. It is unknown if this drug is excreted in breast milk. Consult your doctor before breastfeeding. Additional Information Our Benzonatate Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Hypersensitivity Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures. Psychiatric Effects Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate in combination with other prescribed drugs. Accidental Ingestion And Death In Children Keep benzonatate out of reach of children. Accidental ingestion of benzonatate resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSE ). Description for Benzonatate Benzonatate, a non-narcotic antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate, USP. Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin, glycerin, methylparaben sodium and propylparaben sodium. Uses for Benzonatate Benzonatate is indicated for the symptomatic relief of cough. Dosage for Benzonatate Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

Benzonatate Capsules, USP are available as: 100 mg (oval, yellow) soft gelatin capsules with imprint “A5”. NDC 62332-426-31 Bottles of 100 NDC 62332-426-71 Bottles of 500 200 mg (oblong, yellow) soft gelatin capsules with imprint “A6”. NDC 62332-427-31 Bottles of 100 NDC 62332-427-71 Bottles of 500 Store at 20° to 25°C (68° to 77°F); excurs ions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Swiss Caps AG Kirchberg, Switzerland. Revised: Nov 2018 Side Effects for Benzonatate Potential Adverse Reactions to benzonatate may include: Hypersens itivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. CNS: sedation; headache; dizziness; mental confusion; visual hallucinations. GI: constipation, nausea, GI upset. Dermatologic: pruritus; skin eruptions. Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity. Deliberate or accidental overdose has resulted in death, particularly in children. Drug Interactions for Benzonatate No Information Provided Warnings for Benzonatate No Information Provided Precautions for Benzonatate Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g., procaine ; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication. Usage In Pregnancy Animal reproduction studies have not been conducted with benzonatate. It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzonatate is administered to a nursing woman. Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate. Safety and effectiveness in children below the age of 10 has not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children. Overdose Information for Benzonatate Intentional and unintentional overdose may result in death, particularly in children. The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion. Signs And Symptoms The signs and symptoms of overdose of benzonatate have been reported within 15 to 20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion. In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage. Do not use CNS stimulants. Contraindications for Benzonatate Hypersensitivity to benzonatate or related compounds. Clinical Pharmacology for Benzonatate Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage. Patient Information for Benzonatate Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or crush benzonatate capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention. Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15 to 20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately. Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total daily dose of 600 mg. If you miss a dose of benzonatate, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate at one time. What Are the Best PsA Treatments for You? Understanding Biologics 10 Things People With Depression Wish You Knew Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.