CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Benzonatate capsules act 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 to hours. Benzonatate capsules have no inhibitory effect on the respiratory center in recommended dosage.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Hypersensitivity to benzonatate or related compounds.

DESCRIPTION SECTION.

DESCRIPTION. Benzonatate capsules, USP, non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with molecular weight of 603.7.Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow 10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.. structure formula.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate capsules should be swallowed whole. Benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Potential Adverse Reactions to benzonatate capsules may include:Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.CNSsedation; headache; dizziness; mental confusion; visual hallucinations.GIconstipation; nausea; GI upset.Dermatologicpruritus; skin eruptions.Othernasal 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.. Hypersensitivity reactions. including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility. Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate capsules.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Benzonatate Capsules USP, 100 mg are clear yellow, oval-shaped softgel capsules imprinted with PC14 and are supplied as follows:Cartons of 100 capsules (10 capsules each blister pack 10), NDC 0904-7153-61Store at 20 to 25 (68 to 77 F) [see USP Controlled Room Temperature].PROTECT FROM LIGHTDispense in tight (USP), child-resistant containers.Rx OnlyManufactured by:Humanwell PuraCap PharmaceuticalWuhan, Hubei 430206, ChinaDistributed by:Epic Pharma, LLCLaurelton, NY 11413Distributed By:MAJOR(R) PHARMACEUTICALSLivonia, MI 48152Refer to package label for Distributors NDC Number Rev. 10-2018-00PI-EBEN-00.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Benzonatate capsules, USP are indicated for the symptomatic relief of cough.

INFORMATION FOR PATIENTS SECTION.

Information for Patients:. 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 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 capsules out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 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 single dose of 200 mg and total daily dosage of 600 mg. If you miss dose of benzonatate capsules, skip that dose and take the next dose at the next scheduled time. Do not take doses of benzonatate capsules at one time.

NURSING MOTHERS SECTION.

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 capsules are administered to nursing woman.

OVERDOSAGE SECTION.

OVERDOSAGE. 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 capsules have been reported within 15-20 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 hour of ingestion.. Treatment. 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 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package/Label Display Panel Benzonatate Capsules, USP100 mg100 Capsules. Carton label.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

PRECAUTIONS SECTION.

PRECAUTIONS. 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 prior sensitivity to related agents or interaction with concomitant medication.. Information for Patients:. 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 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 capsules out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 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 single dose of 200 mg and total daily dosage of 600 mg. If you miss dose of benzonatate capsules, skip that dose and take the next dose at the next scheduled time. Do not take doses of benzonatate capsules at one time.. Usage in Pregnancy. PREGNANCY CATEGORY CAnimal reproduction studies have not been conducted with benzonatate capsules. It is also not known whether benzonatate capsules can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Benzonatate capsules should be given to 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 capsules are administered to nursing woman.. Carcinogenesis, Mutagenesis, Impairment of Fertility. Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate capsules... Pediatric Use. Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

PREGNANCY SECTION.

Usage in Pregnancy. PREGNANCY CATEGORY CAnimal reproduction studies have not been conducted with benzonatate capsules. It is also not known whether benzonatate capsules can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Benzonatate capsules should be given to pregnant woman only if clearly needed.

SPL UNCLASSIFIED SECTION.

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.

WARNINGS SECTION.

WARNINGS. 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 capsules in combination with other prescribed drugs.. Accidental Ingestion and Death in Children. Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).