Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 10,14,15,20,21,30,and 40. Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Manufactured by Intergel Division of IVC Industries, Inc. Irvington, NJ 07111 Manufactured for Ascend Laboratories, LLC Montvale, NJ 07645 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev 02/17 210082; Principal Display Panel NDC 63187-928-20 Benzonatate Capsules, USP 100 mg Rx only 20 Capsules 63187-928-20
- HOW SUPPLIED Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted "105", available in bottles of 10,14,15,20,21,30,and 40. Store at 20° to 25° C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Manufactured by Intergel Division of IVC Industries, Inc. Irvington, NJ 07111 Manufactured for Ascend Laboratories, LLC Montvale, NJ 07645 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev 02/17 210082
- Principal Display Panel NDC 63187-928-20 Benzonatate Capsules, USP 100 mg Rx only 20 Capsules 63187-928-20
Overview
Benzonatate, a non-narcotic oral 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. C 30 H 53 NO 11 Each soft gelatin capsule, for oral administration, contains 100 mg, 150 mg or 200 mg of benzonatate USP. Benzonatate Capsules, USP also contain the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, purified water, methylparaben, propylparaben and titanium dioxide Chemical Structure
Indications & Usage
Benzonatate USP is indicated for the symptomatic relief of cough.
Dosage & Administration
Adults and Children over 10 years of age: Usual dose is one 100 mg, 150 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.
Warnings & Precautions
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 Efects 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 capsules 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 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE ).
Contraindications
Hypersensitivity to benzonatate or related compounds.
Adverse Reactions
Potential Adverse Reactions to benzonatate may include: Hypersensitivity 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.
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