Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Benzonatate Capsules USP, 200 mg are clear yellow, oval-shaped softgel capsules imprinted with PC15 and are supplied as follows: NDC 68071-1395-3 BOTTLES OF 30 NDC 68071-1395-5 BOTTLES OF 45 Store at 20˚ to 25˚ C (68˚ to 77˚ F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT Dispense in tight (USP), child-resistant containers. Rx Only Manufactured by: Humanwell PuraCap Pharmaceutical Wuhan, Hubei 430206, China Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 10-2018-00 PI-EBEN-00; PDP
- HOW SUPPLIED Benzonatate Capsules USP, 200 mg are clear yellow, oval-shaped softgel capsules imprinted with PC15 and are supplied as follows: NDC 68071-1395-3 BOTTLES OF 30 NDC 68071-1395-5 BOTTLES OF 45 Store at 20˚ to 25˚ C (68˚ to 77˚ F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT Dispense in tight (USP), child-resistant containers. Rx Only Manufactured by: Humanwell PuraCap Pharmaceutical Wuhan, Hubei 430206, China Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 10-2018-00 PI-EBEN-00
- PDP
Overview
Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a 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
Indications & Usage
Benzonatate capsules, USP are indicated for the symptomatic relief of cough.
Dosage & Administration
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 capsules 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 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 ).
Contraindications
Hypersensitivity to benzonatate or related compounds.
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. 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. Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
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