Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Benzonatate Capsule is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds.
Benzonatate Capsules USP , 200 mg are available as yellow, oval soft gelatin capsules with '2' imprinted in white ink. NDC: 70518-3542-00 NDC: 70518-3542-01 NDC: 70518-3542-02 NDC: 70518-3542-03 NDC: 70518-3542-04 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 21 in 1 BOTTLE PLASTIC PACKAGING: 28 in 1 BOTTLE PLASTIC PACKAGING: 15 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
BENZONATATE- BENZONATATE CAPSULE REMEDYREPACK INC. ---------- BENZONATATE CAPSULES USP, 100 MG AND 200 MG DESCRIPTION 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. Each Benzonatate Capsules USP contains: Benzonatate, USP 100 mg or 200 mg. Benzonatate Capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben, propylparaben and titanium dioxide. CLINICAL PHARMACOLOGY Benzonatate Capsule 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 Capsule has no inhibitory effect on the respiratory center in recommended dosage. INDICATIONS AND USAGE Benzonatate Capsule is indicated for the symptomatic relief of cough. CONTRAINDICATIONS Hypersensitivity to benzonatate or related compounds. 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 Capsule 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). PR read_full_document