Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Benzonatate capsules USP, 100 mg are available as yellow colored, oval shaped soft gelatin capsules, imprinted as '705' in white ink and containing clear, pale yellow viscous liquid. Blistercards of 30 NDC 0615-8403-39 Blistercards of 21 NDC 0615-8403-21 Blistercards of 15 NDC 0615-8403-05 Benzonatate capsules USP, 200 mg are available as yellow colored, oval shaped soft gelatin capsules, imprinted as '704' in white ink and containing clear, pale yellow viscous liquid. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP controlled room temperature]. PROTECT FROM LIGHT Dispense in a tight (USP), child-resistant containers. Manufactured by: Strides Pharma Science Ltd. Bengaluru – 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Rx Only Revised: 05/2019; PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL
- HOW SUPPLIED Benzonatate capsules USP, 100 mg are available as yellow colored, oval shaped soft gelatin capsules, imprinted as '705' in white ink and containing clear, pale yellow viscous liquid. Blistercards of 30 NDC 0615-8403-39 Blistercards of 21 NDC 0615-8403-21 Blistercards of 15 NDC 0615-8403-05 Benzonatate capsules USP, 200 mg are available as yellow colored, oval shaped soft gelatin capsules, imprinted as '704' in white ink and containing clear, pale yellow viscous liquid. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP controlled room temperature]. PROTECT FROM LIGHT Dispense in a tight (USP), child-resistant containers. Manufactured by: Strides Pharma Science Ltd. Bengaluru – 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Rx Only Revised: 05/2019
- PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL
Overview
Benzonatate capsules USP 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 capsule USP, 100 mg contains: Benzonatate USP 100 mg Each benzonatate capsule USP, 200 mg contains: Benzonatate USP 200 mg Benzonatate capsules USP also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben. Ingredients of the imprinting ink are: Propylene glycol, shellac resins, sodium lauryl sulphate, isopropyl alcohol and titanium dioxide. Chemical structure
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 USP should be swallowed whole. Benzonatate capsules USP 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 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 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. Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com
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