Label: BENZONATATE capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 58177-091-04, 58177-091-08, 58177-091-11, 58177-092-04 - Packager: ETHEX Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 30, 2008
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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 capsule contains benzonatate, USP, 100 mg or 200 mg.
Benzonatate capsules, USP also contain gelatin, glycerin, methyl/propyl paraben blend, purified water, and titanium dioxide.
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CLINICAL PHARMACOLOGY
Benzonatate 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 has no inhibitory effect on the respiratory center in recommended dosage.
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
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WARNINGS
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.
Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules, USP in combination with other prescribed drugs.
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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 a prior sensitivity to related agents or interaction with concomitant medication.
Information for Patients
Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. Therefore, the capsules should be swallowed without chewing.
Usage in Pregnancy – Pregnancy Category C
Animal reproduction studies have not been conducted with benzonatate capsules, USP. It is also not known whether benzonatate capsules, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate capsules, USP should be given to a 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, USP are administered to a nursing woman.
- ADVERSE REACTIONS
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OVERDOSAGE
Overdose may result in death.
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
If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly. CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression.
Treatment
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 a 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.
- DOSAGE AND ADMINISTRATION
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HOW SUPPLIED
Benzonatate capsules, USP 100 mg are round, white soft gelatin capsules, imprinted in black ink “E,” packaged as follows:
NDC 58177-091-04 bottle of 100 capsules
NDC 58177-091-08 bottle of 500 capsules
NDC 58177-091-11 unit dose package of 100 capsules (10 capsules per blister card)
Benzonatate capsules, USP 200 mg are oval, white soft gelatin capsules, imprinted in black ink “E2,” packaged as follows:
NDC 58177-092-04 bottle of 100 capsules
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from light.
Dispense in a tight, light resistant container as defined in the USP.
Manufactured by
AccuCaps
Windsor, Ontario, Canada
for
ETHEX Corporation
St. Louis, MO 63044 USAP5519-1 01/08
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INGREDIENTS AND APPEARANCE
BENZONATATE
benzonatate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58177-091 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzonatate (UNII: 5P4DHS6ENR) (Benzonatate - UNII:5P4DHS6ENR) 100 mg Inactive Ingredients Ingredient Name Strength gelatin (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) methyl/propyl paraben blend () water (UNII: 059QF0KO0R) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color white (WHITE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code E Contains Coating false Symbol false Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58177-091-04 100 in 1 BOTTLE 2 NDC:58177-091-08 500 in 1 BOTTLE 3 NDC:58177-091-11 100 in 1 BLISTER PACK BENZONATATE
benzonatate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58177-092 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzonatate (UNII: 5P4DHS6ENR) (Benzonatate - UNII:5P4DHS6ENR) 200 mg Inactive Ingredients Ingredient Name Strength gelatin (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) methyl/propyl paraben blend () water (UNII: 059QF0KO0R) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color white (WHITE) Score no score Shape OVAL (OVAL) Size 11mm Flavor Imprint Code E2 Contains Coating false Symbol false Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58177-092-04 100 in 1 BOTTLE Labeler - ETHEX Corporation
