BENZONATATE- benzonatate capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR)
Available from:
Direct_Rx
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Benzonatate USP is indicated for the symptomatic relief of cough. Hypersensitivity to benzonatate or related compounds. Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.
Product summary:
Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted “105”, available in bottles of 100’s , and 500’s Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted “128”, available in bottles of 100 Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted “106”, available in bottles of 100’s and 500’s 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 Parsippany, NJ 07054 Rev 03/18 210082
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-573-15

BENZONATATE- benzonatate capsule

Direct_Rx

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BENZONATATE

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.

[Chemical Structure]

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

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.

Benzonatate USP is indicated for the symptomatic relief of cough.

Hypersensitivity to benzonatate or related compounds.

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 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).

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 Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut, or

crush Benzonatate Capsules. Release of benzonatate from the capsule in the mouth can produce a

temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the

tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness

has resolved. If the symptoms worsen or persist, seek medical attention.

Keep benzonatate out of reach of children. Accidental ingestion resulting in death has been reported in

children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been

reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors,

convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.

Overdosage resulting in death may occur in adults. Do not exceed a single dose of 200 mg and a total

daily dosage of 600 mg. If you miss a dose of benzonatate capsule, skip that dose and take the next dose

at the next scheduled time. Do not take 2 doses of benzonatate at one time.

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with benzonatate. It is also not known whether

benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction

capacity. Benzonatate 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 is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity, mutagenicity, and reproduction

studies have not been conducted with benzonatate.

Pediatric Use

Safety and effectiveness in children below the age of 10 have not been established. Accidental

ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

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.

Intentional and unintentional overdose may result in death, particularly in children. 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

The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If

capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which

may cause choking and airway compromise. CNS stimulation may cause restlessness and tremors which

may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma,

cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.

Treatment

In case of overdose, seek medical attention immediately. 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.

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.

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted “105”, available in bottles

of 100’s , and 500’s

Benzonatate Capsules USP, 150 mg: Yellow soft gelatin capsules, imprinted “128”, available in bottles

of 100

Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted “106”, available in bottles

of 100’s and 500’s

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

Parsippany, NJ 07054

Rev 03/18

210082

BENZONATATE

benzonatate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 19 19 -573(NDC:6 78 77-573)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO NATATE (UNII: 5P4DHS6 ENR) (BENZONATATE - UNII:5P4DHS6 ENR)

BENZONATATE

10 0 mg

Dire ct_Rx

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

WATER (UNII: 0 59 QF0 KO0 R)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

GELATIN (UNII: 2G8 6 QN327L)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

CAPSULE

S iz e

19 mm

Flavor

Imprint Code

10 5

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -573-15

15 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/29 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 6 27

0 7/29 /20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -573)

Revised: 7/2019

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