United States - English - NLM (National Library of Medicine)
BENZONATATE- benzonatate capsule
Benzonatate Capsules, USP
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 for oral administration contains 100 mg or 200 mg of benzonatate. In addition,
each capsule also contains the following inactive ingredients: gelatin, glycerin, noncrystallising
sorbitol solution, methylparaben, propylparaben and purified water.
Benzonatate capsules act 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 capsules
have no inhibitory effect on the respiratory center in recommended dosage.
INDICATIONS AND USAGE
Benzonatate capsules are indicated for the symptomatic relief of cough.
Hypersensitivity to benzonatate or related compounds.
Hypers ens itivity
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
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 to 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 capsules 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 to 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
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 capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2
doses of benzonatate capsules at one time.
Usage in Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate capsules.
It is also not known whether benzonatate capsules can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. Benzonatate capsules should be given to a pregnant woman
only if clearly needed.
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 are administered to a nursing woman.
Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate
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 Capsules may include: Hypersensitivity reactions including
bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from
chewing or sucking the capsule.
Sedation; headache; dizziness; mental confusion; visual hallucinations.
Constipation; nausea; GI upset.
Pruritus; skin eruptions.
Nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest;
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 to 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.
In case of overdose, seek 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.
DOSAGE AND 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.
Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules,
imprinted with "Z" containing pale yellow-colored clear viscous liquid and are supplied as follows:
Overbagged with 10 Capsules per bag, NDC 55154-7995-0
Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-
Cadila Healthcare Ltd.
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534
31778 Enterprise Drive
Livonia, MI 48150
Dublin, OH 43017
Package/Label Display Panel
Benzonatate Capsules, USP
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:55154-79 9 5(NDC:0 9 0 4-6 56 4)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
BENZO NATATE (UNII: 5P4DHS6 ENR) (BENZONATATE - UNII:5P4DHS6 ENR)
10 0 mg
Stre ng th
GLYCERIN (UNII: PDC6 A3C0 OX)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PRO PYLPARABEN (UNII: Z8 IX2SC1OH)
SO RBITO L (UNII: 50 6 T6 0 A25R)
WATER (UNII: 0 59 QF0 KO0 R)
GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)
YELLOW (LIGHT YELLOW)
no sco re
S hap e
S iz e
Marketing Start Date
Marketing End Date
NDC:55154-79 9 5-0
10 in 1 BAG
0 9 /0 4/20 0 7
1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
ANDA0 40 59 7
0 9 /0 4/20 0 7
Cardinal Health (603638201)