BENZONATATE- benzonatate capsule
Bryant Ranch Prepack
BENZONATATE CAPSULES USP, 100 mg and 200 mg
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 soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In
addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin,
glycerin, and purified water.
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
BENZONATATE is 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 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 15-20 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
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, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses
of BENZONATATE at one time.
Usage in Pregnancy:
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.
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
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
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.
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.
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 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 with “PA46”, available in
bottles of 100’s and 500’s.
Benzonatate Capsules USP, 200 mg: Yellow soft gelatin capsules, imprinted with “PA83”, available in
bottles of 100’s.
The capsules should be protected from light, moisture and humidity, and stored at controlled room
temperature 20° to 25°C (68° to 77°F) [See USP].
Dispense in a tight, light-resistant container as defined in USP/NF.
BANNER PHARMACAPS INC.;
High Point, NC 27265
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Revised February 2011
Benzonatate Capsule 100mg
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:6 36 29 -26 55(NDC:50 111-8 51)
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
D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G8 6 QN327L)
GLYCERIN (UNII: PDC6 A3C0 OX)
WATER (UNII: 0 59 QF0 KO0 R)
Bryant Ranch Prepack
no sco re
S hap e
S iz e
Marketing Start Date Marketing End Date
NDC:6 36 29 -26 55-1
30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
NDC:6 36 29 -26 55-2
20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
NDC:6 36 29 -26 55-3
10 0 in 1 BOTTLE; Type 1: Co nvenience Kit o f Co -Package
NDC:6 36 29 -26 55-4
15 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
NDC:6 36 29 -26 55-5
120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
NDC:6 36 29 -26 55-6
6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
NDC:6 36 29 -26 55-7
9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
NDC:6 36 29 -26 55-8
14 in 1 BOTTLE; 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 8 129 7
0 4/0 1/19 9 3
Bryant Ranch Prepack (171714327)
Bryant Ranch Prepack (171714327)
Ad d re s s
Busine ss Ope rations
Bryant Ranch Prepack
REPACK(6 36 29 -26 55) , RELABEL(6 36 29 -26 55)