TESSALON (benzonatate, USP)100 mg Pereles200 mg CapsulesRx Only

TESSALON  - benzonatate capsule 
Physicians Total Care, Inc.

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DESCRIPTION

TESSALON, 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.

Benzonatate_Chem_Structure.jpg

Each TESSALON Perle contains:

Benzonatate, USP 100 mg

Each TESSALON Capsule contains:

Benzonatate, USP 200 mg

TESSALON Capsules also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben.

CLINICAL PHARMACOLOGY

TESSALON 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. TESSALON has no inhibitory effect on the respiratory center in recommended dosage.

INDICATIONS AND USAGE

TESSALON is indicated for the symptomatic relief of cough.

CONTRAINDICATIONS

Hypersensitivity to benzonatate or related compounds.

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 TESSALON in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep TESSALON out of reach of children. Accidental ingestion of TESSALON 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).

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

Swallow TESSALON Capsules and Perles whole. Do not break, chew, dissolve, cut, or crush TESSALON Capsules and Perles. Release of TESSALON 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 TESSALON 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 TESSALON, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of TESSALON at one time.

Usage in Pregnancy

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with TESSALON. It is also not known whether TESSALON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TESSALON 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 TESSALON is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON.

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.

ADVERSE REACTIONS

Potential Adverse Reactions to TESSALON 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.

OVERDOSAGE

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.

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. TESSALON should be swallowed whole. TESSALON Capsules and Perles are not to be broken, chewed, dissolved, cut or crushed.

HOW SUPPLIED

Perles, 100 mg (yellow);

Bottles of 20
NDC 54868-0714-1

Imprint: T.


Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Rev. 12/15

Mfd by

Catalent Pharma Solutions

St. Petersburg, Florida 33716

Pfizer Inc.

Madison, New Jersey 07940

©2010 Pfizer Inc.



Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK      74146

PRODUCT PACKAGING

TESSALON 100 mg  (benzonatate, USP) perles/capsules

See package insert for dosage information

Dispensing package for professional use only.

Dispense in a tight, light-resistant container as defined in the USP.

KEEP TIGHTLY CLOSED

image of No Label Available


TESSALON 
benzonatate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-0714(NDC:0069-0122)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzonatate (benzonatate) benzonatate100 mg
Inactive Ingredients
Ingredient NameStrength
D&C Yellow No. 10 
Gelatin 
Glycerin 
Methylparaben 
Propylparaben 
Product Characteristics
ColorYELLOWScore no score
ShapeROUNDSize7mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54868-0714-120 CAPSULE ( CAPSULE) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01121002/10/195807/31/2011

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel, repack

Revised: 02/2011 Physicians Total Care, Inc.