NDC 0440-1185 Benzonatate

NDC Product Code 0440-1185

NDC 0440-1185-10

Package Description: 10 CAPSULE in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Benzonatate with NDC 0440-1185 is a product labeled by Liberty Pharmaceuticals, Inc.. The generic name of Benzonatate is . The product's dosage form is and is administered via form.

Labeler Name: Liberty Pharmaceuticals, Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Liberty Pharmaceuticals, Inc.
Labeler Code: 0440
Start Marketing Date: 07-25-2007 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Benzonatate

Benzonatate is pronounced as (ben zoe' na tate)

Why is benzonatate medication prescribed?
Benzonatate is used to relieve cough. Benzonatate is in a class of medications called antitussives (cough suppressants). It works by reducing the cough reflex in the lung...
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Benzonatate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 soft gelatin capsule, for oral administration, contains 100 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.

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

Benzonatate is indicated for the symptomatic relief of cough.

Contraindications

Hypersensitivity to benzonatate or related compounds.

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 in combination with other prescribed drugs.

Precautions

Benzonatate is chemically related to anesthetic agents of the para-aminobenzoic 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. 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.

Adverse Reactions

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.Rare instances of deliberate or accidental overdose have resulted in death.

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

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule t.i.d. as required. If necessary, up to 600 mg daily may be given.

How Supplied

Benzonatate Capsules USP, 100 mg: Yellow soft gelatin capsules, imprinted “ASC” on one side and “105” on the other side, available in bottles of 10’s (NDC 00440-1185-10). Store at controlled room temperature 20º - 25ºC (68º - 77ºF) [See USP].API-01, 5/07Mfd byIntergel Division of IVC Industries, Inc.Irvington, NJ 07111Repackaged By:Aidarex Pharmaceuticals, LLCCorona, CA 92880

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