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Exall Liquid

Generic Name: carbetapentane citrate and guaifenesin
Dosage Form: liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Exall Liquid

Exall Liquid

Rx Only
Antitussive / Expectorant

DESCRIPTION: ExallTM Liquid is alcohol-free, dye-free, sugar-free, colorless liquid for oral administration having a cherry odor and flavor.

Each teaspoonful (5 mL) for oral administration contains:
Carbetapentane Citrate........................ 10 mg
Guaifenesin.......................................100 mg

Inactive ingredients: Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Carbetapentane Citrate (1-Phenylcyclopentanecarboxylic acid 2-(2-diethylaminoethoxy) ethyl ester citrate) is a white crystalline powder.
It is freely soluble in water and chloroform. Its structure is as follows:



Guaifenesin (1,2-Propanediol, 3-(2-methoxyphenoxy)-, (±)-) is a white to slightly gray, crystalline powder, having a bitter taste.
It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol. Its structure is as follows:


CLINICAL PHARMACOLOGY:

Antitussive and expectorant actions.

Carbetapentane Citrate is a centrally acting non-narcotic antitussive. Carbetapentane citrate has atropine-like and local anesthetic actions,
as well as temporarily controls and suppresses the cough reflex by selective depression of the medullary cough center. It has no significant
analgesic or sedative properties, does not depress respiration or predispose to addiction with usual doses.

Guaifenesin has an expectorant action, which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension.
By increasing respiratory tract fluid, guaifenesin reduces the viscosity of secretions, and facilitates expectoration of retained secretions.
Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and renally excreted. Guaifenesin has a plasma
half-life of one hour. The major urinary metabolite is beta-(2-methoxyphenoxy) lactic acid. Sinus and bronchial drainage is improved and dry,
non-productive coughs become more productive and less frequent. Guaifenesin helps loosen phlegm (mucus) and thin bronchial secretions
to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.

INDICATIONS AND USAGE:

For temporary relief of productive and non-productive cough accompanying respiratory tract congestion associated with the common
cold, influenza, sinusitis, and bronchitis.

CONTRAINDICATIONS:

ExallTM Liquid is contraindicated in infants and newborns, and in patients with a known hypersensitivity to any of the ingredients
and in patients receiving monoamine oxidase inhibitor (MAOI) therapy, including 14 days after stopping.

WARNINGS:

General: Before prescribing any medication to suppress or modify cough, it is important that the underlying cause of the cough is identified.

Information for Patients:

Patients should be instructed to take ExallTM Liquid only as prescribed. Do not exceed the recommended dose. If nervousness,
dizziness, or sleeplessness occur, discontinue use and consult a physician.

Drug/Laboratory Test Interactions:

Carbetapentane citrate should not be used in patients receiving MAO inhibitors, including 14 days after stopping the MAOI drug.
The use of carbetapentane citrate may result in additive CNS depressant effects when coadministered with alcohol, antihistamines,
psychotropics or other drugs that produce CNS depression.

Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of
this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this
drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

No adequate and well-controlled studies have been conducted to determine whether the components of ExallTM  Liquid
have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not been conducted with this product. It is also not known whether it can
cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should not be administered
to pregnant women.

Nursing Mothers:

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Pediatric use:

Safety and effectiveness in pediatric patients below the age of six have not been established. Product not intended for administration
for children 6 years of age and under.

ADVERSE REACTIONS:

Adverse effects associated with carbetapentane citrate are rare, but nausea and/or other gastrointestinal disturbances sometimes occur.
Guaifenesin is well tolerated and has a wide margin of safety. Adverse effects associated with guaifenesin usually result from doses larger
than those required for expectoration.

OVERDOSAGE:

Signs and Symptoms: Overdosage with carbetapentane citrate may produce central excitement and mental confusion. Guaifenesin is
unlikely to produce toxic effects since its toxicity is low. When laboratory animals were administered guaifenesin in doses up to 5 g/kg
by stomach tube, no toxicity resulted.

Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the
administration of ipecac liquid is a preferred method, however, vomiting should not be induced in patients with impaired consciousness.
Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach
may be absorbed by activated charcoal administered as a slurry with water.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and older:
1-2 teaspoonfuls (5-10 mL) every 4-6 hours, not to exceed 12 teaspoonfuls in a 24 hour period.
Children 6 to 12 years of age:
1 teaspoonful (5 ml) every 4-6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.
Children under 6 years of age:
Consult a physician.

HOW SUPPLIED:

ExallTM Liquid is a colorless, cherry flavored liquid and supplied in bottles of 16 fl oz (473 mL), NDC 63717-554-16, or samples
of 1/2 fl oz (15 mL), NDC 63717-554-99.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE,
CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant closure.

Rx Only

Manufactured for:
Hawthorn Pharmaceuticals, Inc.
Madison, MS 39110

HI255   08/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used.

NDC 63717-554-16

ExallTM Liquid

Antitussive / Expectorant

Each teaspoonful (5 mL) for oral administration contains:
Carbetapentane Citrate..... 10 mg
Guaifenesin.................... 100 mg

Rx Only

Dye Free/Sugar Free/Alcohol Free

Hawthorn Pharmaceuticals, Inc.

16 fl oz (473 mL)


Side Panel:

USUAL DOSAGE: See Package Insert for Complete Dosage Recommendations.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON
CONTROL CENTER IMMEDIATELY.

Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

This bottle is not to be dispensed to the consumer. Dispense in a tight, light-resistant container with a child-resistant closure.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (Toll Free).

Manufactured for: Hawthorn Pharmaceuticals, Inc., Madison, MS 39110

HL209   08/09

Exall Liquid 
carbetapentane citrate, guaifenesin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63717-554
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbetapentane Citrate (Carbetapentane) Carbetapentane Citrate 10 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:63717-554-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 08/24/2009
Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)
Revised: 08/2009
 
Hawthorn Pharmaceuticals, Inc.



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