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Exall-D Liquid

Generic Name: carbetapentane citrate, pseudoephedrine hydrochloride, 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-D Liquid

Exall-D Liquid

Rx Only

Antitussive / Nasal Decongestant / Expectorant

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

Each teaspoonful (5 ml) for oral administration contains:
Carbetapentane Citrate................................ 10 mg
Pseudoephedrine Hydrochloride................... 30 mg
Guaifenesin.............................................. 100 mg

Inactive ingredients: Citric Acid, Fruit Gum Flavor, 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:


Pseudoephedrine Hydrochloride is a nasal decongestant with the chemical name Benzenemethanol,
α-[1-(methylamino)ethyl]-, [S-(R*, R*)-, hydrochloride. 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:


Exall-D Liquid - Clinical Pharmacology

Antitussive, nasal decongestant, 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 pre-dispose to addiction with
usual doses.

Pseudoephedrine hydrochloride is an oral sympathomimetic amine that acts as a nasal
decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is
similar to that of ephedrine, pseudoephedrine has less pressor effect in normotensive adults.
Serum half-life for pseudoephedrine is 6 to 8 hours. Acidic urine is associated with faster
elimination of the drug. About one-half of the administered dose is excreted in the urine.
Pseudoephedrine causes vasoconstriction, which results in reduction of tissue hyperemia,
edema, nasal congestion and an increase in nasal airway patency.

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 Exall-D Liquid

For temporary relief of productive and non-productive cough accompanying respiratory
tract congestion associated with the common cold, influenza, sinusitis, and bronchitis.
For the relief of eustachian tube congestion. For adjunctive therapy in serous otitis media.

Contraindications

ExallTM-D 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. Check with physician if cough persists
after medication has been used for 7 days or if high fever, skin rash, or continued
headache, or sore throat is present with cough. Hypertensive patients should use this
product only with medical advice, as they may experience a change in blood pressure due
to added vasoconstriction.

Sympathomimetic amines should be used judiciously and sparingly in patients with
hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure,
hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous
system stimulation with convulsions or cardiovascular collapse with accompanying
hypotension.

Do not exceed recommended dosage.

If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy
 to lower blood pressure should be instituted. Fever should be managed by means of
external cooling.

Information for Patients:

Patients should be instructed to take ExallTM-D Liquid only as prescribed. If nervousness,
dizziness, or sleeplessness occur, discontinue use and consult a physician.

Drug Interactions:

Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias.
Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine,
methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants
may antagonize the effects of pseudoephedrine. Use of other vasopressor drugs during
halothane anesthesia may cause serious cardiac arrhythmias.

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.

Pseudoephedrine has additive effects with alcohol and other CNS depressants (hypnotics,
sedatives, tranquilizers, etc.). MAO inhibitors prolong and intensify the anticholinergic
(drying) effects of antihistamines and the overall effects of sympathomimetic agents.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

No adequate and well-controlled studies have been conducted to determine whether
the components of ExallTM-D 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.

Geriatric Use:

Patients aged 60 and older are more likely to experience adverse reactions to
sympathomimetics. Overdosage of sympathomimetics in this age group may cause
hallucinations, convulsions, CNS depression, and death. In general, dose selection
for an elderly patient should be cautious, usually starting at the low end of the dosing
range, reflecting the greater frequency of decreased hepatic, renal or cardiac function,
and of concomitant disease or drug therapy.

Adverse Reactions

Adverse effects associated with carbetapentane citrate are rare, but nausea and/or other
gastrointestinal disturbances sometimes occur.

Hyperreactive individuals may display ephedrine-like reactions such as tachycardia,
palpitations, headache, dizziness or nausea. Sympathomimetics have been associated
with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor,
weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions,
CNS depression, arrhythmias, and cardiovascular collapse with hypotension.

Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally
mild and infrequent. Nausea and vomiting are the most frequently occurring side effects.

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 5g/kg by stomach tube, no toxicity resulted.

In large doses, sympathomimetics may give rise to giddiness, headache, nausea,
vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in
micturition, muscular weakness, and tenseness, anxiety, restlessness, and insomnia.
Many patients can present a toxic psychosis with delusions and hallucinations. Some
may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and
respiratory failure.

Treatment: Treatment of acute overdosage should be based upon treating the patient
for the symptoms of overdosage of pseudoephedrine as follows:

If the amount ingested is considered dangerous or excessive, induce vomiting with
ipecac syrup unless the patient is convulsing, comatose, or has lost the gag reflex, in
which case perform gastric lavage using a large bore tube. If indicated, follow with
activated charcoal and a saline cathartic. 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.

The treatment of overdosage should provide symptomatic and supportive care.

Exall-D Liquid 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 8 teaspoonfuls in 24 hours.
Children 6 to 12 years of age:
1 teaspoonful (5 mL) every 4-6 hours, not to exceed 4 teaspoonfuls in 24 hours.
Children under 6 years of age:
Consult a physician.

How is Exall-D Liquid Supplied

ExallTM-D Liquid is supplied as a colorless, fruit gum flavored liquid in 16 fl oz (473 mL)
bottles, NDC 63717-555-16, and 1/2 fl oz (15 mL) samples, NDC 63717-555-99.

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. (on 473 mL Label)
Supplied in a tight, light-resistant container with a child-resistant cap. (on 15 mL Label)

Rx Only


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

HI256    09/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC 63717-555-16

EXALLTM-D LIQUID

Antitussive / Nasal Decongestant / Expectorant

Each teaspoonful (5mL) for oral administration contains:
Carbetapentane Citrate..... 10 mg
Pseudoephedrine HCl....... 30 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

HL208   09/09


Principal Display Panel and Side Panel for 15 mL Label:


NDC 63717-555-99

EXALLTM-D LIQUID


Antitussive / Nasal Decongestant / Expectorant

Each teaspoonful (5 mL) for oral administration contains:

Carbetapentane Citrate ......... 10 mg
Pseudoephedrine HCl............ 30 mg
Guaifenesin.......................  100 mg

Rx Only

Professional Sample: Not for Sale


Dye Free / Sugar Free / Alcohol Free
1/2 fl oz (15 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 HELP 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.

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           HL213    09/09







EXALL  D
carbetapentane citrate, pseudoephedrine hydrochloride, guaifenesin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63717-555
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
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:63717-555-99 6 BOTTLE (BOTTLE) in 1 TRAY
1 15 mL in 1 BOTTLE
2 NDC:63717-555-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 11/09/2009
Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)
Revised: 11/2009
 
Hawthorn Pharmaceuticals, Inc.

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