Corzall Plus

Generic Name: carbetapentane citrate, pseudoephedrine hydrochloride and pyrilamine maleate
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.

Corzall Plus LIQUID

Corzall Plus Liquid

Rx Only
Antitussive / Decongestant / Antihistamine

DESCRIPTION
Each teaspoonful (5 mL) for oral administration contains:
Carbetapentane Citrate................................ 20 mg
Pseudoephedrine Hydrochloride................... 30 mg
Pyrilamine Maleate.................................... 7.5 mg

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

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

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 (Benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)-, hydrochloride) is the
hydrochloride of pseudoephedrine, a naturally occurring dextrorotatory stereoisomer of ephedrine. Its structure is
as follows:

Pyrilamine Maleate is an antihistamine having the chemical name 2-[[2-Dimethylamino)ethyl] (p-methoxybenzyl)amino]
pyridine maleate (1:1). Its structural formula is as follows:

Corzall Plus - Clinical Pharmacology

Antitussive, decongestant, and antihistaminic 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.

Pseudoephedrine hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory tract
mucous membranes. While is 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 drug is excreted in the urine.

Pyrilamine maleate is a histamine antagonist, specifically an H1 receptor-blocking agent belonging to the alkylamine
class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Pyrilamine
also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic
response (vasodilatation, increased vascular permeability, increased mucus secretion) of nasal tissue. Pyrilamine is well
absorbed from the gastrointestinal tract, with peak plasma concentration after a single, oral dose of 4 mg reached in 5
hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to
be the main site of metabolic transformation.

Indications and Usage for Corzall Plus


CorzallTM Plus Liquid is indicated for the symptomatic relief of the cough, coryza and nasal congestion associated
with the common cold, sinusitis, allergic rhinitis and other upper respiratory tract conditions. Appropriate therapy
should be provided for the primary disease.

Contraindications

Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated
in patients with severe hypertension, severe coronary heart disease and patients on monoamine oxidase (MAO)
inhibitor therapy. Antihistamines are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic
ulcer, and during an asthma attack.

Warnings

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes,
ischemic heart disease, hyperthyroidism, increased intraocular pressure, or prostatic hypertrophy.
(See CONTRAINDICATIONS). Sympathomimetic amines may produce CNS stimulation with convulsions
or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely
to exhibit adverse reactions.

Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended
doses, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage.

Precautions

General: There are studies which demonstrate that carbetapentane has antitussive activity which may suppress
or modify cough. Before prescribing medication to suppress or modify cough, identify and provide therapy for the
underlying cause of the cough and take caution that modification of cough does not increase the risk of clinical
or physiologic complications.

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular
pressure, diabetes mellitus, and prostatic hypertrophy.

Information for patients:

Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to
antihistamines may experience moderate to severe drowsiness. Patients sensitive to
sympathomimetics may note mild CNS stimulation.

Drug 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.

Antihistamines may enhance the effect of tricyclic antidepressants, barbiturates, alcohol, and other CNS
depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines.

Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids,
methyldopa, and mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors and
beta-adrenergic blockers.

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not been conducted with this product. It is not
known whether this product can cause fetal harm when administered to a pregnant woman or affect
reproductive capacity. Give to pregnant women only if clearly needed.

Nursing Mothers:

It is not known if the drugs in this product are excreted in human milk. Since many drugs may
be excreted into human milk and because of the potential for serious side effects in the nursing
infant, this product should only be given to nursing mothers if clearly needed.

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:

The elderly (60 years and older) are more likely to have adverse reactions to sympathomimetics.
Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS
depression and death.

Adverse Reactions

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

Antihistamines: Sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness,
nausea, anorexia, heartburn, weakness, polyuria, and dysuria, and rarely, excitability in children. Urinary
retention may occur in patients with prostatic hypertrophy.

Sympathomimetic Amines: Convulsions, CNS stimulation, cardiac arrhythmia, respiratory difficulties,
increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, pallor and dysuria.

Overdosage

The signs, symptoms and treatment described below are those of H1 antihistamine, pseudoephedrine
and carbetapentane.

Symptoms: Should antihistamine effects predominate, central action constitutes the greatest danger.
In the small child, predominate symptoms are excitation, hallucination, ataxia, incoordination, tremors,
flushed face and fever. Convulsions, fixed and dilated pupils, coma, and death may occur in severe
cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal
depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed;
blood pressure is usually stable.

Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor,
hyperactive reflexes, talkativeness, irritability, and insomnia. Cardiovascular and renal effects include
difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmia, hypertension with subsequent
hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia,
nausea, vomiting, diarrhea and abdominal cramps.

Treatments:
a) Evacuate stomach as condition warrants. Activated charcoal may be useful.
b) Maintain a non-stimulating environment.
c) Monitor cardiovascular status.
d) Do not give stimulants.
e) Reduce fever with sponging.
f) Use sedatives or anticonvulsants to control CNS excitation, and convulsions.
g) Physostigmine may reverse anti-cholinergic symptoms.
h) Ammonium Chloride may acidify the urine to increase urinary excretion of pseudoepehdrine.
i) Further care is symptomatic and supportive.

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:
1/2 to 1 teaspoonful (2.5-5 mL) every 4-6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.
Children under 6 years of age:
Consult a physician.

*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.

How is Corzall Plus Supplied

CorzallTM Plus Liquid is supplied as a clear, fruit gum flavored liquid available in 16 fl oz bottles,
NDC 63717-553-16 and 1/2 fl oz (15 mL) sample bottles, NDC 63717-553-99.

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]

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

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

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

HI 254  08/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used.

NDC 63717-553-16

CORZALLTM PLUS LIQUID

Antitussive / Decongestant / Antihistamine

Each teaspoonful (5 mL) for oral administration contains:
Carbetapentane Citrate.......... 20 mg
Pseudoephedrine HCl............ 30 mg
Pyrilamine Maleate............... 7.5 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, SEE PROFESSIONAL ASSISTANCE OR CONTACT A
POISION 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

HL207  08/09

CORZALL  PLUS LIQUID
carbetapentane citrate, pseudoephedrine, and pyrilamine maleate liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63717-553
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbetapentane Citrate (Carbetapentane) Carbetapentane Citrate 20 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Pyrilamine Maleate (Pyrilamine) Pyrilamine Maleate 7.5 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:63717-553-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 08/28/2009
Labeler - Hawthorn Pharmaceuticals, Inc. (118049704)
Revised: 09/2009
 
Hawthorn Pharmaceuticals, Inc.

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