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DryMax Syrup

Generic Name: chlorpheniramine maleate, methscopolamine nitrate and pseudoephedrine hydrochloride
Dosage Form: syrup

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.

DryMax Syrup

DryMax Syrup

Rx Only

DESCRIPTION: Each teaspoonful (5 mL) for oral administration contains:
Chlorpheniramine Maleate.................................. 4 mg
Methscopolamine Nitrate................................. 1.25 mg
Pseudoephedrine Hydrochloride......................... 30 mg

Inactive ingredients: Purified Water, Citric Acid, Sodium Citrate, Sodium Saccharin, Sucrose, Grape Flavor,
Bitter Mask, FD and C Red #40, FD and C Blue #1, Propylene Glycol, Glycerin.

DryMax Syrup contains ingredients from the following classes: antihistamine, anticholinergic, and nasal
decongestant.

Chlorpheniramine Maleate is an antihistamine with the chemical name 2-Pyridinepropanamine, γ-(4-chlorphenyl)-N,
N-dimethyl-, (Z)-2-butendioate (1:1) 2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine (1:1).

Methscopolamine Nitrate is an anticholinergic belladonna alkaloid derivative with the chemical name: 3-Oxa-9-
azoniatricyclo(3.3.1.02,4)nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9,9-dimethyl-, nitrate. [7(s)-1α, 2β-4β-5α-7β].

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

CLINICAL PHARMACOLOGY:

Chlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulating actions of histamine
on the H1 receptors of the GI tract, uterus, large blood vessels, and bronchial muscle. It also antagonizes the action
of histamine that results in increased capillary permeability and the formation of edema. Chlorpheniramine maleate
is an alkylamine-type antihistamine. This group of antihistamines are among the most active histamine antagonists
and are generally effective in relatively low doses. They thereby prevent, but do not reverse, responses mediated by
histamine alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal mucosa.
These drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use, but
a significant proportion of patients do experience this effect.

Methscopolamine Nitrate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids
that exhibits antisecretory activity. Methscopolamine inhibits the muscarinic actions of acetylcholine on structures
innervated by postganglionic cholinergic nerves: smooth muscle, cardiac muscle, sinoatrial and atrioventricular nodes,
and exocrine glands. In general, the smaller doses of anticholinergics inhibit salivary and bronchial secretions, sweating,
and accommodation; cause dilation of the pupil; and may affect the heart rate.

Pseudoephedrine hydrochloride is an oral sympathomimetic amine that acts as a 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 drug is excreted in the urine.

INDICATIONS:

This product provides relief of the symptoms resulting from irritation of sinus, nasal, and upper respiratory
tract tissue. Pseudoephedrine exerts a vasoconstrictive and decongestive action while chlorpheniramine
maleate decreases the symptoms of watering eyes, post-nasal drip, and sneezing. Methscopolamine nitrate
further augments the antisecretory activity of this product.

CONTRAINDICATIONS:

This product is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients. It is
also contraindicated in women who are pregnant or nursing. This product is contraindicated in children under
six years of age, because this age group is sensitive to the effects of sympathomimetic amines.

It is also contraindicated in newborn or premature infants, because this age group has an increased susceptibility
to the anticholinergic side effects of chlorpheniramine maleate. Geriatric patients may be more sensitive to the
effects of this medication.

Risk-benefit should be considered when the following conditions exist: Acute asthma; Bladder neck obstruction;
Brain damage in children; Cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary
artery disease, and mitral stenosis; Cardiovascular disease; Diabetes mellitus; Down's Syndrome; Esophagitis,
reflux; Narrow angle glaucoma; Acute hemorrhage with unstable cardiovascular status; Hepatic function
impairment; Hernia; Hypertension; Hyperthyroidism; Intestinal atony in the elderly or debilitated patient; Chronic
lung disease; Myasthenia gravis; Autonomic neuropathy; Paralytic ileus; Prostatic hypertrophy; Psychiatric
disorders; Pyloric obstruction; Renal function impairment; Spastic paralysis, in children; Tachycardia; Toxemia
of pregnancy; Ulcerative colitis; Urinary retention, or predisposition to; Uropathy; Xerostomia.

WARNINGS:

This product may cause drowsiness or blurred vision. Patients taking this product should be warned not
to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or
to perform hazardous tasks while taking this drug.

Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease,
diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. The overdosage
of sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with
accompanying hypotension. Do not exceed recommended dosage.

Heat prostration can occur with the use of methscopolamine when the environmental temperature is high.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy
or colostomy; in this instance, use of methscopolamine would be inappropriate and possibly harmful.

PRECAUTIONS: General:

Use Pseudoephedrine with caution in patients with hypoxia, acidosis, or a history of arteriosclerosis,
bradycardia, partial heart block, hypertension, myocardial disease, thrombosis, or ventricular tachycardia.
Antihistamines have an atropine-like action and should be used with caution in patients with a history of
bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism, cardiovascular disease and
hypertension.

Use methscopolamine with caution in patients with hiatal hernia associated with reflux Esophagitis. Use
extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary
heart disease, congestive heart failure, and cardiac arrhythmia.

Information for Patients:

Patient consultation should include the following information regarding proper use of this medication:
  • Do not take more medication than the amount recommended.
  • This medication should be used with caution during exercise or hot weather, overheating may result in heat stroke.
  • Do not drive or operate machinery if drowsiness or dizziness occurs.
  • Do not ingest alcoholic beverages, monoamine oxidase (MAO) inhibitors, or CNS depression-producing medications (hypnotics, sedatives, tranquilizers) while taking this medication.
  • This medication possibly increases sensitivity of eyes to light.
  • Methscopolamine nitrate may cause blurred vision.
  • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose. Do not double doses.
  • This medication should be stored in a tight, light-resistant container at temperatures between 15o-30oC (59o-86oF).
  • Keep all medications out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Caution patients about the signs of potential side effects, especially:
  • Anticholinergic effects - clumsiness or unsteadiness; severe drowsiness; severe dryness of mouth, nose, or throat; flushing or redness of face; shortness of breath or trouble breathing.
  • Blood dyscrasias-sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness.
  • Fast or irregular heartbeat.
  • Psychotic episodes.
  • Tightness in chest.
Note: When anticholinergics are given to patients, especially children, where the environmental temperature is high
there is a risk of a rapid increase in body temperature because of suppression of sweat gland activity. Infants, patients
with Down's syndrome, and children with spastic paralysis or brain damage may show an increased response to
anticholinergics, thus increasing the potential for side effects.

Geriatric or debilitated patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness,
or confusion.

Laboratory Tests:

The following may be especially important in patient monitoring (other tests may be warranted in some patients,
depending on conditions): Blood pressure determination - recommended at frequent intervals during therapy:
Electrocardiogram (ECG) - monitoring may be required: Intraocular pressure determination - recommended at
periodic intervals, as these medications may increase the intraocular pressure.

Drug Interactions:

Do not take this product if you are presently taking, or have taken within the preceding two weeks, a prescription
drug for high blood pressure or depression without first consulting your physician. Absorption of other oral
medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal
motility and delayed gastric emptying.
Combinations containing any or the following medications, depending on the amount present, may also interact
with this product:
  • Alkalizers, such as: calcium and/or magnesium-containing antacids; Carbonic anhydrase inhibitors; citrates; sodium bicarbonate-urinary excretion of anticholinergics may be delayed by alkalization of the urine, thus potentiating methscopolamine's therapeutic and/or side effects.
  • α-adrenergic blocking agents or other medications with α-adrenergic blocking action - prior to administration of α-adrenergics may block the pressor response to pseudoephedrine, possibly resulting in severe hypotension; medications with α-adrenergic blocking action may decrease the pressor effect and shorten the duration of action of pseudoephedrine.
  • Antacids or absorbent antidiarrheals-simultaneous use of these medications may reduce absorption of methscopolamine, resulting in decreased therapeutic effectiveness; doses of these medications should be spaced 2 or 3 hours apart from doses of methscopolamine.
  • Anesthetics, hydrocarbon inhalation - Concurrent use of chloroform, cyclopropane, halothane, or trichloroethylene with pseudoephedrine may increase the risk of severe ventricular arrhythmias because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetic amines; pseudoephedrine should be used with caution and in substantially reduced dosage in patients receiving these anesthetics. Enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetic amines.
  • Anesthetics, parenteral-local - Pseudoephedrine should be used cautiously and in carefully circumscribed quantities, if at all, with local anesthetics for anesthetizing areas with end arteries (such as the finger, toes, or penis) or otherwise compromised blood supply; ischemia leading to gangrene may result.
  • Anticholinergics - Concurrent use with anticholinergic effects; patients should be advised to report occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy.
  • Antidepressants, trycyclic or maprotiline - Concurrent use may potentiate the cardiovascular effects of pseudoephedrine, possible resulting in arrhythmias, tachycardia, or severe hypertension or hyperpyrexia.
  • Antihypertensives, or diuretics used as - Antihypertensive effects may be reduced when these medications are used concurrently with pseudoephedrine; the patient should be carefully monitored to confirm that the desired effect is being obtained.
  • β-adrenergic blocking agents - Therapeutic effects may be inhibited when these medications are used concurrently with pseudoephedrine, especially larger doses; also, β-adrenergic blockage may result in unopposed α-adrenergic activity with a risk of hypertension and excessive bradycardia with possible heart chlorpheniramine, resulting in headache, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyretic crisis. These medications should not be administered during or within 14 days following the administration of MAO inhibitor therapy.  
  • Metoclopramide - Concurrent use of metoclopramide with anticholinergics may antagonize metoclopramide's effects on gastrointestinal motility.
  • Potassium chloride - Concurrent use with anticholinergics may increase the severity of potassium chloride-induced gastrointestinal lesions.
  • Rauwolfia alkaloids - Concurrent use may prolong the direct-acting sympathomimetic amines by preventing the uptake into storage granules.

Laboratory Test Interactions:

Antihistamines may interfere with diagnostic test results for skin tests using allergen extracts.
Anticholinergics may interfere with diagnostic test results for gastric acid secretion by antagonizing the
effect of pantagastrin and histamine, and for radionucleotide gastric emptying studies by delaying gastric
emptying.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No data is available on the long-term potential of the components of this product for Carcinogenesis,
Mutagenesis or Impairment of Fertility in animals or humans.

Pregnancy: Category C:

Reproduction studies have been performed with chlorpheniramine maleate. Studies in rabbits and rats at doses
up to 50 times and 85 times the human dose revealed no evidence of harm to the fetus. There are, however, no
adequate and well-controlled studies in pregnant women. Therefore, it is not known whether these drugs can
cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Animal reproduction studies have not been conducted with pseudoephedrine or methscopolamine. This product
should be given to a pregnant woman only if clearly needed.

Labor and Delivery:

Use of pseudoephedrine during labor may cause fetal anoxia and bradycardia by increasing contractility of the
uterus and decreasing uterine blood flow.

Nursing Mothers:

Small amounts of sympathomimetic amines and antihistamines are excreted in breast milk; use is not
recommended because of the risk of adverse effects, such as unusual excitement or irritability in infants.
Anticholinergics and antihistamines may inhibit lactation.

Pediatric Use:

Use of antihistamines is not recommended in newborn or premature infants because this age group has
an increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased
tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions,
and death. A paradoxical reaction characterized by hyperexcitability may occur in older children taking
antihistamines.

Use is not recommended for children under six years of age. Infants and young children with spastic
paralysis or brain damage since an increased response to anticholinergics are given to children where the
environmental temperature because of the suppression of sweat gland activity. A paradoxical reaction
characterized by hyperexcitability may occur in children taking large doses of anticholinergics.

Appropriate studies with pseudoephedrine have not been performed in the pediatric population.

Geriatric Use:

Confusion, hallucinations, seizures, and CNS depression may be more likely to occur in geriatric patients
taking sympathomimetic amines. Geriatric patients may also be more sensitive to the effects, especially
the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation, hypotension,
hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention
(especially in males), may be more likely to occur in geriatric patients taking antihistamines.

Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness,
or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as
constipation, dryness of the mouth, and urinary retention (especially in males). If these side effects occur
and continue or are severe, medication should probably be discontinued.

Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger
of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, with
the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is
responsible for many functions of the brain, including memory function.

ADVERSE REACTIONS:

The following adverse reactions have been observed with the use of pseudoephedrine, chlorpheniramine
and methscopolamine; Arrhythmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness,
drowsiness, dryness of mouth, hallucinations, hypotension, hypertension, increased sweating, loss of
appetite, paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus,
tingling in hands or feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting.

Note: Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose
and throat are more likely to occur in the elderly. Nightmares, unusual excitement, nervousness, restlessness,
or irritability are more likely to occur in children and the elderly. When anticholinergics are given to patients,
especially children, where the environmental temperature is high, there is risk of a rapid increase in body
temperature.

Drug Abuse and Dependence

Central nervous system stimulants such as pseudoephedrine have been abused. At high doses, subjects
commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased
appetite. Some individuals become anxious, irritable and loquacious. In addition to the marked euphoria, the
user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use,
tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may
follow rapid withdrawal.
Stimulants, such as pseudoephedrine, are banned and tested for by the U.S. Olympic Committee (USOC) and
the National Collegiate Athletic Association (NCAA).

Overdosage

This product is comprised of pharmacologically different components (sympathomimetic amine, antihistamine,
anticholinergic). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual.
Reaction to an overdose of this product may vary from CNS depression to stimulant. A description of symptoms
which are likely to appear after ingestion of an excess of the individual components follows:
  • Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, and hallucinations.
  • Manifestation of antihistamine overdosage may vary from CNS depression to stimulation. Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation is particularly likely in children as are atropine-like signs and symptoms (dry mouth, fixed, dilated pupils, flushing, hypothermia, and gastrointestinal symptoms). In infants and children particularly, antihistamines, in overdosage may produce convulsion and/or death.
  • The signs and symptoms of overdosage of anticholinergics are headache, nausea, vomiting, blurred vision, fixed and dilated pupils, hot dry skin, dizziness, dryness of mouth, difficulty in swallowing and CNS stimulation.
Treatment of acute overdosage would probably be based upon treating the patient for pseudoephedrine toxicity
which may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness, and
insomnia. Other effects may inculde hyperpyrexia, hypertension, mydriasis, hyperglycemia and urinary retention.
Severe hyperkalemia can occur, probably due to a compartmental shift. No organ damage or significant metabolic
derangement is associated with overdosage.

General Treatment: Treatment is symptomatic and supportive with possible utilization of the following:
  • Induction of emesis (syrup of Ipecac recommended); however, precaution against aspiration is necessary, especially in infants and children.
  • Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient is unable to vomit within three hours of ingestion.
  • Saline Cathartics (milk of magnesia) may be used.
  • Vasopressors to treat hypotension; however epinephrine should not be used since it may further lower blood pressure.
  • For excessive hypertensive effect an α-adrenergic blocker, such as phentolamine, may be administered.
  • Hyperpyrexia, especially in children, may require treatment with tepid water sponge bath.
  • Excessive CNS stimulation may be counteracted with parenteral diazepam.
  • Oxygen and intravenous fluids.
  • Precaution against the use of stimulants (analeptic agents) is recommended because they may cause seizures.
  • Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion.

In severe cases of overdosage it is essential to monitor both the heart (by electrocardiograph) and plasma electrolytes,
and to give intravenous potassium as indicated. In the event of progression of the respiration should be instituted and
maintained until effective respiratory action returns.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and older: 1-2 teaspoonfuls (5-10 mL) every 4 to 6 hours, not to
exceed 8 teaspoonfuls in 24 hours.

Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls
in 24 hours.

DryMax Syrup is not recommended for children under 6 years of age.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose
accordingly.

HOW SUPPLIED:

DryMax Syrup is supplied as a purple, grape flavored, alcohol free, gluten free. in 4 fl oz (118 mL)
bottles, NDC 64661-090-04.

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

Pharmacist: Store at controlled room temperature, 15o-30oC (59o-86oF).
Avoid exposure to heat.

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

Manufactured for:
JayMac Pharmaceuticals
Sunset, LA 70584

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

I - 192                   Rev. 12/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 118mL Label:

NDC 64661-090-04

DryMax
Syrup

Each teaspoonful (5 mL) contains:

Chlorpheniramine Maleate........... 4 mg
Methscopolamine Nitrate........ 1.25 mg
Pseudoephedrine HCl................ 30 mg

ANTIHISTAMINE / ANTICHOLINERGIC
NASAL DECONGESTANT

ALCOHOL FREE / GLUTEN FREE

Rx Only

4 fl oz (118 mL)


Side Panel:

DOSAGE AND ADMINISTRATION:
Adults and children 12 years of age and older:
1-2 teaspoonfuls (5-10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to
exceed 4 teaspoonfuls in 24 hours.
DryMax Syrup is not recommended for children under 6 years of age.

STORAGE: Store at controlled room temperature, 15o-30oC (59o-86oF). Avoid exposure to heat.

Supplied in a tight, light-resistant container with a child-resistant cap.

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

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.

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

Manufactured for:
JayMac Pharmaceuticals
Sunset, LA 70584

Rev. 12/09




DRYMAX 
chlorpheniramine maleate, methscopolamine nitrate, pseudoephedrine hydrochloride syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64661-090
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 4 mg  in 5 mL
Methscopolamine Nitrate (Methscopolamine) Methscopolamine Nitrate 1.25 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:64661-090-04 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/18/2010
Labeler - JayMac Pharmaceuticals LLC (830767260)
Registrant - Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories 056139553 manufacture
Revised: 01/2010
 
JayMac Pharmaceuticals LLC



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