J-MAX  - guaifenesin and phenylephrine hydrochloride syrup 
JayMac Pharmaceuticals LLC

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J-MAX Syrup

DESCRIPTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin......................... 200 mg
Phenylephrine Hydrochloride..... 5 mg

Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is
(-)-m-Hydroxy-α-[(methylamino) methyl]benzyl alcohol hydrochloride.

Phenylephrine Hydrochloride Chemical Structure


Guaifenesin is an expectorant. Chemically, it is 1,2-propanediol,3-(2-methoxyphenoxy)-(+/-)-.


Guaifenesin Chemical Structure

CLINICAL PHARMACOLOGY

Phenylephrine hydrochloride is a sympathomimetic amine which acts predominantly by a direct action
on alpha (α) adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on
the beta (β) adrenergic receptors of the heart. Clinically, phenylephrine shrinks swollen mucous
membranes, reduces tissue hyperemia, edema, and nasal congestion; and increases nasal airway
patency. In therapeutic doses the drug causes little, if any, central nervous system (CNS) stimulation.

Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen
phlegm and bronchial secretions. By reducing the viscosity of secretions, Guaifenesin increases the
efficieniency of the cough reflex and of ciliary action in removing accumulated secretions from the
trachea and bronchi. Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly
metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary
metabolite is (α)-(2-methoxyphenoxy) lactic acid.

INDICATIONS AND USAGE

This product is indicated for temporarily relieving symptoms of upper respiratory tract disorders such
as sinusitis and hay fever; as well as for the temporary relief of coughs associated with respiratory
tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when
these conditions are complicated by tenacious mucus and/or mucus plugs and congestion. This
product is effective in a productive as well as a nonproductive cough, but is of particular value in a
dry, nonproductive cough which tends to injure the mucous membrane of the air passages.

CONTRAINDICATIONS

This product is contraindicated in patients with hypersensitivity to Guaifenesin or with
hypersensitivity or idiosyncrasy to sympathomimetic amines which may be manifested by
insomnia, dizziness, weakness, tremor or arrhythmias. Patients known to be hypersensitive
to other sympathomimetic amines may exhibit cross sensitivity with phenylephrine.
Phenylephrine is contraindicated in patients with hypertension or ventricular tachycardia and
should be employed only with extreme caution in elderly patients or in patients with
hyperthyroidism, bradycardia, partial heart block, myocardial disease, or severe arteriosclerosis.
Phenylephrine is contraindicated in patients on monoamine oxidase inhibitor (MAOI) therapy
and for 14 days after stopping MAOI therapy (see Drug Interactions section).

WARNINGS

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.

Hypertensive crisis can occur with concurrent use of phenylephrine and MAO inhibitors (and for
14 days after stopping MAOI therapy), indomethacin, or with beta (β) blockers and methyldopa. 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. Before
prescribing medication to suppress or modify a cough, it is important that the underlying cause of
the cough is identified, that modification of the cough does not increase the risk of clinical or
physiological complications, and that appropriate therapy for the primary disease is instituted.

PRECAUTIONS

Information for Patients: Patient consultation should include the following information regarding proper use of this medication:

Drug Interactions:

Beta (β) adrenergic blockers and MAO inhibitors may potentiate the pressor effect of phenylephrine.
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 phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause
serious cardiac arrhythmias.

Drug/Laboratory Test Interactions:

Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels.
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 the drug should be discontinued
48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No data are available on the long-term potential of Carcinogenesis, Mutagenesis or impairment
of Fertility in animals or humans.

Pregnancy: Pregnancy Category C:

Animal reproduction studies have not been conducted with this drug. It is also not known whether this
drug can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity.
This drug should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Use of this product by nursing mothers is not recommended because of the higher than usual risk
for infant from sympathomimetic amines.

Pediatric Use:

Safety and effectiveness of this drug in children below the age of six have not been established.
Demonstrate safe use of a short-acting sympathomimetic amine before use of a sustained-action
formulation in pediatric patients. Appropriate studies on the relationship of age to the effects of
Guaifenesin have not been performed in the pediatric population. However, no pediatric-specific
problems have been documented to date.

Geriatric Use:

Geriatric patients are more likely to experience adverse reactions to sympathomimetics. Overdosage
in sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and
death. Demonstrate safe use of a short acting sympathomimetic amine before use of a sustained-action
formulation in geriatric patients.

ADVERSE REACTIONS

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. No serious side effects from Guaifenesin have been
reported.

OVERDOSAGE

This product is comprised of pharmacologically different components (phenylephrine and Guaifenesin).
Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. 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 palpitation, tremor, dizziness, vomiting, fear, labored breathing,
headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, hallucinations, and delirium.
Overdosage with Guaifenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin,
when administered by stomach tube to test animals in doses up to 5 gm/kg, produced no signs of toxicity.

Treatment of acute overdosage would probably be based upon treating the patient for the symptoms of
overdosage of phenylephrine as follows: The treatment of overdosage should provide symptomatic and
supportive care. 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.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and over: 5 to 10 mL (1 to 2 teaspoonfuls) every
4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 to 6 hours, not to
exceed 6 teaspoonfuls in 24 hours.
Children 2 to under 6 years of age: 2.5 mL (1/2 teaspoonful) every 4 to 6 hours, not to
exceed 3 teaspoonfuls in 24 hours.
Children under 2 years of age: As directed by a physician.

HOW SUPPLIED

J-Max Syrup is a red, strawberry-cream flavored syrup available in 16 oz. (473 mL) bottles with
NDC 64661-011-16 and in professional sample bottles of 15 mL with NDC 64661-011-15. J-Max
Syrup is gluten free.

Tamper evident by heat seal under cap. Do not use if there is evidence of tampering.

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.


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

Store at controlled room temperature 15o-30oC (59o-86oF).

Rx Only

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

Manufactured for:
JayMac Pharmaceuticals,
Sunset, LA 70584

Rev 02/07

PRODUCT PACKAGING:

The packaging below represents the labeling used:

Principal Display Panel and Side Panels for 15 mL Label:

NDC 64661-011-15

J-MAX
Syrup

Each 5 mL contains:
Guaifenesin............ 200 mg
Phenylephrine HCl.... 5 mg

Rx Only

1/2 fl oz (15 mL)

DOSAGE AND ADMINISTRATION:
Adults and children 12 years of age and over: 5 to 10 mL (1 to 2 teaspoonfuls) every 4 to 6 hours,
not to exceed 12 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful)
every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours. Children 2 to under 6 years of age:
2.5 mL (1/2 teaspoonful) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours. Children under
2 years of age:
As directed by a physician.

Store at controlled room temperature, 15o-30oC (59o-86oF).

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, CONTACT A POISON
CONTROL CENTER AND SEEK
PROFESSIONAL ASSISTANCE IMMEDIATELY.

Manufactured for:

JayMac Pharmaceuticals
Sunset, LA 70584           Rev. 11/07

PROFESSIONAL SAMPLE
NOT FOR RESALE


J-Max Syrup Packaging

J-Max Syrup Packaging


J-MAX 
guaifenesin, and phenylephrine hydrochloride   syrup
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)64661-011
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
164661-011-156 BOTTLE In 1 TRAYcontains a BOTTLE
115 mL In 1 BOTTLEThis package is contained within the TRAY (64661-011-15)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/14/2006

Labeler - JayMac Pharmaceuticals LLC (830767260)
Registrant - Great Southern Laboratories (056139553)
Establishment
NameAddressID/FEIOperations
Great Southern Laboratories056139553manufacture
Revised: 12/2009JayMac Pharmaceuticals LLC