Guiatex PE

Each teaspoonful (5 mL) of Guiatex PE™ Syrup contains:

INACTIVE INGREDIENTS

Sodium Benzoate, Citric Acid, Saccharin Sodium, Propylene Glycol, Polyethylene Glycol, Sorbitol Solution, Sucralose, D&C Red No. 33, FD&C Red No. 40, Strawberry Flavor, Purified Water.

Guaifenesin is an expectorant with the chemical name: 1,2-Propanediol, 3-(2-methoxyphenoxy)-,(±)-. Its structure is as follows:

C10H14O4                                                  M.W. 198.22

Phenylephrine Hydrochloride is a decongestant, having the chemical name (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride. Its structure is as follows:

C9H13NO2 • HCl                                             M.W. 203.67

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).

Do not exceed recommended dosage. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. 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.

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 physical or physiological complications, and that appropriate therapy for the primary disease is instituted.

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. Take medication with food, water, or milk to minimize gastric irritation.
• Do not take MAO inhibitors (or for 14 days after stopping MAOI therapy) while taking this medication.
• If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; not doubling doses.
• This medication should be stored in a tight, light-resistant container at temperatures between 15°-30°C (59°-86°F).
• 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.
• Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Drug Interactions

Beta (β) adrenergic blockers and MAO inhibitors (or for 14 days after stopping MAOI therapy) 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

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 affect 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 an infant from sympathomimetic amines.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established. Appropriate studies on the relationship of age to the effects of Guaifenesin have not been performed in the pediatric population.

Geriatric Use

Geriatric patients are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and death.

Guiatex PE™ Syrup is supplied as a sugar free, alcohol free, strawberry flavored liquid, in bottles of 16 fl.oz. (473 mL), NDC 51991-597-16.

WARNING: 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.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

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

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx ONLY

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Manufactured by:
Tri-Med Laboratories, Inc.
Somerset, NJ 08873

Iss. 7/08