Gentex LQ

RX only

DESCRIPTION
Antitussive / nasal decongestant/ expectorant syrup for oral administration.
Each 5 ml contains:
Carbetapentane
Citrate . . . . . . . . . . . 20 mg
Phenylephrine
Hydrochloride . . . . . 10 mg
Guaifenesin . . . . . . . 100 mg
Inactive ingredients include benzoic acid, bitter masking agent, citric acid, glycerin, edetate disodium, FD&C Red
#40, natural spearmint flavor,#40, natural spearmint flavor, propylene glycol, sodium citrate dihydrate, sorbitol,
sugar, and water.

CLINICAL PHARMACOLOGY
Carbetapentane is a centrally acting, non-narcotic antitussive. Phenylephrine HCl is a sympathomimetic which acts predominantly on alpha receptors and have little action on beta receptors. They therefore function as oral nasal decongestants with minimal CNS stimulation. Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. Sinus and bronchial drainage is improved and dry, nonproductive coughs become more productive and less frequent.

INDICATIONS AND USAGE
For the temporary relief of nonproductive cough accompanying respiratory tract congestion associated with the
common cold, influenza, sinusitis, and bronchitis.

CONTRAINDICATIONS
This product is contraindicated in infants and newborns, and in patients with a known hypersensitivity to any of the
components. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, hyperthyroidism, and in patients on MAO inhibitor therapy. Patient idiosyncrasy to adrenergic agents may be manifested by insomnia, dizziness, weakness, tremor, or arrhythmias.

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

DO NOT EXCEED RECOMMENDED DOSAGE.
PRECAUTIONS
Drug Interactions: MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine, and veratrum alkaloids. Laboratory Tests Interactions: Guaifenesin may produce an increase urinary 5- ydroxyindoleacetic 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 cetechols. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests. Carcinogenesis, Mutagenesis,

Impairment of Fertility: No adequate and well controlled studies have 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.

Geriatric Use: The elderly (60 years or older) may be more susceptible to the vasopressor effects of ympathomimetics. Confusion, hallucinations, seizures, CNS depression, and stroke may be more likely to occur in geriatric patients taking sympathomimetics.

ADVERSE REACTIONS
Mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic
drugs, may occur. Nervousness, excitability, restlessness, dizziness, weakness, and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause light-headedness, nausea, and/or vomiting. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias, and cardiovascular collapse with hypotension.

OVERDOSAGE
Signs and Symptoms: Central effects include restlessness, dizziness, tremor, hyperreactive reflexes, talkativeness, irritability, and Cardiovascular and renal effects include difficulty in urination, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, anorexia, nausea, vomiting, diarrhea, and abdominal cramps.

Recommended Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method; however, vomiting should not be induced in patients with impaired consciousness. 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 administrated as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive.

Manufactured for:
Gentex Pharma
Madison, MS 39110

500276 Iss. 10/2005

.