DESCRIPTION:

Revised Formula

NDC 58809-536-01



CARBATUSS is an alcohol-free, red liquid for oral administration having a spearmint odor and flavor.



Each teaspoonful (5 mL) contains:

Carbetapentane Citrate..........................20 mg

Phenylephrine Hydrochloride..................10 mg

Guaifenesin........................................100 mg

CLINICAL PHARMACOLOGY:

Carbetapentane Citrate is a centrally acting non-narcotic antitussive. Phenyleprine 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 & USAGE:

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

CONTRAINDICATIONS:

CARBATUSS is contraindicated in infants and newborns, and in patients with 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, diabetes mellitus, 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.

PRECAUTIONS:

Drug Interactions:

MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the hypertensive effects of methyldopa, mecamylamine, reserpine, and veratrum alkaloids, Guaifenesin may produce an increase in urinary 5-hydroxy-indoleacetic 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 this drug should be discontinued 48 hours prior to the collections of urine specimens for such tests.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:

No adequate and well controlled studies have been conducted to determine whether the components of CARBATUSS have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

PREGNANCY:

Pregnancy Category C:

Animal reproduction studies have not been conducted with this product. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can effect 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.

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 lightheadedness, nausea and/or vomiting. Sympathomemitic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, anxiety, restlessness, tremor, weakness, 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, hyperactive reflexes, talkativeness, irritability and insomnia. 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.

TREATMENT:

The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by 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 th stomach may be absorbed by activated charcoal administered as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive.

DOSAGE AND ADMINISTRATION:

CARBATUSS is administered orally as follows:

Adults:

1-2 teaspoonfuls every 4-6 hours or as directed by a physician.

Children 6-12 Years:

1 teaspoonful every 4-6 hours or as directed by a physician.

HOW SUPPLIED:

16 Fluid ounce bottles NDC 58809-536-01 and 15 mL bottles NDC 58809-536-02

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

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

STORE AT CONTROLLED ROOM TEMPERATURE BETWEEN 59° - 86°F (15° - 30°C)

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

Distributed by:

GM Pharmaceuticals, Inc.,

Arlington, TX 76012

Rx Only

Rev. 09/10

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC 58809-536-01

REVISED FORMULA

CARBATUSS

Antitussive / Decongestant / Expectorant

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Carbetapentane Citrate................................20 mg

Phenylephrine Hydrochloride........................10 mg

Guaifenesin..............................................100 mg

Rx Only

ONE PINT (473 mL)

GM PHARMACEUTICALS, INC.

USUAL DOSAGE:

Adults:

1-2 teaspoonfuls every 4-6 hours or as directed by a physician.

Children 6-12 years of age:

1 teaspoonful every 4-6 hours or as directed by a physician.

For full prescribing information see package insert.

DISPENSE:

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

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

STORE AT CONTROLLED ROOM TEMPERATURE

BETWEEN 59° - 86°F (15° - 30°C)

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76012

Rx Only

Rev. 09/10