{"abuse":["Abuse"],"adverse_reactions":["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, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias and cardiovascular collapse with hypotension."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate and well controlled studies have been conducted to determine whether the components of CARBATAB-12 ® tablets have a potential for carcinogenesis, mutagenesis, or impairment of fertility."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Carbetapentane citrate is a centrally acting non-narcotic antitussive. Phenylephrine HCI is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors. It therefore functions as an oral nasal decongestant 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, non-productive coughs become more productive and less frequent."],"contraindications":["CONTRAINDICATIONS CARBATAB-12® 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"],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each prolonged-release tablet for oral administration contains: Carbetapentane Citrate............................................. 60 mg Phenylephrine Hydrochloride.................................. 15 mg Guaifenesin ........................................................... 600 mg INACTIVE INGREDIENTS: Hydroxypropyl methylcellulose, dibasic calcium phosphate anhydride, hydrogenated cottonseed oil powder, stearic acid, colloidal silicon dioxide, magnesium stearate. Guaifenesin is an expectorant which occurs as a white to slightly gray, crystalline powder, having a bitter taste. It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol. The chemical name is 3-(2-methoxyphenoxy)-1,2-propanediol. Carbetapentane citrate is an antitussive which occurs as a white powder. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol. Phenylephrine is an adrenergic which occurs as white to practically white crystals having a bitter taste. It is soluble in water and in alcohol. The chemical name is (-)m-hydroxy-alpha-[(methylamine) methyl] benzyl alcohol hydrochloride."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: 1 to 2 tablets every 12 hours, not to exceed 4 tablets in 24 hours. Children 6 to 12 years of age: 1/2 to 1 tablet every 12 hours, not to exceed 2 tablets in 24 hours. This product is not recommended for use in children under 6 years of age. SPECIAL ADMINISTRATION INSTRUCTIONS: Take with a large quantity of fluid to insure proper action."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin my 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 this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests."],"drug_interactions":["Interactions Drug Interactions MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, macamylamine, reserpine, and veratrum alkaloids. Drug/Laboratory Test Interactions Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin my 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 this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.","Drug Interactions MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, macamylamine, reserpine, and veratrum alkaloids."],"effective_time":"20110310","general_precautions":["General There are studies which demonstrate that guaifenesin and carbetapentane have antitussive activity which may suppress or modify cough. Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted. Keep out of the reach of children."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED CARBATAB-12 | tablets are white debossed with \"GMP|12\" bisect on one side, and plain on the other side. Available in bottles of 100 tablets. NDC# 58809615-01, samples of 1's NDC# 58809· 615-02 Store at room temperature, 15° . 30° C (59° -86° F). Protect from light and moisture."],"id":"7baa0e77-c693-437e-8ed9-55aaf48342eb","indications_and_usage":["INDICATIONS AND USAGE For temporary relief of non-productive cough accompanying respiratory tract congestion associated with the common cold, influenza, sinusitis, and bronchitis."],"information_for_patients":["Information for Patients"],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers."],"openfda":{},"overdosage":["OVERDOSAGE CARBATAB-12 ® contains pharmacologically different components (guaifenesin, carbetapentane citrate and phenylephrine HCI). 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 individual components follows: 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 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 administered as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 6963 cl"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients below the age of six have not been established. Product not intended for administration for children 6 years of age and under."],"precautions":["PRECAUTIONS General There are studies which demonstrate that guaifenesin and carbetapentane have antitussive activity which may suppress or modify cough. Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted. Keep out of the reach of children. Information for Patients Laboratory Tests Interactions Drug Interactions MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, macamylamine, reserpine, and veratrum alkaloids. Drug/Laboratory Test Interactions Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin my 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 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 to determine whether the components of CARBATAB-12 ® tablets have a potential for carcinogenesis, mutagenesis, or impairment of fertility. Pregnancy Category C: Animal reproduction studies have not been conducted with CARBATAB-12. ® It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Give to pregnant women only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers. Pediatric Use Safety and effectiveness in pediatric patients below the age of six have not been established. Product not intended for administration for children 6 years of age and under. Geriatric Use"],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with CARBATAB-12. ® It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Give to pregnant women only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"7baa0e77-c693-437e-8ed9-55aaf48342eb","spl_product_data_elements":["Carbatab 12 Carbetapentane, Phenylephrine, and Guaifenesin PENTOXYVERINE CITRATE PENTOXYVERINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GUAIFENESIN GUAIFENESIN HYPROMELLOSE 2208 (100 MPA.S) ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYDROGENATED COTTONSEED OIL STEARIC ACID SILICON DIOXIDE MAGNESIUM STEARATE GMP"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS A persistent cough may be a sign of a serious condition. If cough persists more than one week or tends to recur, or is accompanied by fever, rash, or persistent headache, patient reevaluation should should be considered. Use in Pregnancy : Safety for use during pregnancy has not been established. Special Risk Patients: Use with caution in patients with hypertension or ischemic heart disease, and persons over 60 years."]}