{"adverse_reactions":["6 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 have been reported with the use of guaifenesin."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 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 efficiency 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 β-(2-methoxphenoxy) lactic acid. Pseudoephedrine, a sympathomimetic amine, acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction. The medication shrinks swollen nasal mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency. Also, drainage of sinus secretions is increased and obstructed eustachian ostia may be opened. Dextromethorphan HBr is an antitussive agent which, unlike the isomeric levorphanol, has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. In therapeutic dosage, dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine."],"contraindications":["4 CONTRAINDICATIONS P-Tuss DM is contraindicated in patients with hypersensitivity to any of its components or idiosyncrasy to sympathomimetic amines which may be manifested by insomnia, dizziness, weakness, tremor, or arrhythmias."],"description":["11 DESCRIPTION Each white, capsule-shaped, scored, P-Tuss DM tablet contains: Dextromethorphan HBr... 30 mg Pseudoephedrine HCl... 60 mg Guaifenesin................ 600 mg It also contains: calcium phosphate diabasic, magnesium stearate, methylcellulose, povidone. Dextromethorphan hydrobromide is an antitussive agent having the chemical name, Morphinan, 3-methoxy-17-methyl, (9α, 13α, 14α)-, hydobromide, monohydrate. It has the following structural formula: Pseudoephedrine Hydrochloride is a nasal decongestant having the chemical name Benzenemethanol, α-[1-(methylamino)ethyl]-, [S-R*, R*)]-, hydrochloride It has the following structural formula: Guaifenesin is an expectorant having the chemical name 1,2 Propanediol, 3-(2 methoxyphenoxy)- and has the following structural formula:"],"dosage_and_administration":["2 DOSAGE & ADMINISTRATION Adults and children over 12 years of age : One or two tablets every 12 hours, not to exceed 4 tablets in 24 hours. Children 6 to 12 years of age : One tablet every 12 hours, not to exceed 2 tablets in 24 hours. Children 2 to 6 years of age : 1/2 tablet every 12 hours, not to exceed one tablet in 24 hours. Not recommended for children under 2 years of age."],"drug_interactions":["7 DRUG INTERACTIONS Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of sympathomimetic amines. 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. 1 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY No data are available on the long-term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans. 1 PREGNANCY Category C: Animal reproduction studies have not been conducted with the components of this product. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, this drug should be given to a pregnant woman only if clearly needed. 3 NURSING MOTHERS Use of this product by nursing mothers is not recommended because of the higher than usual risk to infants from sympathomimetic amines."],"effective_time":"20110121","how_supplied":["16 HOW SUPPLIED Bottles of 100 , white, capsule-shaped, scored tablets imprinted with \"514\" on one side and the Prasco Logo on the other side. NDC 66993-514-02. Store at room temperature between 15°- 30°C (59°-86°F). Dispense in tight containers with a child resistant closures. Rx Only Manufactured for: PRASCO Laboratories Cincinnati, Ohio 45249 By: Sovereign Pharmaceuticals, Ltd. Fort Worth, Texas 76118 PIPRAS-08 Iss. 7/2002"],"id":"2b3ca4a2-8043-41e5-8ad5-8559212b60e0","indications_and_usage":["1 INDICATIONS & USAGE P-Tuss DM Tablets are indicated for the temporary relief of nasal congestion and coughs associated with upper respiratory tract infections and related conditions such as sinusitis, pharyngitis and bronchitis and asthma, particularly when these conditions are complicated by tenacious mucus and/or mucous plugs and congestion. P-Tuss DM is effective in productive as well as non-productive cough, but is of particular value in dry, nonproductive cough, which tends to injure the mucous membrane of the air passages."],"openfda":{},"overdosage":["10 OVERDOSAGE 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 grams/kg, produced no signs of toxicity. In severe cases of overdosage, treatment should be aimed at reducing further absorption of the drug. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion. Overdosage with dextromethorphan may produce central nervous system excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single 300 mg dose has been reported. Toxicity with pseudoephedrine may be manifest as excessive CNS stimulation resulting in excitement, tremor, restlessness, and insomnia. Other effects may include tachycardia, hypertension, pallor, mydriasis, hyperglycemia and urinary retention. Severe overdosage my cause tachypnea or hyperpnea, hallucinations, convulsions or delirium, but in some individuals there may be CNS depression with somnolence, stupor or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Adrenergic receptor blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the beta-blocker propanolol which is indicated when there are signs of cardiac toxicity. Theoretically, pseudoephedrine is dialyzable but procedures have not been clinically established. In severe cases of overdosage, it is essential to monitor both the heart (by electrocardioghraph) and plasma electrolytes and to give intravenous potassium as indicated. Vasopressors may be used to treat hypotension. Excessive CNS stimulation may be counteracted with parenteral diazepam. Stimulants should not be used."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2b3ca4a2-figure-01 2b3ca4a2-figure-02 2b3ca4a2-figure-03 2b3ca4a2-figure-04"],"precautions":["PRECAUTIONS Use with caution in patients with diabetes, hypertension, cardiovascular disease. 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. 4 PEDIATRIC USE This product is not recommended for use in children under 2 years of age. 5 GERIATRIC USE The elderly (60 years and older) Are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death."],"set_id":"02e15a08-e6f8-43c3-828a-55454cf3156f","spl_product_data_elements":["P-Tuss DM dextromethorphan hydrobromide, pseudoephedrine hydrochloride, guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE GUAIFENESIN GUAIFENESIN CALCIUM PHOSPHATE MAGNESIUM STEARATE METHYLCELLULOSE (100 CPS) POVIDONE 514;PrascoLogo"],"version":"1"}