{"adverse_reactions":["6 ADVERSE REACTIONS Respiratory System: Hydrocodone causes dose-related respiratory depression by acting directly on brain stem respiratory centers. Cardiovascular System: Hypertension, postural hypotension and palpitations. Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates. Central Nervous System: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes and blurred vision. Gastrointestinal System: Nausea and vomiting occur more frequently in ambulatory than in recumbent patients."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY Clinical trials have proven hydrocodone bitartrate to be an effective antitussive agent which is pharmacologically 2 to 8 times as potent as codeine. At equi-effective doses, its sedative action is greater than codeine. The precise mechanism of action of hydrocodone and other opiates is not known, however, hydrocodone is believed to act by directly depressing the cough center. In excessive doses hydrocodone, like other opium derivatives, can depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system is insignificant. The constipation effects of hydrocodone are much weaker than those of morphine and no stronger than those of codeine. Hydrocodone can produce miosis, euphoria, physical and psychological dependence. At therapeutic antitussive doses, it does exert analgesic effects. Following a 10 mg oral dose of hydrocodone administered to five male human subjects, the mean peak concentration was 23.6 + 5.2 ng/mL. Maximum serum levels were achieved at 1.3 + 0.3 hours and half-life was determined to be 3.8 + 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-á – and 6-â - hydroxymetabolites. Potassium guaiacolsulfonate has been used empirically for many decades as an expectorant."],"contraindications":["4 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to P-Tuss Liquid . Hydrocodone is contraindicated in the presence of an intracranial lesion associated with increased intracranial pressure; and whenever ventilatory function is depressed."],"description":["11 DESCRIPTION Each teaspoonful (5mL) contains: Hydrocodone* Bitartrate ........... 5 mg Potassium Guaiacolsulfonate....... 300 mg Inactive ingredients: artifical cherry flavoring, benzoic acid, citric acid, FD&C Red #40. propylene glycol, saccharin sodium, water. This product contains ingredients of the following therapeutic classes: antitussive and expectorant. Hydrocodone bitartrate is an opioid analgesic and antitussive which occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4, 5α-epoxy-3-methoxy-17-methylmorphinan-6-one-tartrate (1:1) hydrate (2:5). Its structure is as follows: Potassium guaiacolsulfonate is an expectorant. The chemical name is benzenesulfonic acid, hydroxymethoxy -, monopotassium salt, hemihydrate. Its structure is as follows:"],"dosage_and_administration":["2 DOSAGE & ADMINISTRATION Adults and adolescents over 12 years of age: 1 to 1 1/2 teaspoonfuls; Children 6 to 12 years of age: 1/2 to 1 teaspoonful; Children 3 to 6 years of age: 1/4 to 1/2 teaspoonful. These doses may be given four times daily as needed. Not recommended for children under 3 years of age."],"drug_abuse_and_dependence":["9 DRUG ABUSE AND DEPENDENCE Special care should be exercised in prescribing hydrocodone for emotionally unstable patients and for those with a history of drug misuse. Such patients should be closely supervised when longterm therapy is contemplated. P-Tuss Liquid is subject to the Federal Controlled Substances Act (Schedule III). Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics, therefore, P-Tuss Liquid should be prescribed and administered with caution. Physical dependence is the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome. Patients physically dependent on opioids will develop an abstinence syndrome upon abrupt discontinuation of an opioid or following the administration of a narcotic antagonist. The character and severity of the withdrawal symptoms are related to the degree of physical dependence. Manifestation of opioid withdrawal are similar to but milder than that of morphine and include lacrimation, rhinorrhea, yawning, sweating, restlessness, dilated pupils, anorexia, gooseflesh, irritability and tremor. In more severe forms, nausea, vomiting, intestinal spasm and diarrhea, increased heart rate and blood pressure, chills, pains in bones and muscles of the back and extremities may occur. Peak effects will usually be apparent at 48 to 72 hours. Treatment of withdrawal is usually managed by providing sufficient quantities of an opioid to suppress severe withdrawal symptoms and then gradually reducing the dose of opioid over a period of several days."],"drug_interactions":["7 DRUG INTERACTIONS Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative hypnotics or other CNS depressants (including alcohol) concomitantly with hydrocodone may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. 1 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY Carcinogenicity, mutagenicity and reproduction studies have not been conducted with P-Tuss Liquid . 1 PREGNANCY Pregnancy Category C . Animal reproduction studies have not been conducted with P-Tuss Liquid . It is also not known whether P-Tuss Liquid can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. P-Tuss Liquid should be given to a pregnant woman only if clearly needed. NONTERATOGENIC EFFECTS Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1.0 mg/kg q6h, Phenobarbital 2 mg/kg q6h, and paregoric 2 to 4 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosages decreased as tolerated. 3 NURSING MOTHERS It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from P-Tuss Liquid , a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 4 PEDIATRIC USE Children up to 3 years of age may be more susceptible to the effects, especially the respiratory depressant effects, of these medications. Paradoxical excitation is especially likely to occur in pediatric patients receiving opioid analgesics. Therefore, narcotic antitussives are not recommended for use in children under three years of age. Children under three years may be more susceptible to respiratory arrest, coma and death. 5 GERIATRIC USE Geriatric patients may be more susceptible to the effects, especially the respiratory depressant effects, of these medications. Also, geriatric patients are more likely to have prostatic hypertrophy or obstruction and age-related renal function impairment, and are therefore more likely to be adversely affected by opioid-induced urinary retention. In addition, geriatric patients may metabolize or eliminate these medications more slowly than younger adults. Lower doses or longer dosing intervals than those usually recommended for adults may be required, and are usually therapeutically effective, for these patients."],"effective_time":"20110120","how_supplied":["16 HOW SUPPLIED P-Tuss Liquid each teaspoonful (5 mL) of which contains hydrocodone bitartrate 5 mg and potassium guaiacolsulfonate 300 mg, is supplied as a red liquid with a cherry flavor in bottles of 16 oz, NDC 66993-510-57. Dispense in a tight, light-resistant container with a child-resistant closure. Store at controlled room temperature 15° - 30°C (59° - 86°F). Manufactured for: PRASCO LABORATORIES Cincinnati, OH 45249 by: Sovereign Pharmaceuticals, Ltd. Fort Worth, TX 76118 Iss. 3/2002 PIPRAS-07"],"id":"f590bcd0-690a-4f23-a7e1-22a0fa8de50d","indications_and_usage":["1 INDICATIONS & USAGE For the temporary relief of dry, non-productive cough due to colds, per tussis or influenza."],"openfda":{},"overdosage":["10 OVERDOSAGE Signs and Symptoms: Serious overdosage with P-Tuss Liquid is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume. Cheyne-Stokes respiation, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur. Treatment: Primary attention should be given to the establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug. Activated charcoal may be of benefit."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL f590bcd0-figure-01 f590bcd0-figure-02 f590bcd0-figure-03"],"precautions":["PRECAUTIONS 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 physiologic complication, and that appropriate therapy for the primary disease is provided. Usage in Ambulatory Patients : Hydrocodone, like all narcotics, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, and patients should be warned accordingly."],"set_id":"9d82a93d-9dfd-4e8f-b042-5029b1c3413e","spl_product_data_elements":["P-Tuss hydrocodone bitartrate, potassium guaiacolsulfonate HYDROCODONE BITARTRATE HYDROCODONE POTASSIUM GUAIACOLSULFONATE POTASSIUM CATION BENZOIC ACID CITRIC ACID MONOHYDRATE FD&C RED NO. 40 PROPYLENE GLYCOL SACCHARIN SODIUM WATER"],"version":"1","warnings":["WARNINGS May be habit forming. Hydrocodone can produce dependence of the morphine type and therefore has the potential of being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of P-Tuss Liquid and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs (see DRUG ABUSE AND DEPENDENCE). Respiratory Depression: P-Tuss Liquid produces dose-related respiratory depression by directly acting on the brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated. Head injury and Increased Intracranial Pressure: The respiratory depressant properties of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions: The administration of P-Tuss Liquid or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions."]}