{"adverse_reactions":["ADVERSE REACTIONS Adverse reactions include drowsiness, lassitude, nausea, giddiness, constipation, respiratory depression, addiction, blurred vision, cardiac palpitations, flushing, increased irritability or excitement. The most frequently observed adverse reactions include lightheadedness, dizziness, drowsiness, sedation, nausea and vomiting. These effects seem to be more predominate in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Respiratory System: Hydrocodone produces close-related respiratory depression by acting directly on the brain stem respiratory centers. Cardivascular: Hypertension, postural hypotension and palpitations. Genitourinary System: Ureleral spasm, spasm of vesicle 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 patients than in recumbent patients."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The medication shrinks swollen nasal mucus membranes; reduces tissue hyperemia, edema, and nasal decongestion; and increases nasal airway patency. Also, drainage of sinus secretions may be increased and obstructed eustachian ostia may be opened."],"contraindications":["CONTRAINDICATIONS Contraindicated in patients known to be hypersensitive to hydrocodone or pseudoephedrine. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to this product. Hydrocodone is contraindicated in the presence of increased intracranial pressure and whenever ventilatory function is depressed; the depression may be exacerbated. This medication should not be used when diarrhea associated with pseudo membranous colitis caused by cephalosporins, lincomycin (possibly including topical clindamycin), or penicillin exists. Furthermore, this medication should not be used in patients with diarrhea caused by poisoning, until toxic material has been eliminated from the gastrointestinal tract (opioids may slow elimination of the toxic material, thereby worsening and prolonging the diarrhea)."],"description":["DESCRIPTION Antitussive/Nasal Decongestant syrup for oral amdinistration. Each 5 mL contains: Hydrocodone* Bitartrate........................................................................................................................................................................... 3 mg *(Warnings: May be habit forming) Pseudoephedrine Hydrochloride............................................................................................................................................................... 15 mg Hydrocodone bitartrate is an opioid analgesic and antitussive. It occurs as fine white crystals or 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). Pseudoephedrine hydrochloride is a nasal decongestant. Its chemical name is benzenemethanol, α-[1-(methylamino)ethyl]-,[S-(R*,R*)], hydrochloride. Also contains benzoic acid, citric acid, D&C Red # 33, FD&C Blue # 1, grape flavoring (artificial), propylene glycol, saccharin sodium, sorbitol, water."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years and older: 1 to 2 teaspoonfuls. Children 6 to under 12 years of age: 1/2 to 1 teaspoonful. Children 2 to under 5 years of age: 1/2 teaspoonful (maximum of 4 mg/kg/day of pseudoephedrine HCl). These doses may be given every 4 to 6 hours as needed. Not recommended for use in children under 2 years of age."],"effective_time":"20120320","how_supplied":["HOW SUPPLIED Supplied as an purple liquid in gallon jugs (NDC 54868-5488-0). KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN, IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Store at controlled room temperatures 15 - 30 C (59 - 86 F). Dispense in tight, light-resistant containers as defined in USP/NF with a child resistant closure. 400250 Iss.5/04 Manufactured for: Pamlab, LLC Distibuted by: Pan American Laboratories, LLC Covington, LA 70433 Additional barcode labeling by: Physicians Total Care, Inc Tulsa, Oklahoma 74146"],"id":"927c86b9-9f54-42ae-89c1-0e44a2a5df89","indications_and_usage":["INDICATIONS AND USAGE Indicated for the temporary relief of cough and nasal congestion associated with upper respiratory tract infections."],"openfda":{},"overdosage":["OVERDOSAGE Signs and Symptoms: Serious overdosage with this product would likely be characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, 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. Recommeded Treatment: Treatment of acute overdosage would probably be based upon treating the patient for hydrocodone toxicity as follows: Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of patient airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride (preferably administered intravenously) is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opiods, including Hydrocodone. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measure 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":["image of no label available"],"precautions":["PRECAUTIONS General: The hydrocodone in this product may exhibit additive effects with other CNS depressants, including alcohol. Respiratory depression can be a hazard so caution should be used, especially in patients with chronic obstructive pulmonary disease. Special Risk Patients: As with any narcotic analgesic agent, this product should be used with caution in elderly or debilitated patients, those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral structure. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyrodism, increasd intraocular pressure, and prostatic hypertrophy. Information for Patients: Patient consultation should include the following information regarding the proper use of this product: Do not take more medication than the amount recommended. Do not drive or operate heavy machinery if drowsiness or dizziness occurs. Do not ingest alcoholic beverages, monoamine oxidase inhibitors, or other CNS depression-producing medications (hypnotics, sedatives, tranquillizers) while taking this product. If a dose is missed, the medication should be taken as soon as possible unless almost time for the next dose. Do not double the dose. Drug Interactions: Patients receiving other narcotic analgesics, general anesthetics, phenothiazines other tranquillizers, sedative hypnotics or other CNS depressants (including alcohol) concomitantly with hydrocodone may exhibit additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. (See WARNINGS) The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone. The concurrent use of anticholinergics with hydrocodone may produce paralyic ileus. MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics reduce the anti-hypertensive effects of methyldopa, mecamylamine, reserpine, and veratrum alkoloids."],"set_id":"03af48c8-58c9-4ce0-9b8b-d5481ba7da95","spl_product_data_elements":["Pancof HC Hydrocodone Bitartrate and Pseudoephedrine Hydrochloride HYDROCODONE BITARTRATE HYDROCODONE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE BENZOIC ACID CITRIC ACID MONOHYDRATE D&C RED NO. 33 FD&C BLUE NO. 1 PROPYLENE GLYCOL SACCHARIN SODIUM DIHYDRATE SORBITOL WATER GRAPE FLAVORING (ARTIFICIAL)"],"version":"1","warnings":["WARNINGS May be habit forming. Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon requested administration of this product and it should be used with the same degree of caution appropriate to the use of other narcotic drugs (see Drug, Abuse and Dependence section)."]}