FDA label bfa28bfb-d891-484b-b65e-451e6347e6bf

5 WARNINGS AND PRECAUTIONS Dose-related respiratory depression: Use with caution. ( 5.1 ) Drug Dependence: Prescribe with caution that is appropriate to the use of other opioids. ( 5.2 ) Head injury and increased intracranial pressure: Avoid in patients with head injury, intra-cranial lesions, or increased intracranial pressure. ( 5.3 ) Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. ( 5.4 ) Avoid concurrent use of alcohol or other central nervous system depressants. ( 5.4 ) Acute abdominal conditions: Use with caution in patients with acute abdominal conditions. ( 5.5 ) Coexisting conditions: Use with caution in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy or urethral stricture, or asthma. ( 5.10 ) 5.1 Respiratory Depression Hydrocodone bitartrate, one of the active ingredients in hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of hydrocodone bitartrate in adults has been associated with fatal respiratory depression, and the use of hydrocodone bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administering hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution because of the potential for respiratory depression. If respiratory depression occurs, discontinue hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution and use naloxone hydrochloride when indicated to antagonize the effect and other supportive measures as necessary [see Overdosage (10) ]. 5.2 Drug Dependence 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 repeated administration of hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution. Prescribe and administer hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution with the same degree of caution appropriate to the use of other opioid drugs [see Drug Abuse and Dependence (9.2 , 9.3) ] . 5.3 Head Injury and Increased Intracranial Pressure The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution should be avoided in these patients. 5.4 Activities Requiring Mental Alertness Hydrocodone bitartrate and chlorpheniramine maleate, two of the active ingredients in hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution. Concurrent use of hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur. 5.5 Acute Abdominal Conditions Hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution should be used with caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus [see Drug Interactions (7.3) ] . 5.6 Co-administration with Anticholinergics The concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Exercise caution when using hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution in patients taking anticholinergic medications. [see Drug Interactions (7.3) ] . 5.7 Co-administration with MAOIs or Tricyclic Antidepressants Hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy as an increase in blood pressure or hypertensive crisis, may occur. In addition, the use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate, one of the active ingredients in hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution, may increase the effect of either the antidepressant or hydrocodone [ see Contraindications (4) and Drug Interactions (7.2) ]. 5.8 Cardiovascular and Central Nervous System Effects The pseudoephedrine hydrochloride contained in hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution can produce cardiovascular and central nervous system effects in some patients such as insomnia, dizziness, weakness, tremor, or arrhythmias. In addition, central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. Therefore, hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or coronary artery disease. 5.9 Dosing Patients should be advised to measure hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions [see Overdosage (10) ] . Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose. 5.10 Coexisting Conditions Hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma. 5.11 Renal Impairment Hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution should be used with caution in patients with severe renal impairment [see Use in Specific Populations (8.6) ; Pharmacokinetics (12.3) ] . 5.12 Hepatic Impairment Hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution should be used with caution in patients with severe hepatic impairment [see Use in Specific Populations (8.7) ] .

6 ADVERSE REACTIONS Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following: Respiratory depression [see Warnings and Precautions (5.1) and Overdosage (10) ] Drug dependence [see Warnings and Precautions (5.2) ] Increased intracranial pressure [see Warnings and Precautions (5.3) and Overdosage (10) ] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.4) ] Paralytic ileus [see Warnings and Precautions (5.5) ] Use of pseudoephedrine, a sympathomimetic amine, may result in the following: Central nervous system effects such as insomnia, dizziness, weakness, tremor, or convulsions [see Warnings and Precautions (5.8) ] Cardiovascular system effects such as arrhythmias, or increased blood pressure, cardiovascular collapse with accompanying hypotension [see Warnings and Precautions (5.8) ] Use of chlorpheniramine, an antihistamine, may result in: Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.4) ] The most common adverse reactions of hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution include: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, or sleeplessness; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, restlessness, insomnia, irritability, tremor. Other adverse reactions include: Cardiovascular: Fast, or slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitations, shock-like state, syncope. Respiratory: Dryness of the pharynx and respiratory passages, occasional tightness of the chest, laryngismus, wheezing, or troubled breathing. Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, and/or loss of appetite. Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention, dysuria, urinary frequency, urinary hesitancy. Dermatological System: Skin rash, pruritus, erythema, urticaria, excessive perspiration. Endocrine System: Changes in glucose utilization, decreased lactation, early menses, glycosuria, gynecomastia, hypoglycemia, increased appetite, increased libido, pheochromocytoma stimulation. Special Senses: labyrinthitis, tinnitus, vertigo, hypermetropia, lacrimation increased, mydriasis, photophobia. The most common adverse reactions of hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride oral solution include: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, or sleeplessness; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, restlessness, insomnia, irritability, tremor. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .