FDA label 1ac3e745-9f9b-0f7d-e054-00144ff8d46c

HEPATOTOXICITY Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product.

WARNINGS Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. Hepatotoxicity The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen. Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well. Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. There have been postmarketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Oral Solution for patients with acetaminophen allergy. Hypersensitivity/Anaphylaxis At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Respiratory Depression Infants may have increased sensitivity to the respiratory depressant effects of opioids (see ). If use of Hydrocodone bitartrate and acetaminophen oral solution in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring. PRECAUTIONS , Pediatric Use The respiratory depressant effects 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. Head Injury and Increased Intracranial Pressure The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Acute Abdominal Conditions Hydrocodone bitartrate oral solution contains hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion. Misuse, Abuse and Diversion of Opioids Hydrocodone bitartrate oral solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen oral solution in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see ). DRUG ABUSE AND DEPENDENCE

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Boca Pharmacal, LLC at 1-800-444-4011, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Potential effects of high dosage are also listed in the section. OVERDOSE Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension. Cardio-Renal: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, lightheadedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma. Central Nervous System/Psychiatric: Hypoglycemic coma. Endocrine: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting. Gastrointestinal System: Spasm of vesical sphincters, ureteral spasm, and urinary retention. Genitourinary System: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia. Hematologic: Allergic reactions. Hypersensitivity: Skeletal muscle flaccidity. Musculoskeletal: Acute airway obstruction, apnea, dose-related respiratory depression (see ), shortness of breath. Respiratory Depression: OVERDOSAGE Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Special Senses: Cold and clammy skin, diaphoresis, pruritus, rash. Skin: