FDA label 617f973e-da99-20dd-e053-2a91aa0a32b2

Anaphylactoid Reactions: As with other NSAID-containing products, anaphylactoid reactions may occur in patients without known prior exposure to hydrocodone bitartrate and ibuprofen tablets. Hydrocodone bitartrate and ibuprofen tablets should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Fatal reactions to NSAIDs have been reported in such patients (see CONTRAINDICATIONS and PRECAUTIONS - Pre-existing Asthma ). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions: Products containing NSAIDs, including hydrocodone bitartrate and ibuprofen tablets, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy: As with other NSAID-containing products, hydrocodone bitartrate and ibuprofen tablets should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.

ADVERSE REACTIONS Hydrocodone bitartrate and ibuprofen tablets were administered to approximately 300 pain patients in a safety study that employed dosages and a duration of treatment sufficient to encompass the recommended usage (see DOSAGE AND ADMINISTRATION ). Adverse event rates generally increased with increasing daily dose. The event rates reported below are from approximately 150 patients who were in a group that received one tablet of hydrocodone bitartrate and ibuprofen an average of three to four times daily. The overall incidence rates of adverse experiences in the trials were fairly similar for this patient group and those who received the comparison treatment, acetaminophen 600 mg with codeine 60 mg. The following lists adverse events that occurred with an incidence of 1% or greater in clinical trials of hydrocodone bitartrate and ibuprofen tablets, without regard to the causal relationship of the events to the drug. To distinguish different rates of occurrence in clinical studies, the adverse events are listed as follows: name of adverse event = less than 3% adverse events marked with an asterisk * = 3% to 9% adverse event rates over 9% are in parentheses. Body as a Whole: Abdominal pain*; Asthenia*; Fever; Flu syndrome; Headache (27%); Infection*; Pain. Cardiovascular: Palpitations; Vasodilation. Central Nervous System: Anxiety*; Confusion; Dizziness (14%); Hypertonia; Insomnia*; Nervousness*; Paresthesia; Somnolence (22%); Thinking abnormalities. Digestive: Anorexia; Constipation (22%); Diarrhea*; Dry mouth*; Dyspepsia (12%); Flatulence*; Gastritis; Melena; Mouth ulcers; Nausea (21%); Thirst; Vomiting*. Metabolic and Nutritional Disorders: Edema*. Respiratory: Dyspnea; Hiccups; Pharyngitis; Rhinitis. Skin and Appendages: Pruritus*; Sweating*. Special Senses: Tinnitus. Urogenital: Urinary frequency. Incidence less than 1% Body as a Whole: Allergic reaction. Cardiovascular: Arrhythmia; Hypotension; Tachycardia. Central Nervous System: Agitation; Abnormal dreams; Decreased libido; Depression; Euphoria; Mood changes; Neuralgia; Slurred speech; Tremor, Vertigo. Digestive: Chalky stool; "Clenching teeth"; Dysphagia; Esophageal spasm; Esophagitis; Gastroenteritis; Glossitis; Liver enzyme elevation. Metabolic and Nutritional: Weight decrease. Musculoskeletal: Arthralgia; Myalgia. Respiratory: Asthma; Bronchitis; Hoarseness; Increased cough; Pulmonary congestion; Pneumonia; Shallow breathing; Sinusitis. Skin and Appendages: Rash; Urticaria. Special Senses: Altered vision; Bad taste; Dry eyes. Urogenital: Cystitis; Glycosuria; Impotence; Urinary incontinence; Urinary retention.