HYDROCODONE BITARTRATE AND ACETAMINOPHEN Solution [Preferred Pharmaceuticals Inc.]

Potential effects of high dosage are also listed in the OVERDOSAGE section.

Cardio-renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension.

Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.

Endocrine: Hypoglycemic coma.

Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting.

Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention.

Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia.

Hypersensitivity: Allergic reactions.

Musculoskeletal: Skeletal muscle flaccidity.

Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression (see OVERDOSAGE), shortness of breath.

Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

Skin: Cold and clammy skin, diaphoresis, pruritus, rash.

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HYDROCODONE BITARTRATE AND ACETAMINOPHEN Solution [Preferred Pharmaceuticals Inc.]