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( 5.1, 8.7) Revised: 12/2021 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 General Dosing Information 2.2 Recommended Dosage: Adults and Adolescents 2.3 Recommended Dosage: Children 2.4 Recommended Dosage for Treatment of Fever in Neonates and Infants 2.5 Instructions for Intravenous Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hepatic Injury 5.2 Serious Skin Reactions 5.3 Risk of Medication Errors 5.4 Allergy and Hypersensitivity 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 7 DRUG INTERACTIONS 7.1 Effects of Other Substances on Acetaminophen 7.2 Anticoagulants 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Patients with Hepatic Impairment 8.7 Patients with Renal Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Adult Acute Pain 14.2 Adult Fever 14.3 Pediatric Acute Pain and Fever 16 HOW SUPPLIED/STORAGE AND HANDLING *Sections or subsections omitted from the full prescribing information are not listed

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