1 INDICATIONS AND USAGE Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients.

Acetaminophen Injection is indicated for the Management of mild to moderate pain in adult and pediatric patients 2 years and older ( 1 ) Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older ( 1 ) Reduction of fever in adult and pediatric patients ( 1 )

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Hepatic Injury [see Warnings and Precautions (5.1) ] Serious Skin Reactions [see Warnings and Precautions (5.2) ] Allergy and Hypersensitivity [see Warnings and Precautions (5.4) ] The most common adverse reactions (incidence greater than or equal to 5%) in patients treated with Acetaminophen Injection were nausea, vomiting, headache, and insomnia in adult patients; nausea, vomiting, constipation and pruritus in pediatric patients.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B.

Braun Medical Inc.

at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

Adult Population A total of 1,020 adult patients have received Acetaminophen Injection in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses.

Most patients were treated with Acetaminophen Injection 1,000 mg every 6 hours.

A total of 13.1% (n=134) received Acetaminophen Injection 650 mg every 4 hours.

All adverse reactions that occurred in adult patients treated with either Acetaminophen Injection or placebo in repeated dose, placebo-controlled clinical trials at an incidence greater than or equal to 3% and at a greater frequency than placebo are listed in Table 4.

The most common adverse events in adult patients treated with Acetaminophen Injection (incidence greater than or equal to 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.

Table 4.

Treatment-Emergent Adverse Reactions Occurring in greater than or equal to 3% of Acetaminophen Injection-treated Adult Patients and at a Greater Frequency than Placebo in Placebo-Controlled, Repeated Dose Studies * Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of Acetaminophen Injection may mask fever.

System Organ Class – Preferred Term Acetaminophen Injection (N=402) n (%) Placebo (N=379) n (%) Gastrointestinal Disorders Nausea Vomiting 138 (34) 62 (15) 119 (31) 42 (11) General Disorders and Administration Site Conditions Pyrexia* 22 (5) 52 (14) Nervous System Disorders Headache 39 (10) 33 (9) Psychiatric Disorders Insomnia 30 (7) 21 (5) Other Adverse Reactions Observed During Clinical Studies of Acetaminophen Injection in Adults The following additional treatment-emergent adverse reactions were reported by adult subjects treated with Acetaminophen Injection in all clinical trials (n=1,020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525).

Blood and lymphatic system disorders: anemia General disorders and administration site conditions: fatigue, infusion site pain, edema peripheral Investigations: aspartate aminotransferase increased, breath sounds abnormal Metabolism and nutrition disorders: hypokalemia Musculoskeletal and connective tissue disorders: muscle spasms, trismus Psychiatric disorders: anxiety Respiratory, thoracic and mediastinal disorders : dyspnea Vascular disorders: hypertension, hypotension Pediatric Population A total of 483 pediatric patients (72 neonates, 167 infants, 171 children, and 73 adolescents) have received Acetaminophen Injection in active-controlled (n=250) and open-label clinical trials (n=225), including 43.9% (n=212) who received 5 or more doses and 31.2% (n=153) who received more than 10 doses.

Pediatric patients received Acetaminophen Injection doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule.

The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively.

The most common adverse events (incidence greater than or equal to 5%) in pediatric patients treated with Acetaminophen Injection were nausea, vomiting, constipation, and pruritus.

Other Adverse Reactions Observed During Clinical Studies of Acetaminophen Injection in Pediatrics The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with Acetaminophen Injection (n=483) that occurred with an incidence of at least 1%.

Blood and lymphatic system disorders : anemia Gastrointestinal disorders : diarrhea General disorders and administration site conditions : pyrexia, injection site pain Metabolism and nutrition disorders : hypokalemia, hypomagnesemia, hypoalbuminemia, hypophosphatemia Musculoskeletal and connective tissue disorders : muscle spasm Nervous system disorders : headache Psychiatric disorders : agitation Renal and urinary disorders : oliguria Respiratory, thoracic and mediastinal disorders : atelectasis, pleural effusion, pulmonary edema, stridor, wheezing Vascular disorders : hypotension, hypertension