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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use products including combination products) may result in hepatic injury,including the risk of liver failure and death. (5.1) Acetaminophen Injection safely and effectively. See full prescribing information for Acetaminophen Injection. • Do not exceed the maximum recommended daily dose of acetaminophen(by all routes of administration and all acetaminophen-containing Acetaminophen Injection, for intravenous use (^) • products including combination products). (5.1)Take care when prescribing, preparing, and administering Initial U.S. Approval: 1951 (^) acetaminophen injection to avoid dosing errors which could result in accidental overdose and death. (5.3) WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY • Use caution when administering acetaminophen in patients with the See full prescribing information for complete boxed warning following conditions: hepatic impairment or active hepatic disease, incases of alcoholism, chronic malnutrition, severe hypovolemia, or severe Take care when prescribing, preparing, and administering Acetaminophen (^) • renal impairment (creatinine clearance ≤ 30 mL/min). (5.1)Discontinue acetaminophen immediately at the first appearance of skin Injection to avoid dosing errors which could result in accidental overdose and death. (5.3) rash and if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. (5.2, 5.4) Acetaminophen Injection contains acetaminophen. Acetaminophen has ------------------------------ADVERSE REACTIONS------------------------------ The most common adverse reactions in patients treated with acetaminophen been associated with cases of acute liver failure, at times resulting in livertransplant and death. Most of the cases of liver injury are associated with (^) were nausea, vomiting, headache, and insomnia in adult patients and nausea, the use of acetaminophen at doses that exceed the recommended maximum vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients.(6.1) daily limits, and often involve more than one acetaminophen-containing product. (5.1)****. ----------------------------INDICATIONS AND USAGE--------------------------- To report SUSPECTED ADVERSE REACTIONS, contactFresenius Kabi USA, LLC, Vigilance & Medical Affairs at 1-800- Acetaminophen injection is indicated for the: • Management of mild to moderate pain. (1) (^) 7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Management of moderate to severe pain with adjunctive opioid analgesics. (1) ------------------------------DRUG INTERACTIONS------------------------------ • Substances that induce or regulate hepatic cytochrome enzyme CYP2E
- Reduction of fever. (1) may alter the metabolism of acetaminophen and increase its hepatotoxicpotential. (7.1) ----------------------DOSAGE AND ADMINISTRATION---------------------- • Acetaminophen injection may be given as a single or repeated dose. (^) • Chronic oral acetaminophen use at a dose of 4,000 mg/day has been (2.1) shown to cause an increase in international normalized ratio (INR) insome patients who have been stabilized on sodium warfarin as an
- Acetaminophen injection should be administered only as a 15 minute intravenous infusion. (2.4) (^) anticoagulant. (7.2) Adults and Adolescents Weighing 50 kg and Over :^ -----------------------USE IN SPECIFIC POPULATIONS----------------------- • Pregnancy: Category C. There are no studies of intravenous
- 1,000 mg every 6 hours or 650 mg every 4 hours to a maximum of4,000 mg per day. Minimum dosing interval of 4 hours. (2.2) acetaminophen in pregnant women. Use only if clearly needed. (8.1) Adults and Adolescents Weighing Under 50 kg: •^ Nursing Mothers: Caution should be exercised when administered to anursing woman. (8.3)
- 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of75 mg/kg per day. Minimum dosing interval of 4 hours. (2.2) • Pediatric Use: The effectiveness of acetaminophen for the treatment of acute pain and fever has not been studied in pediatric patients less than 2 Children: • Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg (^) years of age. The safety and effectiveness of acetaminophen in pediatricpatients older than 2 years is supported by evidence from adequate and every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours. (2.3) well-controlled studies in adults with additional safety andpharmacokinetic data for this age group. (8.4) ---------------------DOSAGE FORMS AND STRENGTHS---------------------^ •^ Geriatric Use: No overall differences in safety or effectiveness wereobserved between geriatric and younger subjects. (8.5)
- • Injection for intravenous infusion.Each 100 mL flexible plastic container has 1,000 mg acetaminophen (10 (^) • Hepatic Impairment: Acetaminophen is contraindicated in patients with mg/mL). (3) severe hepatic impairment or severe active liver disease and should beused with caution in patients with hepatic impairment or active liver disease. (4, 5.1, 8.6) Acetaminophen is contraindicated:^ -------------------------------CONTRAINDICATIONS----------------------------- • In patients with known hypersensitivity to acetaminophen or to any of •^ Renal Impairment: In cases of severe renal impairment, longer dosingintervals and a reduced total daily dose of acetaminophen may be
- the excipients in the IV formulation. (4)In patients with severe hepatic impairment or severe active liver disease.^ warranted. (5.1, 8.7) (4) Revised: 10/ -----------------------WARNINGS AND PRECAUTIONS----------------------- • Administration of acetaminophen in doses higher than recommended (by all routes of administration and from all acetaminophen-containing
FULL PRESCRIBING INFORMATION: CONTENTS* (^6) ADVERSE REACTIONS 5.4 Allergy and Hypersensitivity WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY 1 INDICATIONS AND USAGE (^) 6.1 Clinical Trial Experience 2 DOSAGE AND ADMINISTRATION 7 DRUG INTERACTIONS 7.1 Effects of Other Substances on Acetaminophen 2.12.2 General Dosing InformationRecommended Dosage: Adults and Adolescents (^) 7.2 Anticoagulants 2.32.4 Recommended Dosage: ChildrenInstructions for Intravenous Administration^8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 3 DOSAGE FORMS AND STRENGTHS 8.28.3^ Labor and DeliveryNursing Mothers 45 CONTRAINDICATIONSWARNINGS AND PRECAUTIONS (^) 8.4 Pediatric Use 5.1 Hepatic Injury 8.58.6^ Geriatric UsePatients with Hepatic Impairment 5.25.3 Serious Skin ReactionsRisk of Medication Errors (^) 8.7 Patients with Renal Impairment 1
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1011 OVERDOSAGEDESCRIPTION 16 HOW SUPPLIED/STORAGE AND HANDLING 14.3 Pediatric Acute Pain and Fever 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.212.3 PharmacodynamicsPharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Adult Acute Pain (^) *Sections or subsections omitted from the full prescribing information are notlisted. 14.2 Adult Fever
FULL PRESCRIBING INFORMATION
WARNING: Risk of Medication Errors and Hepatotoxicity Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:
- the dose in milligrams (mg) and milliliters (mL) is not confused;
- the dosing is based on weight for patients under 50 kg;
- infusion pumps are properly programmed; and
- the total daily dose of acetaminophen from all sources does not exceed maximum daily limits [see Warnings and Precautions (5.3)]. Acetaminophen injection contains acetaminophen. 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 the maximum daily limits, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE Acetaminophen injection is indicated for:
- the management of mild to moderate pain
- the management of moderate to severe pain with adjunctive opioid analgesics
- the reduction of fever
2 DOSAGE AND ADMINISTRATION 2.1 General Dosing Information Acetaminophen injection, for intravenous use, may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting 2
acetaminophen injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day.
Table 2. Dosing for Children
Age Group
Dose given every 4 hours
Dose given every 6 hours
Maximum single dose
Maximum total daily dose of acetaminophen (by any routes) Children 2 to 12 years of age 12.5 mg/kg^ 15 mg/kg^
15 mg/kg (up to 750 mg)
75 mg/kg in 24 hours (up to 3,750 mg)
2.4 Instructions for Intravenous Administration For adult and adolescent patients weighing ≥ 50 kg requiring 1,000 mg doses of acetaminophen injection, acetaminophen injection may be administered without further dilution. Examine the flexible plastic container contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the flexible plastic container intravenously over 15minutes. Use aseptic technique when preparing acetaminophen injection for intravenous infusion. Do not add other medications to the acetaminophen injection flexible plastic container. For doses less than 1,000 mg, the appropriate dose must be withdrawn from the acetaminophen injection flexible plastic container and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed acetaminophen injection flexible plastic container and place the measured dose in a separate empty, sterile container (e.g. glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL flexible plastic container of acetaminophen injection is not intended for use in patients weighing less than 50 kg. Acetaminophen injection is provided in a single-use flexible plastic container and the unused portion must be discarded.
Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump. Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the acetaminophen injection infusion is the primary infusion.
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Once the seal of the flexible plastic container has been penetrated, or the contents transferred to another container, administer the dose of acetaminophen injection within 6 hours. Do not add other medications to the acetaminophen injection solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with acetaminophen injection, therefore do not administer simultaneously.
3 DOSAGE FORMS AND STRENGTHS Acetaminophen injection is a sterile, clear, colorless, non-pyrogenic, preservative free, isotonic formulation of acetaminophen intended for intravenous infusion. Each 100 mL flexible plastic container has 1,000 mg acetaminophen (10 mg/mL).
4 CONTRAINDICATIONS Acetaminophen is contraindicated:
- in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation.
- in patients with severe hepatic impairment or severe active liver disease [see Warnings and Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Hepatic Injury Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death [see Overdosage (10)]. Do not exceed the maximum recommended daily dose of acetaminophen [see Dosage and Administration (2)]. The maximum recommended daily dose of acetaminophen includes all routes of administration and all acetaminophen-containing products administered, including combination products. Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min) [see Use in Specific Populations (8.6, 8.7)].
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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 in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17% (n=173) who received more than 10 doses. Most patients were treated with acetaminophen 1,000 mg every 6 hours. A total of 13.1% (n=134) received acetaminophen 650 mg every 4 hours. All adverse reactions that occurred in adult patients treated with either acetaminophen or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 3. The most common adverse events in adult patients treated with acetaminophen (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.
Table 3. Treatment-Emergent Adverse Reactions Occurring ≥ 3% in Acetaminophen- treated Patients and at a greater frequency than Placebo in Placebo-Controlled, Repeated Dose Studies
System Organ Class - Preferred Term
Acetaminophen (N=402) n (%)
Placebo (N=379) n (%) Gastrointestinal Disorders Nausea Vomiting
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)
- Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of acetaminophen may mask fever.
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Other Adverse Reactions Observed During Clinical Studies of Acetaminophen in Adults The following additional treatment-emergent adverse reactions were reported by adult subjects treated with acetaminophen 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 355 pediatric patients (47 neonates, 64 infants, 171 children, and 73 adolescents) have received acetaminophen in active-controlled (n=250) and open-label clinical trials (n=225), including 59.7% (n=212) who received 5 or more doses and 43.1% (n=153) who received more than 10 doses. Pediatric patients received acetaminophen 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 ≥ 5%) in pediatric patients treated with acetaminophen were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.
Other Adverse Reactions Observed During Clinical Studies of Acetaminophen in Pediatrics The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with acetaminophen (n=355) that occurred with an incidence of at least 1%. Blood and lymphatic system disorders: anemia Cardiac disorders: tachycardia Gastrointestinal disorders: abdominal pain, diarrhea General disorders and administration site conditions: injection site pain, edema peripheral,
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been conducted with IV acetaminophen, and it is not known whether acetaminophen can cause fetal harm when administered to a pregnant woman. Acetaminophen should be given to a pregnant woman only if clearly needed.
The results from a large population-based prospective cohort, including data from 26, women with live born singletons who were exposed to oral acetaminophen during the first trimester, indicate no increased risk for congenital malformations, compared to a control group of unexposed children. The rate of congenital malformations (4.3%) was similar to the rate in the general population. A population-based, case-control study from the National Birth Defects Prevention Study showed that 11,610 children with prenatal exposure to acetaminophen during the first trimester had no increased risk of major birth defects compared to 4,500 children in the control group. Other epidemiological data showed similar results.
While animal reproduction studies have not been conducted with intravenous acetaminophen, studies in pregnant rats that received oral acetaminophen during organogenesis at doses up to 0.85 times the maximum human daily dose (MHDD = 4 grams/day, based on a body surface area comparison) showed evidence of fetotoxicity (reduced fetal weight and length) and a dose-related increase in bone variations (reduced ossification and rudimentary rib changes). Offspring had no evidence of external, visceral, or skeletal malformations. When pregnant rats received oral acetaminophen throughout gestation at doses of 1.2 times the MHDD (based on a body surface area comparison), areas of necrosis occurred in both the liver and kidney of pregnant rats and fetuses. These effects did not occur in animals that received oral acetaminophen at doses 0.3 times the MHDD, based on a body surface area comparison.
In a continuous breeding study, pregnant mice received 0.25, 0.5, or 1% acetaminophen via the diet (357, 715, or 1,430 mg/kg/day). These doses are approximately 0.43, 0.87, and 1. times the MHDD, respectively, based on a body surface area comparison. A dose-related reduction in body weights of fourth and fifth litter offspring of the treated mating pair occurred during lactation and post-weaning at all doses. Animals in the high dose group had a reduced number of litters per mating pair, male offspring with an increased percentage of abnormal sperm, and reduced birth weights in the next generation pups.
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Labor and Delivery There are no adequate and well-controlled studies with acetaminophen during labor and delivery; therefore, it should be used in such settings only after a careful benefit-risk assessment. Nursing Mothers While studies with acetaminophen have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration. Based on data from more than 15 nursing mothers, the calculated infant daily dose of acetaminophen is approximately 1 to 2% of the maternal dose. There is one well-documented report of a rash in a breast-fed infant that resolved when the mother stopped acetaminophen use and recurred when she resumed acetaminophen use. Caution should be exercised when acetaminophen is administered to a nursing woman. Pediatric Use The safety and effectiveness of acetaminophen for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well- controlled studies of acetaminophen in adults. Additional safety and pharmacokinetic data were collected in 355 patients across the full pediatric age strata, from premature neonates (≥ 32 weeks post menstrual age) to adolescents. The effectiveness of acetaminophen for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age [see Dosage and Administration, Recommended Dosage: Children (2.3) and Pharmacokinetics (12.3)]. Geriatric Use Of the total number of subjects in clinical studies of acetaminophen, 15% were age 65 and over, while 5% were age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with Hepatic Impairment Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease [see Warnings and Precautions (5.1), Clinical Pharmacology (12)]. A
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M.W. 151.
Acetaminophen injection, for intravenous use, is a sterile, clear, colorless, non-pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.5 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains acetaminophen, USP, 1,000 mg; mannitol, 3,670 mg and cysteine, 10 mg. pH is adjusted with hydrochloric acid and/or sodium hydroxide.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.
12.2 Pharmacodynamics Acetaminophen has been shown to have analgesic and antipyretic activities in animal and human studies. Single doses of acetaminophen up to 3,000 mg and repeated doses of 1,000 mg every 6 hours for 48 hours have not been shown to cause a significant effect on platelet aggregation. Acetaminophen does not have any immediate or delayed effects on small-vessel hemostasis. Clinical studies of both healthy subjects and patients with hemophilia showed no significant changes in bleeding time after receiving multiple doses of oral acetaminophen.
12.3 Pharmacokinetics Distribution The pharmacokinetics of acetaminophen have been studied in patients and healthy subjects from premature neonates up to adults 60 years old. The pharmacokinetic profile of acetaminophen has been demonstrated to be dose proportional in adults following administration of single doses of 500, 650, and 1,000 mg.
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The maximum concentration (C max) occurs at the end of the 15 minute intravenous infusion of acetaminophen. Compared to the same dose of oral acetaminophen, the C max following administration of acetaminophen is up to 70% higher, while overall exposure (area under the concentration time curve [AUC]) is very similar.
Pharmacokinetic parameters of acetaminophen (AUC, C (^) max, terminal elimination half-life [T1/2], systemic clearance [CL], and volume of distribution at steady state [Vss]) following administration of a single intravenous dose of 15 mg/kg for the pediatric population and 1,000 mg in adults are summarized in Table 4.
Table 4. Acetaminophen Pharmacokinetic Parameters
Subpopulations
Mean (SD) AUC (mcg x h/mL)
Cmax (mcg/mL)
T1/
(h)
CL
(L/h/kg)
Vss (L/kg) Neonates 62 (11)^ 25 (4)^ 7 (2.7)^ 0.12 (0.04)^ 1.1 (0.2) Infants 57 (54) 29 (24) 4.2 (2.9) 0.29 (0.15) 1.1 (0.3) Children 38 (8) 29 (7) 3 (1.5) 0.34 (0.1 0 ) 1.2 (0.3) Adolescents 41 (7)^ 31 (9)^ 2.9 (0.7)^ 0.29 (0.08)^ 1.1 (0.3) Adults 43 (11) 28 (21) 2.4 (0.6) 0.27 (0.08) 0.8 (0.2)
The pharmacokinetic exposure of acetaminophen observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from pharmacokinetic data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a pharmacokinetic exposure similar to that observed in children age 2 years and older.
At therapeutic levels, binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%). Acetaminophen appears to be widely distributed throughout most body tissues except fat.
Metabolism and Excretion Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: Conjugation with glucuronide, conjugation with sulfate,
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parameters in mice consuming up to 1.7 times the MHDD of acetaminophen, based on a body surface area comparison. Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 1.7 times the MHDD (based on a body surface area comparison) and there was a reduction in the number of mating pairs producing a fifth litter at this dose, suggesting the potential for cumulative toxicity with chronic administration of acetaminophen near the upper limit of daily dosing. Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 1.2 times the MHDD and greater (based on a body surface area comparison) result in decreased testicular weights, reduced spermatogenesis, reduced fertility, and reduced implantation sites in females given the same doses. These effects appear to increase with the duration of treatment. The clinical significance of these findings is not known.
14 CLINICAL STUDIES
14.1 Adult Acute Pain The efficacy of acetaminophen in the treatment of acute pain in adults was evaluated in two randomized, double-blind, placebo-controlled clinical trials in patients with postoperative pain. Pain Study 1 evaluated the analgesic efficacy of repeated doses of acetaminophen 1,000 mg vs. placebo every 6 hours for 24 hours in 101 patients with moderate to severe pain following total hip or knee replacement. Acetaminophen was statistically superior to placebo for reduction in pain intensity over 24 hours. There was an attendant decrease in opioid consumption, the clinical benefit of which was not demonstrated. Pain Study 2 evaluated the analgesic efficacy of repeated doses of acetaminophen 1,000 mg every 6 hours or 650 mg every 4 hours for 24 hours versus placebo in the treatment of 244 patients with moderate to severe postoperative pain after abdominal laparoscopic surgery. Patients receiving acetaminophen experienced a statistically significant greater reduction in pain intensity over 24 hours compared to placebo.
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14.2 Adult Fever The efficacy of acetaminophen 1,000 mg in the treatment of adult fever was evaluated in one randomized, double-blind, placebo-controlled clinical trial. The study was a 6-hour, single-dose, endotoxin-induced fever study in 60 healthy adult males. A statistically significant antipyretic effect of acetaminophen was demonstrated through 6 hours in comparison to placebo. The mean temperature over time is shown in Figure 1.
Figure 1: Mean Temperature (ºC) Over Time
14.3 Pediatric Acute Pain and Fever Acetaminophen was studied in 355 pediatric patients in two active-controlled and three open-label safety and pharmacokinetic trials [see Pediatric Use (8.4)].
16 HOW SUPPLIED/STORAGE AND HANDLING Acetaminophen Injection is supplied as follows: Product NDC No. No. Strength Size 434100 63323 - 434 - 00 1,000 mg per 100 mL 100 mL flexible plastic (10 mg per mL) container.
Acetaminophen injection should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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