ACETAMINOPHEN 10 mg/mL Injection, Solution
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Acetaminophen injection is used to relieve mild to moderate pain and to reduce fever. Acetaminophen injection is also used in combination with opioid (narcotic) medications to relieve moderate to severe pain. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Read the full MedlinePlus article ↗- Acetaminophen is a pain reliever and fever reducer. You can use it for everyday aches like headaches, backaches, sore muscles, toothaches, minor arthritis pain, cold-related discom...
- What is acetaminophen actually used for?
- That's a smart thing to think about. The biggest danger with acetaminophen is taking more than the maximum daily dose allowed on your product label — especially if you're also taki...
- How much is too much? I'm worried about taking it too often.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Acetaminophen — tap one for details:
Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII ZT934N0X4W
A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII N762921K75
A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 94255I6E2T
Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0131 | $0.050 / J0131 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Acetaminophen 1000 mg/100mL 00143-9386-10 | Hikma | 100 ml | — | — | FDA listed | — |
| Acetaminophen 10 mg/mL 00264-4100-90 | B. | 100 ml | — | AP2 | FDA listed | — |
| Acetaminophen 10 mg/mL 00781-3156-95 | Sandoz | 10 vials | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 00781-9274-95 | Sandoz | 10 vials | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 24201-0100-24 | Hikma | 24 vials | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 24201-0110-24 | Hikma | 24 vials | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 25021-0705-82 | Sagent | 50 ml | — | AP | FDA listed | — |
| Acetaminophen 10 mg/mL 31722-0205-24 | Camber | 24 vials | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 36000-0306-60 | Baxter | 100 ml | — | — | FDA listed | — |
| Acetaminophen 10 mg/mL 44567-0340-10 | WG | 100 ml | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mLthis 51662-1540-03 | HF | 24 pouches | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 55150-0307-24 | Eugia | 24 vials | — | AP1 | FDA listed | — |
| Acetaminophen 1000 mg/100mL 55579-0110-01 | Solupharm | 24 bottles | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 55579-0405-24 | Solupharm | 24 vials | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 63323-0434-00 | Fresenius | 100 ml | — | — | FDA listed | — |
| Acetaminophen 10 mg/mL 65145-0157-10 | Caplin | 10 pouches | — | AP1 | FDA listed | — |
| Acetaminophen 1000 mg/100mL 67457-0940-10 | Mylan | 100 ml | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 68083-0648-01 | Gland | 100 ml | — | AP | FDA listed | — |
| Acetaminophen 10 mg/mL 70518-4184-02 | REMEDYREPACK | 25 vials | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 72572-0050-10 | Civica, | 10 vials | — | AP1 | FDA listed | — |
| Acetaminophen 10 mg/mL 84549-0100-90 | ProPharma | 100 ml | — | AP2 | FDA listed | — |
| Acetaminophen 10 mg/mL 00264-4050-80 | B. | 50 ml | — | AP2 | FDA listed | — |
| Acetaminophen 10 mg/mL 36000-0372-40 | Baxter | 65 ml | — | — | FDA listed | — |
| Acetaminophen 10 mg/mL 68083-0647-01 | Gland | 50 ml | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 51662-1540-01 | 100 mL in 1 VIAL, SINGLE-DOSE (51662-1540-1) | 2022-04-09 | Active |
| 51662-1540-03 You're viewing this | 24 POUCH in 1 CASE (51662-1540-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1540-2) / 100 mL in 1 VIAL, SINGLE-DOSE | 2022-04-09 | Active |
Pack size FAQ
What quantity is in NDC 51662-1540-03?
What NDC number is used to bill for this package of ACETAMINOPHEN 10 mg/mL Injection, Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
BOXED WARNING (see Warnings and Precautions (5.1)) BOXED WARNING
🎯 Indications and Usage ▾
1 INDICATIONS & 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.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION
2.1General Dosing Information Acetaminophen Injection may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral acetaminophen and Acetaminophen Injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of acetaminophen is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing acetaminophen.
Exceeding the maximum mg/kg daily dose of acetaminophen as described in Tables 1 to 3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of acetaminophen from all routes and from all sources does not exceed the maximum recommended dose.
2.2Recommended Dosage: Adults and Adolescents Adults and adolescents weighing 50 kg and over: the recommended dosage of Acetaminophen Injection is 1,000 mg every 6 hours or 650 mg every 4 hours, with a maximum single-dose of Acetaminophen Injection of 1,000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4,000 mg per day (includes all routes of administration and all acetaminophen-containing products including combination products). Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single-dose of 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 (includes all routes of administration and all acetaminophen-containing products including combination products).
2.3Recommended Dosage: Children Children 2 to 12 years of age: the recommended dosage of Acetaminophen Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single-dose of 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.
2.4Recommended Dosage for Treatment of Fever in Neonates and Infants Neonates, including premature neonates born at ≥ 32 weeks gestational age, up to 28 days chronological age: the recommended dosage of acetaminophen is 12.5 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 50 mg/kg per day, with a minimum dosing interval of 6 hours. Infants 29 days to 2 years of age: the recommended dosage of acetaminophen is 15 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 60 mg/kg per day, with a minimum dosing interval of 6 hours.
2.5Instructions for Intravenous Administration For adult and adolescent patients weighing ≥ 50 kg requiring 1,000 mg doses of Acetaminophen Injection, administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen Injection may be administered without further dilution. Examine the container contents before dose preparation or administering.
DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the vial intravenously over 15 minutes. Use aseptic technique when preparing Acetaminophen Injection for intravenous infusion.
Do not add other medications to the Acetaminophen Injection vial or infusion device. For doses less than 1,000 mg, the appropriate dose must be withdrawn from the 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 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 container of Acetaminophen Injection is not intended for use in patients weighing less than 50 kg. Acetaminop…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTH Acetaminophen Injection is a sterile, clear, colorless solution, free from visible particles, non-pyrogenic, preservative free, isotonic formulation of acetaminophen intended for intravenous infusion. Each 100 mL glass vial contains 1,000 mg acetaminophen (10 mg/mL).
⛔ Contraindications ▾
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)].
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS
5.1Hepatic 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 acetaminophen 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 )].
5.2Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
5.3Risk of Medication Errors Take care when prescribing, preparing, and administering Acetaminophen Injection in order 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 DOSAGE AND ADMINISTRATION (2) ].
5.4Allergy and Hypersensitivity There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention.
Discontinue acetaminophen immediately if symptoms associated with allergy or hypersensitivity occur. Do not use acetaminophen in patients with acetaminophen allergy.
🤒 Adverse Reactions ▾
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) ]
6.1Clinical 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 17.0% (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 4. The most common adverse events in adult patients treated with acetaminophen (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.
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 483 pediatric patients (72 neonates, 167 infants, 171 children, and 73 adolescents) have received acetaminophen 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 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, and pruritus.
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=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 ADVERSE
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Effects of Other Substances on Acetaminophen Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. The clinical consequences of these effects have not been established. Effects of ethanol are complex, because excessive alcohol usage can induce hepatic cytochromes, but ethanol also acts as a competitive inhibitor of the metabolism of acetaminophen.
7.2Anticoagulants Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. As no studies have been performed evaluating the short-term use of acetaminophen in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Published epidemiological studies with oral acetaminophen use during pregnancy have not reported a clear association with acetaminophen use and birth defects, miscarriage, or adverse maternal or fetal outcomes [see Data]. Animal reproduction studies have not been conducted with IV acetaminophen. Reproductive and developmental studies in rats and mice from the published literature identified adverse events at clinically relevant doses with acetaminophen.
Treatment of pregnant rats with doses of acetaminophen approximately equal to the maximum human daily dose (MHDD) showed evidence of fetotoxicity and increases in bone variations in the fetuses. In another study, necrosis was observed in the liver and kidney of both pregnant rats and fetuses at doses approximately equal to the MHDD. In mice and rats treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproductive capacity were reported.
In mice, a reduction in number of litters of the parental mating pair was observed as well as retarded growth, abnormal sperm in their offspring and reduced birth weight in the next generation. In rats, female fertility was decreased following in utero exposure to acetaminophen [see Data]. The estimated background risk of major birth defects and miscarriages for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data The results from a large population-based prospective cohort, including data from 26,424 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.
However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including recall bias. Animal Data 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 1.0% acetaminophen via the diet (357, 715, or 1,430 mg/kg/day).
These doses are approximately 0.43, 0.87, and 1.7 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.
8.2 Lactation Risk Sum…
🆘 Overdosage ▾
10 OVERDOSAGE Signs and Symptoms In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Plasma acetaminophen levels > 300 mcg/mL at 4 hours after oral ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 150 mcg/mL or < 37.5 mcg/mL at 12 hours after ingestion.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post- ingestion. Treatment If an acetaminophen overdose is suspected, obtain a serum acetaminophen assay as soon as possible, but no sooner than 4 hours following oral ingestion.
Obtain liver function studies initially and repeat at 24-hour intervals. Administer the antidote N-acetylcysteine (NAC) as early as possible. As a guide to treatment of acute ingestion, the acetaminophen level can be plotted against time since oral ingestion on a nomogram (Rumack-Matthew).
The lower toxic line on the nomogram is equivalent to 150 mcg/mL at 4 hours and 37.5 mcg/mL at 12 hours. If serum level is above the lower line, administer the entire course of NAC treatment. Withhold NAC therapy if the acetaminophen level is below the lower line.
For additional information, call a poison control center at 1-800-222-1222.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.
12.2Pharmacodynamics 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.
12.3Pharmacokinetics Distribution The pharmacokinetics of acetaminophen have been studied in patients and healthy subjects up to 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. The maximum concentration (Cmax) occurs at the end of the 15 minute intravenous infusion of acetaminophen.
Compared to the same dose of oral acetaminophen, the Cmax 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, Cmax, terminal elimination half-life [T½], systemic clearance [CL], and volume of distribution at steady state [Vss]) following administration of a single intravenous dose of 15 mg/kg in children and adolescents and 1,000 mg in adults are summarized in Table 5. The concentrations of acetaminophen observed in neonates greater than 32 weeks gestational age at birth treated with 12.5 mg/kg dose are similar to infants, children and adolescents treated with a 15 mg/kg dose, and similar to adults treated with a 1,000 mg dose.
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, and oxidation via the cytochrome P450 enzyme pathway, primarily CYP2E1, to form a reactive intermediate metabolite (N-acetyl-p-benzoquinone imine or NAPQI).
With therapeutic doses, NAPQI undergoes rapid conjugation with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates. Acetaminophen metabolites are mainly excreted in the urine. Less than 5% is excreted in the urine as unconjugated (free) acetaminophen and more than 90% of the administered dose is excreted within 24 hours.
CLINICAL P
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE & HANDLING Acetaminophen Injection is a sterile, clear, colorless solution, free from visible particles and is supplied as follows: Acetaminophen Injection is supplied in the following dosage forms. NDC 51662-1540-1 ACETAMINOPHEN INJECTION 1,000mg PER 100mL (10mg/mL) 100mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 1,000 mg per 100 mL (10 mg/mL) 100 mL Single-Dose Vials packaged in a Carton of 24 NDC 55150-307-24 Acetaminophen Injection should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
For single-dose only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.
The vial stopper is not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E.
Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Acetaminophen Injection is a sterile, clear, colorless solution, free from visible particles and is supplied as follows: Acetaminophen Injection is supplied in the following dosage forms. NDC 51662-1540-2 ACETAMINOPHEN INJECTION 1,000mg PER 100mL (10mg/mL) 100mL POUCH HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 1,000 mg per 100 mL (10 mg/mL) 100 mL Single-Dose Vials packaged in a Carton of 24 NDC 55150-307-24 Acetaminophen Injection should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
For single-dose only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.
The vial stopper is not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E.
Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Acetaminophen Injection is a sterile, clear, colorless solution, free from visible particles and is supplied as follows: Acetaminophen Injection is supplied in the following dosage forms. NDC 51662-1540-3 ACETAMINOPHEN INJECTION 1,000mg PER 100mL (10mg/mL) 100mL (CASE OF 24) HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 1,000 mg per 100 mL (10 mg/mL) 100 mL Single-Dose Vials packaged in a Carton of 24 NDC 55150-307-24 Acetaminophen Injection should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
For single-dose only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.
The vial stopper is not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E.
Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India
📋 Description ▾
11 DESCRIPTION Acetaminophen USP is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16.
Its structural formula is: Acetaminophen Injection is a sterile, clear, colorless solution, free from visible particles, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.5 (5.0 to 6.2) and an osmolality of approximately 290 mOsm/kg (280 to 320 mOsm/kg). Each 100 mL contains 1,000 mg acetaminophen, USP, 3,850 mg mannitol, USP, 25 mg cysteine hydrochloride, monohydrate, USP, and 10.4 mg dibasic sodium phosphate, USP. pH is adjusted with hydrochloric acid and/or sodium hydroxide.
STRUCTURE