Acetaminophen 160mg/5ml Solution
WARNING: Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen in it. If you have questions, talk with your doctor. @ COMMON USES: It is used to ease pain and fever.
Drug Class
Analgesic, Antipyretic
Pharmacologic Class
Para-aminophenol derivative
Pregnancy Category
Category B
FDA Approved
Jan 1955
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acetaminophen is a medicine used to relieve pain and reduce fever. It works by affecting how your brain senses pain and controls body temperature. It is not an anti-inflammatory drug like ibuprofen.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If you're using the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one isn't provided, ask your pharmacist for a suitable device to measure your dose.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding refrigeration and freezing. Keep it in its original container, protected from light, with the lid tightly closed. Choose a dry location, such as a closet or drawer, and avoid storing it in a bathroom.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If you're using the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one isn't provided, ask your pharmacist for a suitable device to measure your dose.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding refrigeration and freezing. Keep it in its original container, protected from light, with the lid tightly closed. Choose a dry location, such as a closet or drawer, and avoid storing it in a bathroom.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Do not take more than the recommended dose, as this can cause serious liver damage.
- Do not take with other medicines that contain acetaminophen.
- Avoid or limit alcohol consumption while taking acetaminophen, especially if you have liver problems.
- Always use the provided dosing device (syringe or cup) for liquid formulations to ensure accurate dosing, especially for children.
Available Forms & Alternatives
Available Strengths:
- Acetaminophen 120mg Suppositories
- Acetaminophen 650mg Suppositories
- Acetaminophen 500mg Tablets
- Acetaminophen Child 160mg/5ml Susp
- Acetaminophen 500mg X/s Tablets
- Acetaminophen 500mg E/s Caplets
- Acetaminophen 160mg/5ml Solution
- Acetaminophen 325mg Tablets
- Acetaminophen 10mg/ml Inj, 100ml
- Acetaminophen 160mg/5ml Liquid
- Acetaminophen 500mg E/s Tablets
- Acetaminophen Child 160mg/5ml Susp
- Acetaminophen Infant 160mg/5ml Susp
- Acetaminophen 650mg ER Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
650 mg every 4-6 hours as needed
Dose Range:
325 - 1000 mg
Condition-Specific Dosing:
Max daily dose:
4000 mg (or 3000 mg for chronic use/hepatic risk)
Pediatric Dosing
Neonatal:
Not established (use under strict medical supervision, typically 10-15 mg/kg/dose every 6-8 hours)
Infant:
10-15 mg/kg/dose every 4-6 hours as needed (max 5 doses in 24 hours)
Child:
10-15 mg/kg/dose every 4-6 hours as needed (max 5 doses in 24 hours)
Adolescent:
10-15 mg/kg/dose every 4-6 hours as needed (max 5 doses in 24 hours, not to exceed 4000 mg/day)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
CrCl < 10 mL/min: Administer every 8 hours
Dialysis:
Administer after dialysis; supplemental dose may be needed
Hepatic Impairment:
Mild:
Use with caution; consider reduced dose or extended interval
Moderate:
Avoid or use with extreme caution; consider reduced dose (e.g., 2000 mg/day max) and extended interval
Severe:
Contraindicated in severe active liver disease
Pharmacology
Mechanism of Action
Acetaminophen's exact mechanism is not fully understood but is believed to involve inhibition of prostaglandin synthesis, primarily in the central nervous system (CNS), leading to analgesic and antipyretic effects. It has minimal anti-inflammatory effects due to weak inhibition of cyclooxygenase (COX) in peripheral tissues.
Pharmacokinetics
Absorption:
Bioavailability:
60-90%
Tmax:
0.5-2 hours (oral solution may be faster)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
0.95 L/kg
ProteinBinding:
10-25% (at therapeutic concentrations)
CnssPenetration:
Yes
Elimination:
HalfLife:
1.5-3 hours (prolonged in liver disease or overdose)
Clearance:
Not available
ExcretionRoute:
Renal (90-100% excreted in urine as glucuronide and sulfate conjugates, and a small amount as unchanged drug)
Unchanged:
2-5%
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours, with other drugs containing acetaminophen, or if you have liver disease or drink 3 or more alcoholic drinks every day while using this product. Acetaminophen may also cause severe skin reactions such as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), which can be fatal. Discontinue use and seek medical attention if skin rash occurs.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Difficulty urinating or changes in urine output
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Upset stomach or vomiting
Trouble sleeping
Headache
Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Difficulty urinating or changes in urine output
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Upset stomach or vomiting
Trouble sleeping
Headache
Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe stomach pain
- Nausea or vomiting that doesn't go away
- Unusual tiredness or weakness
- Skin rash, blistering, or peeling
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect your ability to take this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any health problems you have, as they may interact with this medication
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect your ability to take this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Any health problems you have, as they may interact with this medication
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To avoid potential liver problems, do not take any other products that contain acetaminophen. Carefully check the labels of all medications and supplements to ensure you are not exceeding the recommended daily dose of acetaminophen.
Follow the dosage instructions precisely, and do not exceed the maximum daily dose of acetaminophen as directed. The recommended daily dose of acetaminophen is not to exceed 4,000 mg (milligrams) per day, unless otherwise specified by your doctor. However, certain individuals, such as those with liver problems or children, may require a lower dose. If you are unsure about the safe dosage for your specific situation, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen in a day, contact your doctor immediately, even if you are not experiencing any symptoms.
Before consuming alcohol, discuss the potential risks with your doctor.
Additionally, this medication may interfere with certain laboratory tests. Be sure to inform all of your healthcare providers and laboratory personnel that you are taking this medication.
When administering this medication to children, note that different brands may have varying dosage recommendations. Consult with your doctor before giving this medication to a child to ensure the correct dosage.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
To avoid potential liver problems, do not take any other products that contain acetaminophen. Carefully check the labels of all medications and supplements to ensure you are not exceeding the recommended daily dose of acetaminophen.
Follow the dosage instructions precisely, and do not exceed the maximum daily dose of acetaminophen as directed. The recommended daily dose of acetaminophen is not to exceed 4,000 mg (milligrams) per day, unless otherwise specified by your doctor. However, certain individuals, such as those with liver problems or children, may require a lower dose. If you are unsure about the safe dosage for your specific situation, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen in a day, contact your doctor immediately, even if you are not experiencing any symptoms.
Before consuming alcohol, discuss the potential risks with your doctor.
Additionally, this medication may interfere with certain laboratory tests. Be sure to inform all of your healthcare providers and laboratory personnel that you are taking this medication.
When administering this medication to children, note that different brands may have varying dosage recommendations. Consult with your doctor before giving this medication to a child to ensure the correct dosage.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Loss of appetite
- Sweating
- Stomach pain
- Extreme tiredness
- Confusion
- Jaundice (yellowing of skin or eyes)
- Dark urine
What to Do:
Seek immediate medical attention or call a Poison Control Center (1-800-222-1222) right away, even if you feel well. Overdose can cause severe, irreversible liver damage.
Drug Interactions
Major Interactions
- Alcohol (chronic heavy use - increased risk of hepatotoxicity)
- Warfarin (increased INR/bleeding risk with chronic high-dose acetaminophen)
- Isoniazid (increased risk of hepatotoxicity)
- Other hepatotoxic drugs (additive risk)
Moderate Interactions
- Cholestyramine (decreased acetaminophen absorption)
- Lamotrigine (decreased lamotrigine levels)
- Phenytoin, Carbamazepine, Phenobarbital (increased acetaminophen metabolism, potentially increased NAPQI formation)
- Zidovudine (increased zidovudine levels, potential for neutropenia)
Minor Interactions
- Oral contraceptives (may slightly decrease acetaminophen levels)
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease or risk factors for hepatotoxicity.
Timing: Prior to initiation in high-risk patients or for chronic high-dose therapy.
Routine Monitoring
Liver function tests (ALT, AST)
Frequency: Periodically, especially with chronic high-dose use or in patients with risk factors for hepatotoxicity.
Target: Within normal limits
Action Threshold: Significant elevation (e.g., >3x ULN) warrants dose reduction or discontinuation and further investigation.
INR (for patients on warfarin)
Frequency: Regularly, especially when starting or stopping acetaminophen or changing dose.
Target: Therapeutic range for warfarin
Action Threshold: INR outside target range requires warfarin dose adjustment.
Symptom Monitoring
- Signs of liver damage (e.g., yellowing of skin/eyes, dark urine, abdominal pain, nausea, vomiting, unusual tiredness)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of overdose (e.g., nausea, vomiting, abdominal pain, sweating, loss of appetite, extreme tiredness)
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy when used at recommended doses. It is often the preferred analgesic/antipyretic during pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects identified.
Second Trimester:
No increased risk of major birth defects identified.
Third Trimester:
No increased risk of major birth defects identified. Some observational studies have suggested a possible association with neurodevelopmental disorders in children exposed prenatally, but these studies have limitations and a causal link has not been established. Current consensus is that it remains safe when used appropriately.
Lactation
Considered compatible with breastfeeding. It is excreted into breast milk in small amounts, but adverse effects on the infant are unlikely.
Infant Risk:
L1 (Safest)
Pediatric Use
Dosing is weight-based (10-15 mg/kg/dose). Accurate measurement is crucial for liquid formulations. Do not exceed 5 doses in 24 hours. Consult a healthcare professional for children under 2 years or for specific dosing guidance.
Geriatric Use
No specific dose adjustment is typically required based on age alone. However, elderly patients may have reduced hepatic or renal function, which could necessitate dose adjustment or increased monitoring. Start with the lowest effective dose and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Acetaminophen is not an NSAID and does not have significant anti-inflammatory effects or risk of GI bleeding/renal impairment associated with NSAIDs.
- The most critical aspect of acetaminophen use is avoiding overdose due to severe hepatotoxicity. Patients must be educated to check all other medications for acetaminophen content.
- For pediatric dosing, always use a calibrated measuring device (oral syringe or dosing cup) and never a household spoon.
- N-acetylcysteine (NAC) is the antidote for acetaminophen overdose and is most effective when administered within 8 hours of ingestion.
Alternative Therapies
- Ibuprofen (NSAID, also antipyretic/analgesic, but with anti-inflammatory properties and different side effect profile)
- Naproxen (NSAID)
- Aspirin (NSAID, antipyretic/analgesic, but not recommended for children/adolescents with viral infections due to Reye's syndrome risk)
Cost & Coverage
Average Cost:
$5 - $20 per 120-240 ml bottle (160mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.