Acetaminophen 160mg/5ml Liquid
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
Not available
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acetaminophen is a common medicine used to relieve pain and reduce fever. It works by affecting how your brain senses pain and controls body temperature.
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 device that comes with the medication. If no device is provided, ask your pharmacist for a measuring tool to ensure accurate dosing.
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 device that comes with the medication. If no device is provided, ask your pharmacist for a measuring tool to ensure accurate dosing.
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 also contain acetaminophen. Check all labels carefully.
- Avoid or limit alcohol consumption while taking acetaminophen, especially if taking regularly or in high doses, due to increased risk of liver damage.
- Use the provided measuring device (oral syringe or dosing 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:
325 mg to 650 mg every 4 to 6 hours as needed, or 1000 mg every 6 to 8 hours as needed. Max 3000 mg to 4000 mg per 24 hours.
Dose Range:
325 - 1000 mg
Condition-Specific Dosing:
Pain:
325-650 mg every 4-6 hours or 1000 mg every 6-8 hours.
Fever:
325-650 mg every 4-6 hours or 1000 mg every 6-8 hours.
Pediatric Dosing
Neonatal:
Not established (use only under medical supervision, typically 10-15 mg/kg/dose every 6-8 hours for specific indications).
Infant:
10-15 mg/kg/dose every 4-6 hours as needed. Do not exceed 5 doses in 24 hours. Max 75 mg/kg/day (not to exceed 4000 mg/day). For 160mg/5ml liquid, this translates to 5ml per 16kg (approx 35 lbs).
Child:
10-15 mg/kg/dose every 4-6 hours as needed. Do not exceed 5 doses in 24 hours. Max 75 mg/kg/day (not to exceed 4000 mg/day).
Adolescent:
10-15 mg/kg/dose every 4-6 hours as needed. Do not exceed 5 doses in 24 hours. Max 75 mg/kg/day (not to exceed 4000 mg/day). For adolescents over 50 kg, adult dosing may apply.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
CrCl < 30 mL/min: Extend dosing interval to every 6-8 hours.
Dialysis:
Acetaminophen is dialyzable. Administer dose after dialysis.
Hepatic Impairment:
Mild:
Use with caution; consider reduced dose or extended interval.
Moderate:
Use with extreme caution; significantly reduced dose or avoid. Consult physician.
Severe:
Contraindicated in severe active liver disease.
Pharmacology
Mechanism of Action
Acetaminophen (paracetamol) is thought to produce analgesia by inhibiting prostaglandin synthesis primarily in the central nervous system (CNS) and to a lesser extent through a peripheral action by blocking pain impulse generation. It produces antipyresis by acting centrally on the hypothalamic heat-regulating center to produce peripheral vasodilation and sweating, resulting in heat dissipation.
Pharmacokinetics
Absorption:
Bioavailability:
60-90%
Tmax:
0.5-2 hours (oral liquid may be faster)
FoodEffect:
Food may delay Tmax but does not significantly affect the extent of absorption.
Distribution:
Vd:
0.9 L/kg
ProteinBinding:
10-25% (at therapeutic concentrations)
CnssPenetration:
Limited
Elimination:
HalfLife:
1.25-3 hours (prolonged in liver disease or overdose)
Clearance:
Not available
ExcretionRoute:
Renal (as glucuronide and sulfate conjugates)
Unchanged:
<5%
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant or death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product. Serious skin reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis) have been reported.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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. Although many people experience no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
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, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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. Although many people experience no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
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, 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:
- Signs of liver damage: yellowing of skin or eyes (jaundice), dark urine, clay-colored stools, severe nausea or vomiting, loss of appetite, unusual tiredness, pain in the upper right side of the stomach.
- Signs of allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- New or worsening pain or fever.
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 symptoms you experienced as a result of the allergy.
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 (including prescription and over-the-counter drugs, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe for you to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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 symptoms you experienced as a result of the allergy.
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 (including prescription and over-the-counter drugs, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe for you to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all 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 provided by your healthcare provider or the medication label exactly. Do not exceed the maximum daily dose of acetaminophen, which is 4,000 mg (milligrams) per day unless specifically directed to do so by your doctor. Certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe amount of acetaminophen for you to take in a day, consult your doctor or pharmacist. If you accidentally take too much acetaminophen in a day, contact your doctor immediately, even if you feel well.
Before consuming alcohol, discuss the potential risks with your doctor.
Additionally, this medication may interfere with certain laboratory tests. Be sure to inform all 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 your child's doctor before giving them this medication to determine the appropriate dose.
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 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 provided by your healthcare provider or the medication label exactly. Do not exceed the maximum daily dose of acetaminophen, which is 4,000 mg (milligrams) per day unless specifically directed to do so by your doctor. Certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe amount of acetaminophen for you to take in a day, consult your doctor or pharmacist. If you accidentally take too much acetaminophen in a day, contact your doctor immediately, even if you feel well.
Before consuming alcohol, discuss the potential risks with your doctor.
Additionally, this medication may interfere with certain laboratory tests. Be sure to inform all 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 your child's doctor before giving them this medication to determine the appropriate dose.
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 outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Loss of appetite
- Sweating
- Abdominal pain (especially upper right quadrant)
- Extreme tiredness
- Dark urine
- Yellowing of the skin or eyes (jaundice)
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve activated charcoal if caught early, and N-acetylcysteine (NAC) as an antidote.
Drug Interactions
Major Interactions
- Alcohol (increased risk of hepatotoxicity)
- Warfarin (increased INR and bleeding risk with chronic high-dose acetaminophen)
Moderate Interactions
- Isoniazid (increased risk of hepatotoxicity)
- Phenytoin (increased risk of hepatotoxicity, decreased acetaminophen efficacy)
- Carbamazepine (increased risk of hepatotoxicity, decreased acetaminophen efficacy)
- Rifampin (increased risk of hepatotoxicity, decreased acetaminophen efficacy)
- Cholestyramine (decreased acetaminophen absorption)
- Lamotrigine (decreased lamotrigine levels)
Minor Interactions
- Metoclopramide (increased acetaminophen absorption rate)
- Domperidone (increased acetaminophen absorption rate)
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: To establish baseline in patients with pre-existing liver disease or risk factors for hepatotoxicity.
Timing: Prior to initiating chronic or high-dose therapy, or if liver disease is suspected.
Routine Monitoring
Pain/Fever assessment
Frequency: As needed, to assess efficacy.
Target: Reduction in symptoms.
Action Threshold: If symptoms persist or worsen, re-evaluate treatment plan.
Signs/symptoms of liver injury
Frequency: Daily, especially with chronic use or higher doses.
Target: Absence of symptoms.
Action Threshold: If nausea, vomiting, abdominal pain, dark urine, jaundice, or fatigue occur, discontinue and seek medical attention.
Symptom Monitoring
- Pain level
- Body temperature
- Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
- Signs of liver damage (nausea, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice, abdominal pain)
Special Patient Groups
Pregnancy
Acetaminophen is generally considered the analgesic/antipyretic of choice during pregnancy when medically indicated, at recommended doses. However, recent studies suggest a possible association between prolonged high-dose use and certain fetal outcomes (e.g., cryptorchidism, neurodevelopmental issues), though more research is needed. Use the lowest effective dose for the shortest duration.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk at recommended doses.
Second Trimester:
Generally considered low risk at recommended doses.
Third Trimester:
Generally considered low risk at recommended doses. Avoid prolonged high-dose use.
Lactation
Acetaminophen is considered compatible with breastfeeding. It is excreted into breast milk in small amounts, which are generally not considered harmful to a breastfed infant.
Infant Risk:
Low risk (L1)
Pediatric Use
Acetaminophen is widely used and generally safe in pediatric populations when dosed correctly based on weight. Accurate measurement of liquid formulations is crucial to prevent accidental overdose. Always use a dosing syringe or cup, not a household spoon. Do not exceed recommended daily maximums.
Geriatric Use
No specific dose adjustment is typically required for elderly patients based on age alone. However, geriatric patients may have reduced renal or hepatic function, which could necessitate dose adjustments or increased monitoring for adverse effects, particularly liver toxicity.
Clinical Information
Clinical Pearls
- Acetaminophen is the most common cause of acute liver failure in the United States, primarily due to accidental overdose from taking multiple acetaminophen-containing products or exceeding the maximum daily dose.
- Always advise patients to check labels of all other medications (e.g., cold/flu remedies, combination pain relievers) to avoid exceeding the maximum daily dose of acetaminophen.
- For pediatric dosing, emphasize the importance of weight-based dosing and using the correct measuring device (e.g., oral syringe) to ensure accuracy and prevent overdose.
- Educate patients on the signs and symptoms of liver toxicity and the importance of seeking immediate medical attention if an overdose is suspected.
Alternative Therapies
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs) such as ibuprofen, naproxen, or aspirin (for pain and fever).
- Topical analgesics (e.g., lidocaine patches, capsaicin cream) for localized pain.
- Non-pharmacological interventions for pain (e.g., heat/cold therapy, rest, physical therapy) and fever (e.g., cool compresses, light clothing).
Cost & Coverage
Average Cost:
Typically $5 - $20 per 120-240 ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Preferred Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.