Acetaminophen Child 160mg/5ml Susp
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 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. 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 is not provided, ask your pharmacist for a suitable device to measure your dose. Before using, shake the medication well.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding refrigeration or 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 is not provided, ask your pharmacist for a suitable device to measure your dose. Before using, shake the medication well.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding refrigeration or 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
- Always read the label carefully and follow dosing instructions exactly, especially for children. Do not give more than the recommended dose.
- Do not give more often than every 4 hours, and do not give more than 5 doses in 24 hours.
- Be careful not to use other medicines that also contain acetaminophen (e.g., cold and flu remedies) to avoid accidental overdose.
- Ensure adequate hydration, especially when treating fever.
- Store at room temperature, away from moisture and heat, and out of reach of 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:
maxDailyDose:
4000 mg (prescription products may have lower max of 3000 mg)
Pediatric Dosing
Neonatal:
Not established (consult physician for infants < 3 months)
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). For 160mg/5ml suspension, this translates to 5ml (160mg) for children weighing 24-35 lbs (11-16 kg). Always refer to product specific dosing chart based on weight/age.
Adolescent:
10-15 mg/kg/dose every 4-6 hours as needed (max 5 doses in 24 hours), or adult dose if weight > 48 kg.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Consider extending dosing interval to every 6-8 hours for CrCl < 30 mL/min
Dialysis:
Acetaminophen is dialyzable; administer dose after dialysis session.
Hepatic Impairment:
Mild:
Use with caution, consider reduced dose or extended interval
Moderate:
Use with caution, consider reduced dose or extended interval (e.g., 50% dose or every 8 hours)
Severe:
Contraindicated or significantly reduced dose (e.g., 25% dose or every 12 hours) with close monitoring. Avoid if possible.
Pharmacology
Mechanism of Action
Acetaminophen's exact mechanism is not fully elucidated but is believed to involve inhibition of prostaglandin synthesis, primarily in the central nervous system (CNS), by inhibiting cyclooxygenase (COX) enzymes, particularly COX-2 and possibly a COX-3 variant. It also may involve activation of descending serotonergic pathways and interaction with the cannabinoid system. Unlike NSAIDs, it has minimal anti-inflammatory effects and does not inhibit platelet aggregation.
Pharmacokinetics
Absorption:
Bioavailability:
60-90% (oral)
Tmax:
0.5-2 hours (oral)
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 (readily crosses blood-brain barrier)
Elimination:
HalfLife:
1.5-3 hours (adults); 2-5 hours (neonates); 1-4 hours (children)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (90-100% of dose excreted in urine as glucuronide and sulfate conjugates, and a small amount of unchanged drug)
Unchanged:
Less than 5%
Pharmacodynamics
OnsetOfAction:
30-60 minutes (oral)
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
Risk of severe liver injury: Acetaminophen has been associated with cases of acute liver failure, sometimes resulting in liver transplant or death. Most 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. Risk of serious skin reactions: Acetaminophen has been associated with serious skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue acetaminophen at the first appearance of skin rash or any other sign of hypersensitivity.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 attention immediately:
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
Most people experience few or no side effects when taking this medication. However, some individuals may encounter mild or moderate side effects. If you experience any of the following symptoms, or if they persist or worsen, contact your doctor for guidance:
Upset stomach or vomiting
Trouble sleeping
Headache
Constipation
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns about side effects, consult 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 attention immediately:
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
Most people experience few or no side effects when taking this medication. However, some individuals may encounter mild or moderate side effects. If you experience any of the following symptoms, or if they persist or worsen, contact your doctor for guidance:
Upset stomach or vomiting
Trouble sleeping
Headache
Constipation
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns about side effects, consult 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 the skin or eyes (jaundice), dark urine, pale stools, severe stomach pain, unusual tiredness, nausea, vomiting, loss of appetite.
- Signs of allergic reaction: rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing.
- Any new or worsening symptoms, or if pain/fever persists for more than a few days (e.g., 3 days for fever, 5-7 days for pain).
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 the safety and efficacy of the medication.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication in combination 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 the safety and efficacy of the medication.
This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication in combination with all your other medications and health conditions.
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, be cautious not to take 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 can vary, but it should not exceed 4,000 milligrams (mg) per day unless specified by your doctor. However, certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the appropriate dose for your specific situation, 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, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this drug.
When administering this medication to children, be aware that different brands may have varying dosage recommendations. Therefore, consult your doctor before giving this medication to a child to ensure the correct dose is used.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to make an informed decision about its use.
To avoid potential liver problems, be cautious not to take 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 can vary, but it should not exceed 4,000 milligrams (mg) per day unless specified by your doctor. However, certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the appropriate dose for your specific situation, 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, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this drug.
When administering this medication to children, be aware that different brands may have varying dosage recommendations. Therefore, consult your doctor before giving this medication to a child to ensure the correct dose is used.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Early symptoms (within 24 hours): Nausea, vomiting, loss of appetite, sweating, stomach pain, extreme tiredness.
- Later symptoms (24-72 hours): Right upper quadrant abdominal pain, dark urine, jaundice (yellowing of skin/eyes), confusion, coma (due to liver failure).
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222 right away, even if there are no symptoms. Treatment may involve activated charcoal (if within 1-2 hours of ingestion) and N-acetylcysteine (NAC), an antidote that helps prevent liver damage.
Drug Interactions
Major Interactions
- Alcohol (chronic heavy use increases risk of hepatotoxicity)
- Warfarin (increased INR and bleeding risk with chronic high-dose acetaminophen)
- Isoniazid (increased risk of hepatotoxicity)
- Other hepatotoxic drugs (e.g., methotrexate, amiodarone, carbamazepine - increased risk of liver injury)
Moderate Interactions
- Cholestyramine (reduces acetaminophen absorption)
- Lamotrigine (may reduce lamotrigine levels)
- Phenytoin, Carbamazepine, Phenobarbital (may increase risk of hepatotoxicity due to enzyme induction)
- Zidovudine (may increase zidovudine levels and toxicity)
Minor Interactions
- Oral contraceptives (may slightly reduce acetaminophen clearance)
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: To establish baseline liver health, especially in patients with pre-existing liver disease or those at risk for hepatotoxicity.
Timing: Prior to initiation of chronic or high-dose therapy, or if liver disease is suspected.
Routine Monitoring
Assessment of pain/fever relief
Frequency: As needed, after each dose
Target: Reduction in symptoms
Action Threshold: Lack of efficacy may indicate need for alternative therapy or re-evaluation of diagnosis.
Signs/symptoms of hepatotoxicity (e.g., nausea, vomiting, abdominal pain, dark urine, jaundice)
Frequency: Daily, especially with chronic or high-dose use
Target: Absence of symptoms
Action Threshold: Presence of symptoms warrants immediate discontinuation and medical evaluation.
Liver function tests (ALT, AST)
Frequency: Periodically (e.g., every 3-6 months) for chronic high-dose use or in patients with risk factors for liver injury.
Target: Within normal limits
Action Threshold: Elevations > 2-3x ULN warrant dose reduction or discontinuation and further investigation.
Symptom Monitoring
- Pain level
- Body temperature
- Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
- Signs of liver damage (yellowing of skin/eyes, dark urine, pale stools, severe stomach pain, unusual tiredness, nausea, vomiting)
Special Patient Groups
Pregnancy
Acetaminophen is generally considered the analgesic and antipyretic of choice during pregnancy when medically indicated, at recommended doses. However, recent studies suggest potential associations with neurodevelopmental outcomes with prolonged or high-dose use, warranting cautious use and the lowest effective dose for the shortest duration.
Trimester-Specific Risks:
First Trimester:
Generally considered safe, no increased risk of major congenital malformations.
Second Trimester:
Generally considered safe.
Third Trimester:
Generally considered safe, no increased risk of adverse fetal effects at term.
Lactation
Acetaminophen is considered compatible with breastfeeding. It is excreted into breast milk in small amounts, which are generally not considered harmful to the infant.
Infant Risk:
Low risk. Monitor infant for sedation or unusual irritability, though these are rare.
Pediatric Use
Dosing is weight-based and critical to prevent overdose. Always use an appropriate measuring device (e.g., oral syringe, dosing cup) and never a household spoon. Ensure parents understand the concentration of the product (e.g., 160mg/5ml) to avoid dosing errors, especially when switching between different formulations or brands. Risk of severe liver injury with overdose is higher in children.
Geriatric Use
No specific dose adjustment is typically required based on age alone. However, elderly patients may have reduced liver or kidney function, increasing the risk of adverse effects. Use with caution in those with pre-existing liver disease or chronic alcohol use. Start with the lowest effective dose and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Acetaminophen is a leading cause of acute liver failure in the US, primarily due to accidental overdose from taking too much or taking multiple products containing acetaminophen.
- Always verify the concentration of liquid acetaminophen products (e.g., 160mg/5ml, 80mg/ml drops) to prevent dosing errors, especially in children.
- Educate patients to check all OTC and prescription medications for acetaminophen (often abbreviated as 'APAP' or 'acetam') to avoid exceeding the maximum daily dose.
- N-acetylcysteine (NAC) is the antidote for acetaminophen overdose and is most effective when administered within 8 hours of ingestion.
- While generally safe in pregnancy and lactation, the principle of 'lowest effective dose for the shortest duration' should always apply.
Alternative Therapies
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs) like Ibuprofen (for pain and fever, also has anti-inflammatory effects)
- Naproxen (for pain and fever, also has anti-inflammatory effects, longer duration)
- Aspirin (for pain and fever, but generally avoided in children due to Reye's Syndrome risk)
Cost & Coverage
Average Cost:
Highly variable, typically low cost per 160mg/5ml suspension bottle
Generic Available:
Yes
Insurance Coverage:
Often OTC, not typically covered by prescription plans unless prescribed for specific conditions or through certain Medicaid programs. Some FSA/HSA eligible.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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.