Acetaminophen Infant 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 medicine used to relieve pain and reduce fever. It works by affecting how your brain senses pain and controls body temperature. This infant suspension is specifically formulated for babies and young children.
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 included, ask your pharmacist for a measuring tool. Before using, shake the medication well.
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 dose, skip the missed dose and resume your regular 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 included, ask your pharmacist for a measuring tool. Before using, shake the medication well.
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 dose, skip the missed dose and resume your regular 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 give more than the recommended dose.
- Do not give more frequently than every 4-6 hours.
- Do not give more than 5 doses in 24 hours.
- Always use the dosing device (syringe or cup) provided with the product to ensure accurate dosing.
- Check all other medicines your child is taking to ensure they do not also contain acetaminophen to avoid accidental overdose.
- Store 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:
Maximum daily dose:
4000 mg (4g) in 24 hours for self-medication; 3000 mg (3g) for chronic use or under medical supervision.
Pediatric Dosing
Neonatal:
Not established (use only under medical supervision for infants < 3 months)
Infant:
10-15 mg/kg per dose every 4-6 hours as needed. Do not exceed 5 doses in 24 hours. For 160mg/5ml suspension: 2.5 ml (40 mg) for 6-11 lbs (0-3 months), 5 ml (80 mg) for 12-17 lbs (4-11 months), 7.5 ml (120 mg) for 18-23 lbs (12-23 months). Always use dosing syringe/cup provided.
Child:
10-15 mg/kg per 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 per 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.
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 or extended interval
Severe:
Contraindicated in severe hepatic impairment or 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.
Pharmacokinetics
Absorption:
Bioavailability:
60-90%
Tmax:
0.5-2 hours (oral)
FoodEffect:
May delay absorption but does not affect extent of absorption
Distribution:
Vd:
0.95 L/kg
ProteinBinding:
10-25% (at therapeutic concentrations)
CnssPenetration:
Yes
Elimination:
HalfLife:
1.25-3 hours (adults); 2-5 hours (neonates/infants)
Clearance:
Not available
ExcretionRoute:
Renal (90-100% as metabolites)
Unchanged:
Less than 5%
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
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
As with any medication, you may experience side effects. While many people have 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 do not go away, 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
As with any medication, you may experience side effects. While many people have 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 do not go away, 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 allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- New or worsening symptoms of pain or fever
- Symptoms of liver damage (yellowing of skin or eyes, dark urine, severe stomach pain, unusual tiredness)
- Any unusual or severe side effects
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 medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins
* Any health problems you have or have had in the past
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. Your doctor and pharmacist will work together to ensure that you can take this medication safely and effectively.
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 medications, health conditions, and concerns with your doctor. This includes:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins
* Any health problems you have or have had in the past
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. Your doctor and pharmacist will work together to ensure that you can take this medication safely and effectively.
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 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 safe dosage 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, be aware that this medication may affect the results of certain laboratory tests. Therefore, 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 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, inform your doctor. It is crucial to discuss the potential benefits and risks of taking this medication during these situations to ensure the best outcome for both 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 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 safe dosage 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, be aware that this medication may affect the results of certain laboratory tests. Therefore, 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 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, inform your doctor. It is crucial to discuss the potential benefits and risks of taking this medication during these situations to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Sweating
- Extreme tiredness
- Loss of appetite
- Abdominal pain (especially upper right quadrant)
- Jaundice (yellowing of skin/eyes)
- Dark urine
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose can cause severe, irreversible liver damage or death, even if initial symptoms are mild or absent.
Drug Interactions
Major Interactions
- Alcohol (chronic heavy use increases risk of hepatotoxicity)
- Warfarin (increased INR and bleeding risk with chronic high doses of acetaminophen)
- Isoniazid (increased risk of hepatotoxicity)
- Other hepatotoxic drugs (additive risk of liver injury)
Moderate Interactions
- Carbamazepine, Phenobarbital, Phenytoin, Rifampin (inducers of CYP enzymes, may increase NAPQI formation)
- Cholestyramine (reduces acetaminophen absorption if given concurrently)
- Lamotrigine (may reduce lamotrigine levels)
- Zidovudine (may increase zidovudine levels and toxicity)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST)
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 therapy.
Routine Monitoring
Symptoms of liver injury (e.g., nausea, vomiting, abdominal pain, dark urine, jaundice)
Frequency: Continuously (patient/caregiver education)
Target: Absence of symptoms
Action Threshold: Prompt medical evaluation if symptoms occur.
Pain/fever assessment
Frequency: As needed, before each dose
Target: Reduction in symptoms
Action Threshold: If symptoms persist or worsen, re-evaluate diagnosis and treatment.
Symptom Monitoring
- Effectiveness in reducing pain or fever
- Signs of allergic reaction (rash, itching, swelling)
- Signs of liver damage (yellowing of skin/eyes, dark urine, severe stomach pain, unusual tiredness)
- Signs of overdose (nausea, vomiting, sweating, extreme tiredness, loss of appetite, abdominal pain)
Special Patient Groups
Pregnancy
Generally considered the analgesic/antipyretic of choice during pregnancy when medically indicated, at the lowest effective dose for the shortest duration. However, recent studies suggest potential risks with prolonged or high-dose use, so caution is advised.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk, but some studies suggest possible association with neurodevelopmental disorders or reproductive issues with prolonged use.
Second Trimester:
Generally considered low risk.
Third Trimester:
Generally considered low risk, but some studies suggest possible association with neurodevelopmental disorders or reproductive issues with prolonged use.
Lactation
Considered compatible with breastfeeding. It is excreted into breast milk in small amounts, but adverse effects on breastfed infants are not expected.
Infant Risk:
L1 (Safest)
Pediatric Use
Acetaminophen is widely used and generally safe in pediatric populations when dosed correctly by weight. Extreme caution is needed to avoid overdose, especially in infants, due to the risk of hepatotoxicity. Always use the correct concentration (160mg/5ml for infant suspension) and dosing device.
Geriatric Use
Generally safe in elderly patients. No specific dose adjustment is typically required based on age alone, but caution is advised in patients with pre-existing liver or kidney impairment, or those taking multiple medications.
Clinical Information
Clinical Pearls
- The concentration of infant acetaminophen suspension was standardized to 160mg/5ml to reduce dosing errors. Always verify the concentration and use the provided dosing device.
- Educate caregivers thoroughly on accurate dosing by weight, not age, and the importance of not exceeding the maximum daily dose.
- Stress the danger of accidental overdose due to combination products (e.g., cold and flu medicines) that also contain acetaminophen.
- Liver toxicity is the primary concern with overdose; N-acetylcysteine is the antidote.
- Acetaminophen has no significant anti-inflammatory properties, unlike NSAIDs.
Alternative Therapies
- Ibuprofen (NSAID, also analgesic and antipyretic, but with anti-inflammatory properties and different side effect profile)
- Naproxen (NSAID, for older children/adults)
- Aspirin (not recommended for fever in children/adolescents due to Reye's syndrome risk)
Cost & Coverage
Average Cost:
Varies widely, typically low per 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 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'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 information about the medication taken, the amount, and the time it happened.