Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Pain Relief

Last content change checked dailysee data sync status

Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1996
Label revision date
September 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1996
Label revision date
September 11, 2024
Manufacturer
H E B
Registration number
M013
NDC root
37808-130
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Acetaminophen is a medication commonly used to relieve pain and reduce fever in children aged 2 to 11 years. This oral suspension, which comes in a pleasant grape flavor, provides fast and effective relief from minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

As a pain reliever and fever reducer, acetaminophen works by lowering fever and alleviating discomfort, making it a go-to option for parents seeking to help their children feel better during illness. It is important to note that this formulation is free from parabens, alcohol, aspirin, and ibuprofen, ensuring a gentle choice for young patients.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the common cold, flu, headaches, sore throats, and toothaches.

This means that if you're feeling under the weather or experiencing mild pain, this medication can provide some relief to help you feel better.

Dosage and Administration

Before using this product, make sure to shake it well. To find the right dose for your child, refer to the dosage chart based on their weight or age. If your child weighs less than 24 pounds or is under 2 years old, it's best to consult a doctor for the appropriate dose. For children weighing between 24 to 35 pounds (ages 2-3 years), the dose is 5 mL; for those weighing 36 to 47 pounds (ages 4-5 years), it's 7.5 mL; and for children weighing 48 to 59 pounds (ages 6-8 years), the dose is 10 mL. If your child weighs between 60 to 71 pounds (ages 9-10 years), the dose is 12.5 mL, and for those weighing 72 to 95 pounds (age 11 years), the dose is 15 mL.

When administering the medication, remove the child protective cap and squeeze the correct dose into the enclosed dosing cup. You can repeat this dose every 4 hours as long as your child's symptoms persist, but remember not to give more than 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide the correct measurement.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if your child has ever had an allergic reaction to it or any of its ingredients.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

You should also consult a doctor if your child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. It's important to stop use and contact a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition. Always check with a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. It's important to be aware of potential severe skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

If your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. You should also stop using the product and contact a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition. In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if no symptoms are present, as quick medical attention is crucial.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or have concerns about an overdose, don’t hesitate to get help right away. Your safety is the top priority.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available regarding its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using acetaminophen. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

When giving this medication to children aged 2 to 11 years, it's important to use their weight for dosing, but you can also use their age if you don't have their weight. For example, a child weighing 24-35 pounds (about 2-3 years old) should receive 5 mL, while a child weighing 72-95 pounds (11 years old) should receive 15 mL. Remember, you should not give more than 5 doses in a 24-hour period.

Before using this medication, check with a doctor if your child has ever had an allergic reaction to it or any of its ingredients, has liver disease, or is taking the blood thinner warfarin. If your child's pain worsens or lasts more than 5 days, if their fever gets worse or lasts more than 3 days, or if new symptoms appear, stop using the medication and consult a doctor.

Geriatric Use

When considering this medication for older adults, it's important to note that the product does not provide specific directions or complete warnings for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional to ensure safe and appropriate use.

Always discuss any existing health conditions or medications with your doctor, as they can help determine the best approach tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or seek clarification about the medication.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If your child has liver disease, it's important to consult with a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional advice in these situations.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. Warfarin helps prevent blood clots, and combining it with other medications can increase the risk of bleeding or other complications.

Always keep your healthcare provider informed about all the medications your child is taking to ensure their safety and well-being. This way, you can avoid any potential interactions and make informed decisions about their treatment.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before using the product, check the printed neckband; do not use it if the neckband is broken or missing, as this could indicate that the product is compromised.

By following these simple storage and handling guidelines, you can help ensure that your product remains safe and effective for use.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as your symptoms persist. However, do not exceed 5 doses in a 24-hour period. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial even if you don't see any symptoms.

FAQ

What is Acetaminophen used for?

Acetaminophen is a pain reliever and fever reducer used for children ages 2 to 11 years. It helps reduce fever and relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What is the recommended dosage for Acetaminophen?

The dosage of Acetaminophen depends on your child's weight and age. For example, a child weighing 24-35 lbs (2-3 years) should take 5 mL, while a child weighing 72-95 lbs (11 years) should take 15 mL.

How often can I give Acetaminophen to my child?

You can repeat the dose every 4 hours while symptoms last, but do not give more than 5 doses in 24 hours.

Are there any warnings associated with Acetaminophen?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours or with other drugs containing acetaminophen. Additionally, if your child has ever had an allergic reaction to this product, do not use it.

Can I use Acetaminophen if my child has liver disease?

You should ask a doctor before using Acetaminophen if your child has liver disease.

Is Acetaminophen safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Acetaminophen during pregnancy or nursing mothers.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if no signs or symptoms are noticed.

What should I do if my child's symptoms do not improve?

Stop use and ask a doctor if pain gets worse or lasts more than 5 days, fever gets worse or lasts more than 3 days, new symptoms occur, or redness or swelling is present.

Packaging Info

Below are the non-prescription pack sizes of Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Acetaminophen Oral Suspension contains 160 mg of acetaminophen per 5 mL. This formulation is designed as a pain reliever and fever reducer specifically for children aged 2 to 11 years. The product is presented in a 4 FL OZ (118 mL) bottle and features a grape flavor. It is formulated without parabens, alcohol, aspirin, or ibuprofen, ensuring a safe option for pediatric use. The suspension provides fast and effective relief of pain and fever in children.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the child's weight or age. It is essential to shake the product well before each use.

To administer the dose, remove the child protective cap and squeeze the appropriate amount into the enclosed dosing cup. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

Dosage Chart:

  • For children weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

  • For children weighing 24-35 lb or aged 2-3 years, the dose is 5 mL.

  • For children weighing 36-47 lb or aged 4-5 years, the dose is 7.5 mL.

  • For children weighing 48-59 lb or aged 6-8 years, the dose is 10 mL.

  • For children weighing 60-71 lb or aged 9-10 years, the dose is 12.5 mL.

  • For children weighing 72-95 lb or aged 11 years, the dose is 15 mL.

It is critical not to exceed the recommended dosage, and healthcare professionals should advise caregivers to follow the dosing instructions carefully to avoid the risk of overdose. Only the enclosed dosing cup should be used for measurement; other dosing devices are not appropriate for this product.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

  • In patients with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

  • Exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is recommended.

Patients should be instructed to stop using the product and consult a healthcare professional if any of the following occur: pain worsens or lasts longer than five days, fever worsens or persists beyond three days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

In cases of suspected overdose, immediate medical attention is crucial. Patients or caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is essential for optimal outcomes.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily dosage of acetaminophen is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a healthcare professional prior to use.

There is also an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is crucial to consult a doctor promptly.

Patients should also be instructed to stop use and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Furthermore, it is recommended that patients consult a healthcare provider before using this product if they are taking the blood-thinning medication warfarin, as interactions may occur.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with dosing based on weight and age. The recommended doses are as follows:

  • For patients under 24 lb and under 2 years, consultation with a doctor is advised.

  • For those weighing 24-35 lb (2-3 years), the dose is 5 mL.

  • For patients weighing 36-47 lb (4-5 years), the dose is 7.5 mL.

  • For those weighing 48-59 lb (6-8 years), the dose is 10 mL.

  • For patients weighing 60-71 lb (9-10 years), the dose is 12.5 mL.

  • For those weighing 72-95 lb (11 years), the dose is 15 mL.

Dosing should primarily be based on weight; however, age may be used if weight is not available. It is important not to exceed 5 doses within a 24-hour period.

Caution is advised in pediatric patients with a history of allergic reactions to this product or any of its ingredients. Consultation with a healthcare professional is recommended prior to use in children with liver disease or those taking the anticoagulant warfarin.

Parents and caregivers should discontinue use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Monitoring for adverse effects and therapeutic efficacy is recommended, as elderly patients may have an altered pharmacokinetic and pharmacodynamic profile. Dose adjustments may be necessary based on individual patient assessments and clinical judgment.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the benefits against any potential risks when acetaminophen is deemed necessary during pregnancy. Further research may be warranted to clarify the implications of acetaminophen use in this population.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals are advised to remain vigilant and act swiftly, as timely medical attention can significantly influence the outcome of an overdose situation. It is crucial to monitor the patient closely for any emerging symptoms, even if they initially appear asymptomatic.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dosage, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Pain Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.