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Infants Pain and Fever

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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 2022
Label revision date
December 1, 2025
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 2022
Label revision date
December 1, 2025
Manufacturer
WALGREEN COMPANY
Registration number
M013
NDC root
0363-6002
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 designed for infants to help relieve pain and reduce fever. It comes in an oral suspension form with a natural cherry flavor and is free from dyes, sugar, alcohol, and other additives. This medication is effective for alleviating minor aches and pains associated with common conditions such as the cold, flu, headaches, sore throats, and toothaches.

By working to lower fever and ease discomfort, acetaminophen provides a gentle option for parents looking to care for their little ones during times of illness. Always consult with a healthcare professional for guidance on appropriate use.

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 cold and flu, as well as headaches, sore throats, and toothaches.

This medication is safe in terms of teratogenic effects, meaning it does not cause birth defects. You can feel confident using it for relief from these common ailments.

Dosage and Administration

Before using this product, make sure to shake the bottle well. To find the right dose for your child, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age. Once you have the correct dose, push the air out of the enclosed syringe designed for this product, then insert the syringe tip into the bottle opening. Flip the bottle upside down and pull the yellow part of the syringe to draw up the correct amount of liquid.

When administering the medication, dispense it slowly into your child's mouth, aiming for the inner cheek. You can repeat this dose every 4 hours as long as your child continues to show symptoms, but remember not to give more than 5 doses in a 24-hour period. After use, make sure to replace the cap tightly to keep it child-resistant, and always use the syringe that comes with the product—do not use any other dosing device.

What to Avoid

It's important to be cautious when using this medication. You should not use it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist for clarification.

Additionally, if your child has a known allergy to acetaminophen or any of the inactive ingredients in this product, do not use it. Always prioritize safety and seek professional advice if you have any questions or concerns.

Side Effects

You should be aware that 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, acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rashes. If you notice any of these symptoms, stop using the product and seek medical help immediately.

If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. It's also important to avoid using this product if your child is allergic to acetaminophen or any of its inactive ingredients. Always check with a doctor or pharmacist if your child is taking blood thinners like warfarin or has liver disease. If pain or fever worsens or lasts longer than the recommended time, or if new symptoms arise, stop use and consult a healthcare professional. In case of overdose, seek medical assistance immediately.

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. Be aware that acetaminophen may also 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. Additionally, if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

Before using this product, it's important to ask a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. Always follow the recommended dosage and do not exceed it. If you suspect an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222, as quick attention is crucial for both adults and children.

You should stop using the product and call your doctor if your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling. These could indicate a more serious condition that needs medical attention.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick action is crucial for both adults and children, 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, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When considering the use of this product during pregnancy, it's important to note that there are no specific guidelines or safety information available. This means that there are no known risks to the fetus, contraindications (conditions that would make the use of the product inadvisable), or recommended dosage adjustments for pregnant individuals.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication or product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no particular considerations or precautions mentioned about lactation or the possibility of the product being present in breast milk. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your nursing infant.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing guidelines carefully. For children under 2 years old, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24-35 pounds, the recommended dose is 1.5 mL. Always use the enclosed syringe for accurate dosing and never exceed the maximum of 5 doses in 24 hours, as taking too much can lead to severe liver damage.

Be aware of potential warnings: this medication can cause serious skin reactions, so if you notice any redness, blisters, or rash, stop using it and seek medical help immediately. If your child has a severe sore throat that lasts more than 2 days or is accompanied by other symptoms like fever or nausea, consult a doctor. Additionally, do not use this medication with any other products containing acetaminophen, and check with a doctor if your child has liver disease or is taking blood thinners like warfarin. In case of an overdose, seek medical assistance right away, even if there are no immediate symptoms.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If your child has liver disease, it's important to consult a doctor before using this product. It contains acetaminophen, which can be harmful to the liver. Be aware that taking more than 5 doses in a 24-hour period—this is the maximum daily amount—can lead to severe liver damage. Additionally, be cautious about using other medications that also contain acetaminophen, as this can increase the risk of liver problems. Always prioritize safety and seek professional guidance when it comes to managing your child's health.

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. Acetaminophen may interact with warfarin, which could affect how well it works.

Always discuss any medications or tests with your healthcare provider to ensure safety and effectiveness. They can help you understand potential interactions and make informed decisions about your child's health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage.

If you have any components that come with the product, make sure to keep them in a clean and safe environment. Proper storage and careful handling are key to ensuring that everything works as intended.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as symptoms persist, but do not exceed 5 doses in a 24-hour period. It's important to consult a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

If your child's pain worsens or lasts more than 5 days, or if a fever worsens or lasts more than 3 days, stop using the medication and seek medical advice. Additionally, contact a doctor if new symptoms appear or if there is any redness or swelling.

FAQ

What is Acetaminophen used for?

Acetaminophen is used to reduce fever and relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

How should I administer Acetaminophen to my child?

Use the enclosed syringe specifically designed for this product. Shake well before using, and dispense the liquid slowly into your child's mouth, toward the inner cheek.

What is the maximum dosage for Acetaminophen?

Do not give more than 5 doses in 24 hours, and repeat doses every 4 hours while symptoms last.

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, it may cause severe skin reactions.

Can I use Acetaminophen if my child is allergic to it?

No, do not use Acetaminophen if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical.

Is Acetaminophen safe to use during pregnancy or while nursing?

The provided information does not specify any warnings or recommendations regarding the use of Acetaminophen during pregnancy or lactation.

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

Stop use and ask a doctor if pain lasts more than 5 days or if fever lasts more than 3 days, or if new symptoms occur.

Packaging Info

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

Packaging configurations for Infants Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen is presented as an oral suspension with a strength of 160 mg per 5 mL. The formulation includes a natural cherry flavor and is free of dyes, sugar, ibuprofen, aspirin, parabens, and high fructose corn syrup. Additionally, there is no added alcohol in the product.

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

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. Dosing should be determined using the provided dosing chart; weight is the preferred method for determining the appropriate dose, although age may be used if weight is not available.

To prepare the dose, healthcare professionals should follow these steps:

  1. Push the air out of the syringe before inserting the syringe tip into the bottle opening.

  2. Invert the bottle and pull the yellow part of the syringe to the correct dose.

  3. Administer the liquid slowly into the child's mouth, directing it toward the inner cheek.

The recommended dosing frequency is every 4 hours as needed while symptoms persist. However, it is critical not to exceed 5 doses within a 24-hour period. After use, ensure that the cap is replaced tightly to maintain child resistance.

Only the enclosed syringe, specifically designed for use with this product, should be utilized for dosing. The use of any other dosing device is not recommended. It is important to adhere to the overdose warning and not exceed the directed dosage.

Contraindications

Use of this product is contraindicated in the following situations:

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

Additionally, this product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

General Precautions Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Additionally, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin. It is crucial to adhere strictly to the recommended dosage and not exceed it during treatment.

Emergency Medical Help Instructions In the event of an overdose, immediate medical attention is essential. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Stop Taking and Call Your Doctor Instructions Discontinuation of this product is advised if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, or who take this product in conjunction with other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Patients with liver disease should consult a doctor before using this product. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare professional or pharmacist prior to use. It is crucial for patients to adhere to the recommended dosage and to stop use and consult a doctor if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is critical for both adults and children.

Drug Interactions

Patients should consult a healthcare professional prior to using acetaminophen if they are concurrently taking warfarin, a blood-thinning medication. The combination may lead to potential interactions that could affect the efficacy and safety of warfarin therapy.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen. Therefore, routine monitoring or dosage adjustments are not indicated beyond the specific consideration of its use with warfarin.

Packaging & NDC

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

Packaging configurations for Infants Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age should not be given this product without consulting a doctor. For children aged 2 to 3 years weighing between 24-35 lbs, the recommended dose is 1.5 mL. It is crucial to adhere to the dosing chart and, when possible, use weight for dosing; otherwise, age may be used.

Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. This product contains acetaminophen, and caution is advised due to the potential for severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

Parents and caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, a doctor or pharmacist should be consulted. Additionally, this product should not be administered to children with known allergies to acetaminophen or any inactive ingredients.

In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center is recommended. Quick medical attention is critical for both children and adults, even if no signs or symptoms are present. Caregivers should ensure that only the enclosed syringe designed for this product is used for dosing, and should not exceed the directed dosage.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. Currently, there is no information available about safety concerns, dosage modifications, or special precautions that should be taken when considering this product for pregnant patients. Additionally, no contraindications in pregnancy have been identified, and there is no data provided regarding potential risks to the fetus. Healthcare professionals should exercise caution and consider the lack of information when prescribing this product to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

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.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 5 doses within a 24-hour period is exceeded. Additionally, caution is advised when administering this product in conjunction with other medications that also contain acetaminophen, as this may further increase the risk of liver injury. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and 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 keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice 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.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe use of this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin. Patients should discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

Drug Information (PDF)

This file contains official product information for Infants Pain and Fever, 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 Infants Pain and Fever, 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.

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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.