Symptom checker
Select audience type

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

ADD CONDITION

items per page

Dye Free Infants Pain and Fever

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 2024
Label revision date
April 9, 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 2024
Label revision date
April 9, 2024
Manufacturer
WALGREENS
Registration number
M013
NDC root
0363-7015
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

This medication is designed to help you feel better when you're experiencing discomfort from minor aches and pains, such as those caused by the common cold, flu, headache, sore throat, or toothache. It also works to reduce fever, providing temporary relief when you're not feeling well.

By addressing these symptoms, this medication can help you manage your discomfort and support your recovery. Always remember to use it as directed for the best results.

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 you give this medication to your child, make sure to follow the directions carefully. First, do not exceed the recommended dose. It's important to shake the bottle well before using it. To find the right dose, refer to the dosage chart based on your child's weight or age. If your child weighs under 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24 and 35 pounds, aged 2 to 3 years, the dose is 5 mL.

When you're ready to administer the medication, push the air out of the syringe and insert the tip into the bottle opening. Flip the bottle upside down and pull the yellow part of the syringe to draw the correct dose. Dispense the liquid slowly into your child's mouth, aiming for the inner cheek. You can repeat this dose every 4 hours as needed, but do not give more than 5 doses in a 24-hour period. After use, make sure to tightly replace the cap to keep it child-resistant. Always use the enclosed syringe designed for this product and avoid using any other dosing device.

What to Avoid

You should avoid using this product if your child is allergic to acetaminophen or any of its inactive ingredients. Additionally, do not combine it with any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with a doctor or pharmacist.

While using this product, make sure to follow the recommended dosage carefully and never exceed it, as doing so can lead to serious health risks. Always prioritize safety and seek guidance if you have any questions or concerns.

Side Effects

You should be aware of some important warnings and potential side effects when using this product, which contains acetaminophen. Taking more than 5 doses in 24 hours or using it with other medications that also contain acetaminophen can lead to severe liver damage. Additionally, 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.

It's also important to consult a doctor if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting. You should 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. Always check with a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

Warnings and Precautions

It's important to be aware of some key warnings and precautions when using this product, which contains acetaminophen. Taking more than 5 doses in 24 hours can lead to severe liver damage, especially if combined with other medications that also contain acetaminophen. Additionally, be cautious 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 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 wise to check with a doctor if your child has liver disease or is taking the blood thinner warfarin. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if no symptoms are present, as quick action is crucial. You should also stop using the product and call your 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 may indicate a serious condition.

Overdose

If your child takes more than 5 doses of this medication in a 24-hour period, it can lead to severe liver damage. It's also important to be cautious if your child is using this product alongside other medications that contain acetaminophen (a common pain reliever), as this combination can also result in serious liver harm.

If you suspect an overdose, look for signs such as unusual tiredness, nausea, vomiting, or yellowing of the skin or eyes. If you notice any of these symptoms or believe your child may have taken too much, seek immediate medical help. It's always better to be safe and get professional advice in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. Before using it, you should consult your doctor to discuss any potential risks to your fetus, as there may be concerns that need careful consideration.

Additionally, dosage adjustments might be necessary, so it's essential to seek guidance from your healthcare provider. While using this product, monitor yourself for any adverse effects and report them to your healthcare provider immediately if they occur. Your health and the health of your baby are the top priority, so open communication with your doctor is crucial.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which means your nursing infant could be exposed to it. Because of this potential risk, caution is advised when considering this product while nursing. Always prioritize your health and your baby's safety by discussing any medications or treatments with your healthcare provider.

Pediatric Use

If you have a child under 24 pounds (or under 2 years old), it's important to consult a doctor before using this medication. For children who weigh between 24 and 35 pounds (ages 2 to 3 years), the recommended dose is 5 mL. Always use your child's weight to determine the correct dose; if you don't know their weight, you can use their age instead.

Make sure not to give more than 5 doses in a 24-hour period. It's also crucial to use the syringe that comes with the product, as it is specifically designed for accurate dosing. Avoid using any other dosing device to ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with 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 kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, be aware that other medications may also contain acetaminophen, so always check labels to avoid exceeding this limit.

To ensure your safety, monitor your total acetaminophen intake closely and consult your healthcare provider if you have any questions or concerns about using products with this ingredient. Your liver health is crucial, and taking these precautions can help protect it.

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. Mixing these medications can lead to serious complications, so always check first.

Additionally, you should avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask a healthcare professional for guidance. Keeping open communication with your healthcare provider helps ensure safe and effective treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Proper storage and careful handling are essential for your safety and the product's reliability.

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 gets worse or lasts more than 3 days, stop using the medication and contact a doctor. Additionally, seek medical advice if new symptoms appear or if there is any redness or swelling.

FAQ

What is this drug used for?

This drug reduces fever and relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

How should I administer this drug to my child?

Use the enclosed syringe to measure the dose. Shake well before using and dispense the liquid slowly into your child's mouth, toward the inner cheek.

What is the recommended dosage for children aged 2-3 years?

For children weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

What should I do if my child has a severe sore throat?

If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Are there any contraindications for using this drug?

Do not use this drug if your child is allergic to acetaminophen or any inactive ingredients, or if they are taking another drug containing acetaminophen.

What should I do in case of an overdose?

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

Can this drug be used during pregnancy?

The safety of this product during pregnancy has not been established, so consult a doctor before use if pregnant or planning to become pregnant.

What are the storage conditions for this drug?

Store the drug between 20-25°C (68-77°F).

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, as these could be signs of a serious condition.

Is there a risk of liver damage with this drug?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours or with other drugs containing acetaminophen.

Packaging Info

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

Packaging configurations for Dye Free Infants Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product, identified by SPL code 34089-3, contains acetaminophen as the active ingredient, with each 5 mL of the liquid formulation delivering 160 mg of acetaminophen. The inactive ingredients include glycerin, high fructose corn syrup, purified water, sodium benzoate, sorbitol, citric acid, artificial flavor, sodium citrate, FD&C red #40, and FD&C blue #1. The formulation is presented as a clear, red liquid with a cherry flavor.

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 instruct caregivers to adhere strictly to the recommended dosage and administration guidelines. The medication should not be administered in excess of the directed amount. Prior to use, the bottle must be shaken well to ensure proper mixing of the contents.

For dosing, caregivers are advised to refer to the dosage chart below, utilizing the child's weight for the most accurate dosing. If weight is not available, age may be used as a secondary reference.

Dosage Chart:

  • For children weighing under 24 lbs (under 2 years of age), the caregiver should consult a physician for the appropriate dose.

  • For children weighing between 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL.

The administration technique involves the following steps:

  1. Push 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 prescribed dose.

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

Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period. After use, ensure the cap is replaced tightly to maintain child resistance.

It is imperative to use only the enclosed syringe specifically designed for this product; no other dosing devices should be utilized. Caregivers should follow any additional instructions provided by a healthcare professional.

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 other medications, consultation with a healthcare professional is advised.

  • In patients with a known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

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

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen has been associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise parents or guardians to consult a physician if a child experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting.

Prior to administration, it is essential to inquire about the child’s medical history. Specifically, consultation with a healthcare provider is recommended if the child has a history of liver disease. Additionally, if the child is currently taking warfarin or any other anticoagulant, it is advisable to seek guidance from a doctor or pharmacist before use.

In cases of suspected overdose, immediate medical attention is crucial. Parents or caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is limited to 5 doses within a 24-hour period. Additionally, the risk of liver damage increases if the product is taken concurrently with other medications containing acetaminophen.

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.

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.

Further, patients should stop using the product and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients with liver disease consult a doctor prior to using this product. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before use.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose and associated hepatotoxicity may be heightened. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Packaging configurations for Dye Free Infants Pain and Fever.
Details

Pediatric Use

Pediatric patients under 24 lbs (under 2 years) should consult a doctor before use. For children weighing between 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL. Dosing should be determined by weight; if weight is not available, age may be used as a guide. It is important not to exceed 5 doses within a 24-hour period. Only the enclosed syringe specifically designed for this product should be used for dosing; other dosing devices are not recommended.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. The use of this product should be carefully considered, weighing the benefits against any potential risks.

Dosage adjustments may be necessary for pregnant patients; therefore, it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Additionally, special precautions should be taken to monitor for any adverse effects during pregnancy. Any adverse effects that occur should be reported to a healthcare provider immediately.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the risk of infant exposure.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Exceeding this limit, particularly in patients with compromised liver function, may significantly increase the risk of hepatotoxicity. Additionally, caution should be exercised if the patient is concurrently using other medications that contain acetaminophen, as this may further elevate the risk of liver injury. Regular assessment of liver function is recommended to ensure patient safety and to mitigate potential adverse effects.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of severe liver injury. Healthcare professionals should be vigilant in monitoring patients for signs of liver dysfunction following such an overdosage.

Additionally, co-administration of this product with other medications containing acetaminophen can also lead to severe liver damage. It is essential to assess the patient's medication history to identify any concurrent use of acetaminophen-containing products.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests. Early intervention is crucial to mitigate the risk of long-term hepatic complications.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified adverse reactions associated with the use of acetaminophen. Notable among these are severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if their child is allergic to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should be advised to discontinue 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 there is any redness or swelling, as these may indicate a serious condition.

Patients must be reminded to adhere strictly to the recommended dosage to avoid the risk of overdose. Additionally, it is advisable to consult a doctor before use if the child has liver disease. Patients should also seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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 Dye Free 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 Dye Free 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.

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.