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Equate Childrens 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 2013
Label revision date
February 23, 2026
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 2013
Label revision date
February 23, 2026
Manufacturer
Wal-Mart Stores Inc
Registration number
M013
NDC root
49035-313
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Equate™ is an oral suspension that contains acetaminophen (a common pain reliever and fever reducer) at a concentration of 160 mg per 5 mL. It is designed for children aged 2 to 11 years and provides fast, effective relief from fever and minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches.

This product is aspirin-free, ibuprofen-free, and alcohol-free, making it a gentle option for young children. It comes in a pleasant bubble gum flavor and includes a dosage cup for easy measurement.

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 medication is designed to provide you with relief when you're feeling unwell, making it easier to manage your symptoms and get back to your daily activities.

Dosage and Administration

Before using this product, make sure to shake it well. You’ll need to find the right dose for your child based on their weight or age. If your child weighs less than 24 pounds or is under 2 years old, it’s best to ask a doctor for the appropriate dose. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the dose is 5 milliliters (mL). As your child grows, the dose increases: 7.5 mL for ages 4 to 5 years (36-47 pounds), 10 mL for ages 6 to 8 years (48-59 pounds), 12.5 mL for ages 9 to 10 years (60-71 pounds), and 15 mL for 11-year-olds (72-95 pounds).

When you’re ready to give the dose, remove the child protective cap and squeeze the correct amount into the enclosed dosing cup. You can repeat this dose every 4 hours as long as your child has symptoms, but remember not to exceed 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 product if your child has ever had an allergic reaction to it or any of its 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.

Always follow the recommended dosage and never exceed it, as doing so can lead to serious health risks. If you have any questions or concerns about using this product, please reach out to a healthcare professional for guidance.

Side Effects

Taking acetaminophen can lead to some serious side effects, so it's important to be aware of them. One major concern is the risk of severe liver damage, especially if your child takes more than five doses in a 24-hour period or uses it alongside other medications containing acetaminophen. Additionally, be cautious of potential severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If any of these occur, stop using the medication and seek medical help immediately.

You should also consult a doctor if your child experiences a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. It's advisable to stop using acetaminophen and contact a healthcare professional if pain worsens or lasts more than five days, fever increases or lasts more than three days, new symptoms appear, or if there is redness or swelling. Always check with a doctor before use if your child has liver disease or is taking blood thinners like 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. 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. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate signs or symptoms. You should also 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, as these could indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial, even if you don’t notice 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 or someone else is experiencing these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the product insert does not provide specific information about using this product during pregnancy. There are no explicit warnings or contraindications mentioned for pregnant individuals, and no dosage modifications or special precautions are specified.

While this may suggest that the product is considered safe, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure it aligns with your individual health needs.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution and seek professional advice to ensure the safety of both you and your baby.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing guidelines carefully to ensure their safety. For children under 2 years old, you should consult a doctor before administering any dose. For children aged 2 to 11 years, the dosage varies based on their weight: for example, a child weighing 24-35 pounds (2-3 years old) should receive 5 mL, while a child weighing 72-95 pounds (11 years old) can take 15 mL. Always use the dosing cup that comes with the product, as other devices may not provide the correct amount.

Remember, never give more than the recommended dose, as this can lead to an overdose. This medication is designed to provide fast and effective relief from fever and pain for children in this age group.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 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. Acetaminophen can interact with warfarin, which may affect how well it works and could increase the risk of bleeding.

Always keep your healthcare provider informed about all 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 safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance. 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.

Always handle the product with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

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 equate™?

Equate™ is an acetaminophen oral suspension that contains 160 mg of acetaminophen per 5 mL.

What does equate™ do?

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

What age group is equate™ suitable for?

Equate™ is suitable for children aged 2 to 11 years.

How should I administer equate™?

Use the enclosed dosing cup to measure the dose and shake well before using. Repeat the dose every 4 hours while symptoms last, but do not exceed 5 doses in 24 hours.

What are the dosage recommendations for equate™?

Dosage varies by weight: for children weighing 24-35 lbs (2-3 years), give 5 mL; for 36-47 lbs (4-5 years), give 7.5 mL; for 48-59 lbs (6-8 years), give 10 mL; for 60-71 lbs (9-10 years), give 12.5 mL; and for 72-95 lbs (11 years), give 15 mL.

Are there any warnings associated with equate™?

Yes, do not exceed the recommended dose, and avoid using it with other drugs containing acetaminophen. Severe liver damage may occur if you do.

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.

Can I use equate™ during pregnancy?

The insert does not provide specific information regarding the use of this product during pregnancy, so consult a doctor before use.

What should nursing mothers know about equate™?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Equate Childrens Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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 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 within a 24-hour period.

The following dosage chart provides specific dosing recommendations:

  • For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

It is critical not to exceed the recommended dosage, and healthcare professionals should be aware of the overdose warning associated with this product. Only the enclosed dosing cup should be used for measurement; other dosing devices are not appropriate.

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 history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

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

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should closely monitor the dosage to prevent potential hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised to rule out serious underlying conditions.

Healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease, before recommending this product. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Healthcare providers should instruct caregivers to contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms develop, or if there is any redness or swelling. These signs may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who take acetaminophen concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor 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.

It is recommended that patients consult a doctor prior to use if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before using acetaminophen.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are concurrently taking warfarin. This interaction could potentially affect the anticoagulant's efficacy and safety profile. Monitoring of INR levels may be warranted to ensure appropriate anticoagulation management in patients receiving both medications.

Packaging & NDC

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

Packaging configurations for Equate Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive fast and effective relief of fever and pain with this product. The recommended dosing is based on weight and age, as follows:

  • For patients under 24 lb (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.

It is crucial to use only the enclosed dosing cup specifically designed for this product and to adhere strictly to the recommended dosages to avoid overdose.

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 insert does not provide specific information regarding the use of this product during pregnancy. There are no explicit warnings or contraindications mentioned for pregnant individuals. Additionally, no dosage modifications for pregnant individuals are specified, and no special precautions regarding use during pregnancy are included in the insert. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product on a nursing infant are not well studied; therefore, caution is advised.

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 evaluate 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 medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with the overdose.

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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity 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 potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

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. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Equate Childrens 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 Equate Childrens 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

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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.