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Equate 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 2011
Label revision date
July 10, 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 2011
Label revision date
July 10, 2024
Manufacturer
Wal-Mart Stores Inc
Registration number
M013
NDC root
49035-946
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Equate™ is a liquid medication designed for infants aged 2 to 3 years to help reduce fever and relieve minor aches and pains. It contains acetaminophen (160 mg per 5 mL), which is effective for easing discomfort associated with common conditions like the cold, flu, headache, sore throat, and toothache.

This formulation is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free, making it a gentle option for young children. The pleasant grape flavor can make it easier for your little one to take. Always use the enclosed syringe for accurate dosing, and consult the packaging for more details on usage.

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 when you need it.

Dosage and Administration

Before using this product, it's important to note that it does not come with complete directions or warnings for adult use. Always make sure to follow the recommended dosage and never exceed the directed amount, as doing so can lead to an overdose.

To prepare the medication, start by shaking the bottle well. You’ll need to find the right dose using the provided dosing chart, which can be based on your child's weight or age. If you’re using a syringe, push the air out of it and insert the tip into the bottle opening. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the liquid back into the bottle. Next, pull the yellow part of the syringe until it reaches the correct dose and stays there. When giving the medication, dispense it 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. Always use the enclosed syringe designed for this product and replace the cap tightly to keep it child-resistant. 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, the dose is 5 mL.

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, it's important to ask 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 crucial to follow the recommended dosage and not exceed it, as doing so can lead to serious health risks. Always be mindful of these guidelines to ensure safe use of the medication.

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. 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.

It's important to consult a doctor if your child experiences a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, you should stop use and contact a doctor if new symptoms arise, if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, or if there is any 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. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any skin reactions, 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 new symptoms arise, if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, 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. Even if you don’t see any signs or symptoms, getting quick medical attention is crucial, as some effects may not be immediately apparent.

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 reach out for help. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. However, the insert does not indicate any known risks or contraindications associated with using acetaminophen while pregnant. Additionally, there are no recommended changes to the dosage for pregnant individuals, and no special precautions are noted.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it can be passed into your breast milk, which may pose risks to your infant. Therefore, exercise caution when considering this product while nursing, as your baby's safety is a top priority.

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 to 35 pounds, the recommended dose is 5 mL. Always use the enclosed syringe for accurate dosing.

Be aware of some important warnings: this product contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in 24 hours. Watch for any signs of severe skin reactions, such as redness, blisters, or rash, and seek medical help immediately if they occur. 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. Do not use this medication if your child has had an allergic reaction to it, has liver disease, or is taking the blood thinner warfarin. Always stop use and consult a doctor if new symptoms arise or if pain or fever worsens. In case of overdose, seek medical help right away.

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 how this medication may affect you.

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 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 monitor your kidney function and make any necessary adjustments to your treatment plan.

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. Mixing these medications can lead to serious complications, so ensuring safety is crucial.

Additionally, 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 has acetaminophen, don't hesitate to ask a healthcare professional for guidance. Always prioritize open communication about your medications to help prevent any harmful interactions.

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 the product remains safe and effective for your use.

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-thinning medication warfarin.

If you notice any new symptoms, if pain worsens or lasts more than 5 days, if fever increases or lasts more than 3 days, or if there is any redness or swelling, stop using the medication and contact a doctor.

FAQ

What is equate™ used for?

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

What is the active ingredient in equate™?

The active ingredient in equate™ is acetaminophen, which is present at a dosage of 160 mg per 5 mL.

What age group is equate™ suitable for?

Equate™ is suitable for infants aged 2 to 3 years.

How should I administer equate™?

Use only the enclosed syringe to administer equate™. Shake well before use and follow the dosing chart based on your child's weight or age.

What are the dosing instructions for equate™?

For children weighing 24-35 lbs (ages 2-3 years), the dose is 5 mL. For those under 24 lbs or under 2 years, consult a doctor.

Are there any warnings associated with equate™?

Yes, do not exceed 5 doses in 24 hours, as this may cause severe liver damage. Also, watch for severe skin reactions and consult a doctor if symptoms worsen.

Can I use equate™ if my child has liver disease?

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

Is equate™ safe to use during pregnancy?

There is no specific information provided regarding the use of equate™ during pregnancy, so consult a doctor before use.

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.

What should I do if my child experiences a skin reaction?

If your child experiences skin reddening, blisters, or rash, stop use and seek medical help right away.

Packaging Info

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

Packaging configurations for Equate Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

equate™ is a pediatric formulation designed for the relief of pain and reduction of fever in infants aged 2 to 3 years. This suspension liquid contains acetaminophen at a concentration of 160 mg per 5 mL. The product is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free, ensuring a safe option for young patients. It is presented in a grape-flavored formulation, packaged in a 2 FL OZ (59 mL) bottle. The dosing system is preferred by pediatricians and is intended for use with the enclosed syringe. For detailed usage instructions, refer to the side panel of the packaging.

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 dosing chart to determine the appropriate dosage based on the child's weight or age. It is essential to shake the product well before each use.

For dosing, the following guidelines should be adhered to:

  • For children weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dose.

  • For children weighing between 24 and 35 pounds, or aged 2 to 3 years, the recommended dose is 5 mL.

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

  1. Use only the enclosed syringe specifically designed for this product; do not substitute with any other dosing device.

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

  3. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

  4. Pull the yellow part of the syringe until it reaches and stays at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is crucial not to exceed 5 doses in a 24-hour period. After use, ensure that the cap is replaced tightly to maintain child resistance.

Healthcare professionals should be aware that this product does not contain complete warnings for adult use and should not be administered in excess of the directed dosage.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication 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.

This product is contraindicated in patients with a known history of allergic reactions to this product or any of its components.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dose may lead to serious health risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which is the maximum daily amount, or administering this product concurrently with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a 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 or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should advise caregivers to consult a physician prior to use if the child has a history of liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Caregivers should be advised to discontinue use and consult a healthcare provider if new symptoms arise, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if redness or swelling occurs, as these may indicate a serious condition.

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 five doses within a 24-hour period or who take this product concurrently with other medications containing acetaminophen. It is crucial for patients to monitor their intake to avoid such risks.

Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients are advised 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, patients should consult a healthcare professional without delay.

Patients are also instructed to stop use and contact a doctor if new symptoms arise, if pain worsens or lasts longer than five days, if fever intensifies or lasts more than three days, 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 a history of liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before using this product.

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 may be heightened, leading to serious hepatic complications. 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 Equate Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Equate Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dose is 5 mL, or as directed by a healthcare professional. It is essential to use the enclosed syringe for accurate dosing.

Warnings include a liver warning, as this product contains acetaminophen, which may cause severe liver damage if more than 5 doses are taken within 24 hours. Pediatric patients may also experience severe skin reactions, including symptoms such as skin reddening, blisters, or rash; in such cases, use should be discontinued immediately, and medical assistance sought. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

This product should not be used in children who have a history of allergic reactions to it or any of its ingredients, those with liver disease, or those taking the blood-thinning medication warfarin.

When administering this product, caregivers must not exceed the recommended dose. If new symptoms arise, pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, or if redness or swelling occurs, a doctor should be consulted, as these may indicate a serious condition.

In the event of an overdose, immediate medical help should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is critical, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not receive comprehensive directions or warnings regarding the use of this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect the safety and efficacy of the treatment in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary based on individual patient needs and responses. Given the lack of specific guidance for adult use, careful evaluation and clinical judgment are paramount when managing treatment in geriatric patients.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of acetaminophen during this period. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Lactating 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 potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 should be aware that quick medical attention is critical in managing overdose situations. Even in the absence of overt symptoms, the risk of delayed reactions necessitates thorough evaluation and monitoring of the patient.

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 limits the understanding of potential risks associated with the compound in nonclinical settings.

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. Patients should be advised to discontinue use and consult a doctor if new symptoms arise, if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dose, as this could lead to 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 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, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice if new symptoms arise, if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if there is any redness or swelling.

Drug Information (PDF)

This file contains official product information for Equate 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 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.