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Pain Reliever Fever Reducer

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Active ingredient
Acetaminophen 120 mg
Other brand names
Dosage form
Suppository
Route
Rectal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
May 3, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 120 mg
Other brand names
Dosage form
Suppository
Route
Rectal
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 2010
Label revision date
May 3, 2023
Manufacturer
Walgreen Company
Registration number
ANDA070607
NDC root
0363-0579
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 SUPPOSITORIES 120 mg are a type of medication designed to help relieve pain and reduce fever in children aged 3 to 6 years. This product works by lowering fever and alleviating minor aches, pains, and headaches, making it a useful option for parents looking to comfort their little ones during times of discomfort.

These suppositories contain 120 mg of acetaminophen (a common pain reliever and fever reducer) and come in a package of 12. They are recommended by pharmacists and can be compared to other products containing the same active ingredient, such as FeverAll®.

Uses

You can use this medication to help reduce fever and relieve minor aches, pains, and headaches. It's designed to make you feel more comfortable when you're experiencing these common symptoms.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

When using this product, it's important to follow the instructions carefully. First, remove the wrapper from the suppository. You will need to insert the suppository well up into the rectum. Make sure not to use more than the recommended amount.

For children aged 3 to 6 years, you can use one suppository every 4 to 6 hours, but do not exceed five doses in a 24-hour period. If your child is under 3 years old, do not use this product unless directed by a doctor. Always ensure you are following these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this medication if you are allergic to acetaminophen, as it can cause serious reactions. Additionally, do not take it alongside any other medications that contain acetaminophen, whether they are prescribed or available over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with your doctor or pharmacist for guidance. Taking these precautions will help ensure your safety and well-being.

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 rash. If you notice any of these symptoms, stop using the product immediately and seek medical help.

It's important not to use this medication if your child is allergic to acetaminophen or if they are taking any other drugs that contain it. Before using this product, consult a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. You should also stop use and contact a doctor if a fever lasts more than 3 days, pain persists for more than 5 days or worsens, new symptoms appear, or if there is redness or swelling in the painful area, as these could indicate a serious condition.

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. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any skin reactions, stop using the product immediately and seek medical help.

Before using this medication, consult your doctor if your child has liver disease or is taking the blood-thinning medication warfarin. If your child accidentally swallows too much or if you suspect an overdose, get emergency medical help right away or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate symptoms.

You should also stop using the product and call your doctor if your child's fever lasts more than 3 days, pain lasts more than 5 days or worsens, new symptoms appear, or if there is redness or swelling in the painful area, as these could indicate a more serious condition.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick medical attention is crucial, especially for 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 suspect an overdose, don’t wait for symptoms to appear—get help right away. Your prompt action can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are considering using this product for a child under 3 years old, it’s important to consult a doctor first. Additionally, if your child has liver disease or is taking the blood-thinning medication warfarin, you should also seek medical advice before using this product. Please note that the information provided does not include directions or warnings for adult use, so it is essential to follow these guidelines carefully to ensure safety.

Lactation Use

If you are breastfeeding and considering using acetaminophen suppositories, you can feel reassured that there are no specific warnings or considerations mentioned for nursing mothers in the drug insert. This means that, based on the available information, it is generally considered safe for you to use this medication while breastfeeding.

However, as always, it's a good idea to consult with your healthcare provider before taking any medication to ensure it’s appropriate for your individual situation. They can provide personalized advice and address any concerns you may have about your health and your baby's well-being.

Pediatric Use

When it comes to using this medication in children, it's important to follow specific guidelines to ensure their safety. For children under 3 years old, you should avoid using this medication unless a doctor specifically advises you to do so. If your child is between 3 and 6 years old, you can administer 1 suppository every 4 to 6 hours, but be sure not to exceed 5 doses in a 24-hour period.

Always consult with your child's healthcare provider if you have any questions or concerns about the appropriate use of this medication for your child. Their guidance is crucial in ensuring your child's health and safety.

Geriatric Use

When considering this product for older adults, it's important to note that there are no specific directions or warnings provided for adult use. This means that if you are caring for an older adult, you should consult with a healthcare professional to ensure the product is appropriate for their needs. Always prioritize safety and seek guidance tailored to the unique health considerations of older individuals.

Renal Impairment

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

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

Hepatic Impairment

If your child has liver 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. Additionally, using other medications that also contain acetaminophen can increase the risk of harm.

Before giving this product to your child, please consult with a doctor if they have any liver disease. This ensures that you are making safe choices regarding their health.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you are on blood thinners like warfarin. Warfarin helps prevent blood clots, but it can interact with other drugs and affect how well it works. This means that taking certain medications together can increase your risk of bleeding or make warfarin less effective.

Always keep your healthcare provider informed about all the medications and supplements you are using. This way, they can help you manage your treatment safely and effectively.

Storage and Handling

To ensure the best quality and safety of your product, store it at a temperature between 20-25°C (68-77°F) or in a cool place. This helps maintain its effectiveness. Each suppository is individually wrapped for your protection, so be sure to check that the wrapper is intact. If the printed wrapper is opened or damaged, do not use the suppository, as this could compromise its safety.

Always handle the product with clean hands and avoid touching the inside of the wrapper to maintain its sterility (the absence of germs). Following these guidelines will help you use the product safely and effectively.

Additional Information

You will administer this medication rectally, using one suppository every 4 to 6 hours, but do not exceed five doses in a 24-hour period. It's important to keep this medication out of reach of children. If you notice any skin reactions while using it, stop immediately and seek medical help.

In case of accidental swallowing or overdose, contact a Poison Control Center at 1-800-222-1222 or seek medical assistance right away, even if you don't see any symptoms. Quick action is crucial for both adults and children in these situations.

FAQ

What is ACETAMINOPHEN SUPPOSITORIES used for?

ACETAMINOPHEN SUPPOSITORIES are used as a pain reliever and fever reducer for children aged 3 to 6 years.

How does ACETAMINOPHEN work?

It reduces fever and relieves minor aches, pains, and headaches.

What is the recommended dosage for children aged 3 to 6 years?

You should use 1 suppository every 4 to 6 hours, with a maximum of 5 doses in 24 hours.

Are there any contraindications for using this product?

Do not use if you are allergic to acetaminophen or with any other drug containing acetaminophen.

What should I do if my child has liver disease?

Ask a doctor before using ACETAMINOPHEN SUPPOSITORIES if your child has liver disease.

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

If a skin reaction occurs, stop use and seek medical help right away.

What are the storage instructions for this product?

Store at 20-25°C (68-77°F) or in a cool place, and ensure the wrapper is intact before use.

What should I do in case of an overdose?

If swallowed or in case of overdose, get medical help or contact a Poison Control Center immediately.

Can I use this product for children under 3 years?

Do not use in children under 3 years unless directed by a doctor.

Packaging Info

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

Packaging configurations for Pain Reliever Fever Reducer.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen suppositories are formulated to provide pain relief and reduce fever. Each suppository contains 120 mg of acetaminophen and is intended for use in children aged 3 to 6 years. The product is supplied in a package containing 12 rectal suppositories, each delivering the specified dosage of 120 mg.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches, pains, and headaches.

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

Dosage and Administration

This product is not indicated for use in adults and should not be used in this population. For pediatric patients, the following dosing guidelines should be adhered to:

For children under 3 years of age, the product should not be used unless directed by a physician.

For children aged 3 to 6 years, the recommended dosage is 1 suppository administered every 4 to 6 hours, with a maximum of 5 doses within a 24-hour period.

Prior to administration, the wrapper should be removed. The suppository should be carefully inserted well up into the rectum to ensure proper placement. It is imperative to adhere strictly to the recommended dosing intervals and not exceed the maximum daily dosage.

Contraindications

Use is contraindicated in patients with a known allergy to acetaminophen. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

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 five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Acetaminophen may also trigger severe skin reactions, which can 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.

Healthcare providers should inquire about the child’s medical history prior to recommending this product, particularly if the child has a history of liver disease or is currently taking the anticoagulant warfarin. These conditions may necessitate additional monitoring or alternative treatment options.

In cases of accidental ingestion or suspected 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, as prompt intervention is essential for both adults and children.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: fever persists for more than three days (72 hours) or recurs, pain lasts longer than five days or worsens, new symptoms develop, or if there is redness or swelling in the area of pain. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen.

Patients may also experience severe skin reactions, which can 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.

This product is contraindicated in individuals with a known allergy to acetaminophen and should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the acetaminophen content of their medications are advised to consult a healthcare professional.

Prior to use, it is recommended that patients consult a physician if the child has liver disease or is taking the anticoagulant warfarin.

Patients should discontinue use and seek medical advice if fever persists for more than three days (72 hours), if pain lasts longer than five days or worsens, if new symptoms arise, or if there is redness or swelling in the area of pain, as these may indicate a serious underlying condition.

Drug Interactions

The concomitant use of warfarin, an anticoagulant, may lead to significant drug interactions that require careful monitoring and potential dosage adjustments.

When warfarin is administered alongside other medications, the risk of altered anticoagulant effects can increase, leading to either enhanced anticoagulation and a higher risk of bleeding or reduced efficacy and a risk of thrombosis.

Healthcare professionals should closely monitor the International Normalized Ratio (INR) in patients receiving warfarin, particularly when initiating or discontinuing other medications that may interact. Adjustments to the warfarin dosage may be necessary based on the INR results and the specific interacting agent involved.

It is essential to evaluate the patient's complete medication profile to identify any potential interactions and to ensure safe and effective use of warfarin therapy.

Packaging & NDC

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

Packaging configurations for Pain Reliever Fever Reducer.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For children aged 3 to 6 years, the recommended dosage is 1 suppository every 4 to 6 hours, with a maximum of 5 doses in a 24-hour period. Caution is advised when administering this medication to young children, and it is essential to follow the guidance of a healthcare provider.

Geriatric Use

Elderly patients may not have specific directions or warnings for adult use associated with this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the individual health status and potential comorbidities of elderly patients, as they may respond differently to treatment compared to younger populations.

Monitoring for efficacy and safety is advised, and healthcare providers should remain vigilant for any adverse effects that may arise during treatment in this demographic. Additionally, dosage adjustments may be necessary based on the clinical judgment of the healthcare provider, taking into account the unique pharmacokinetic and pharmacodynamic changes that can occur with aging.

Pregnancy

Pregnant patients should be aware that this product is not indicated for use in children under 3 years unless directed by a healthcare professional. There is no available data regarding the safety and efficacy of this product in pregnant women, and it does not contain specific directions or warnings for adult use.

Healthcare providers are advised to exercise caution and consult with a physician before recommending this product to pregnant patients, particularly if there are underlying health conditions such as liver disease or if the patient is taking anticoagulants like warfarin. The potential risks to fetal outcomes have not been established, and the absence of clinical data necessitates careful consideration of the benefits versus risks when prescribing this product to women of childbearing potential.

Lactation

There are no specific warnings or considerations regarding the use of acetaminophen suppositories in lactating mothers. The available data does not indicate any known effects on breastfed infants. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to lactation.

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 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 to mitigate the risk of hepatotoxicity.

Before administration, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or alternative therapies based on the patient's liver function status.

Overdosage

In the event of an overdose, immediate medical assistance is essential. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

It is important to note that prompt medical attention is crucial for both adults and children. Even in the absence of noticeable signs or symptoms, an overdose can have serious implications, and therefore, vigilance is necessary. Healthcare providers should ensure that patients and their families are aware of the potential risks associated with overdose and the importance of timely intervention.

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

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may include skin reddening, blisters, and rash. In cases where a skin reaction occurs, 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 if the medication is swallowed or in the event of an overdose. It is essential to emphasize that prompt medical attention is critical in cases of overdose, particularly for adults and children, even if no signs or symptoms are initially apparent. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in a tamper-evident configuration, with each suppository individually wrapped. It is essential to inspect the packaging prior to use; do not utilize any suppository if the printed wrapper is opened or damaged.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F) or in a cool place to ensure its integrity and effectiveness.

Additional Clinical Information

The route of administration for the medication is rectal, with a recommended dosage of one suppository every 4 to 6 hours, not exceeding five doses within a 24-hour period. Clinicians should advise patients to discontinue use and seek immediate medical assistance if a skin reaction occurs.

Patients should be counseled to keep the medication out of reach of children. In the event of accidental ingestion or overdose, it is crucial to obtain medical help or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Pain Reliever Fever Reducer, 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.