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Up and up Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
October 26, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
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 2019
Label revision date
October 26, 2025
Manufacturer
Target Corporation
Registration number
ANDA076359
NDC root
11673-593
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

Children’s Ibuprofen Chewable Tablets are a pain reliever and fever reducer designed for children aged 2 to 11 years. This medication, which contains ibuprofen (a type of nonsteroidal anti-inflammatory drug or NSAID), helps to reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

These chewable tablets come in a pleasant orange flavor and can provide relief for up to 8 hours, making them a convenient option for managing your child's discomfort.

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, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

When taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, so do not exceed the recommended amount. To find the right dose, refer to the dosing chart based on your child's weight or age. If you need to give another dose, you can do so every 6 to 8 hours, but remember not to use it more than four times in a single day.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before giving any tablets. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 1 tablet. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, you can give them 1 and a half tablets. For children aged 6 to 8 years who weigh between 48 and 59 pounds, the dose is 2 tablets. If your child is 9 to 10 years old and weighs between 60 and 71 pounds, you can give them 2 and a half tablets. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 3 tablets. Always ensure you are following these guidelines to keep your child safe and healthy.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize safety by following these guidelines closely. If you have any concerns or questions about your child's health or medication, consult with a healthcare professional for personalized advice.

Side Effects

Using ibuprofen can lead to some serious side effects, so it's important to be aware of them. You may experience a severe allergic reaction, especially if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, ibuprofen can increase the risk of severe stomach bleeding, particularly if you have a history of stomach ulcers, are taking blood thinners or steroids, or are using other NSAIDs.

There is also a risk of heart attack and stroke associated with NSAIDs, which can be fatal, especially if used in higher doses or for longer than recommended. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems like chest pain or trouble breathing, seek medical attention immediately. Always consult your doctor if you have any underlying health conditions or are taking other medications before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop use and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if symptoms worsen or new symptoms appear, consult a doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, using ibuprofen during pregnancy, especially in the third trimester, is not recommended because it can pose risks to your baby, including potential cardiovascular issues.

Before taking ibuprofen, you should always consult your healthcare provider to discuss any pain relief options that are safe for you and your baby. Your health and the health of your fetus are paramount, so it's best to seek professional advice.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

When considering this medication for your child, it's important to note that it should not be used in children under 3 years of age unless directed by a doctor. For children aged 2 to 11 years, the dosage varies based on their weight. For example, children weighing 24-35 pounds (2-3 years) can take 1 tablet, while those weighing 72-95 pounds (11 years) can take 3 tablets. Always consult a doctor if your child has not been drinking fluids, has lost a lot of fluid from vomiting or diarrhea, or has a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic.

If your child does not experience relief within the first 24 hours, or if their fever or pain worsens or lasts more than 3 days, stop use and consult a doctor. Remember to keep this medication out of reach of children to ensure their 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 before starting the medication. 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 consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your doctor can help determine if this medication is safe for you and whether any adjustments to the dosage or monitoring are necessary. Always prioritize your health and communicate openly with your healthcare provider about your medical history.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these may also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness and safety.

When handling the product, be sure to check that the printed seal under the cap is intact. If the seal is broken or missing, do not use the product, as this may indicate that it is no longer safe to use. Always prioritize these storage and handling guidelines to ensure your safety and the product's reliability.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen Chewable Tablets used for?

Children's Ibuprofen Chewable Tablets are used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What age group can use Children's Ibuprofen Chewable Tablets?

This medication is intended for children aged 2 to 11 years.

How should I administer Children's Ibuprofen Chewable Tablets?

You should chew or crush the tablets completely before swallowing.

What is the maximum dosage for Children's Ibuprofen Chewable Tablets?

Do not use more than 4 times a day and repeat doses every 6-8 hours as needed.

Are there any contraindications for using Children's Ibuprofen?

Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or right before or after heart surgery.

What should I do if my child experiences signs of stomach bleeding?

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can I use Children's Ibuprofen during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester due to potential risks to the fetus.

What should I do if my child does not get relief from pain or fever?

If your child does not get any relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

What are the storage conditions for Children's Ibuprofen Chewable Tablets?

Store the tablets between 20-25°C (68-77°F) and do not use if the printed seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Up and up Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Up and up Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Up and up Childrens Ibuprofen, 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 conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. This product does not provide directions or complete warnings for adult use. Healthcare professionals should ensure that patients do not exceed the recommended dosage.

Dosing should be determined using the chart provided below, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure. If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed four doses.

Dosing Chart:

  • For patients weighing under 24 lb or under 2 years of age: Tablets - consult a doctor.

  • For patients weighing 24-35 lb or aged 2-3 years: Tablets - 1.

  • For patients weighing 36-47 lb or aged 4-5 years: Tablets - 1 ½.

  • For patients weighing 48-59 lb or aged 6-8 years: Tablets - 2.

  • For patients weighing 60-71 lb or aged 9-10 years: Tablets - 2 ½.

  • For patients weighing 72-95 lb or aged 11 years: Tablets - 3.

It is imperative to adhere strictly to these guidelines to ensure safe and effective use of the product.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of gastrointestinal complications.

NSAIDs, with the exception of aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Patients should be advised to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who exceed the recommended dosage or duration of use.

Patients should be advised to seek medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. The product should not be used for more than two days in such cases or in children under three years of age unless directed by a physician.

Common adverse reactions may include mouth or throat burning, which can be mitigated by administering the product with food or water. Patients are also advised to take the product with food or milk if stomach upset occurs.

It is essential for patients to consult a healthcare provider before using this product if they have a history of stomach problems, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, patients should inform their healthcare provider if they are under medical care for any serious condition or are taking other medications.

Patients should discontinue use and seek medical advice if they do not achieve relief within the first 24 hours, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Up and up Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Up and up Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age as follows:

  • Under 24 lb / Under 2 years: Consult a doctor

  • 24-35 lb / 2-3 years: 1 tablet

  • 36-47 lb / 4-5 years: 1 ½ tablets

  • 48-59 lb / 6-8 years: 2 tablets

  • 60-71 lb / 9-10 years: 2 ½ tablets

  • 72-95 lb / 11 years: 3 tablets

Healthcare professionals should advise caution in the following situations: if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea, a consultation with a doctor is recommended prior to use. Additionally, a doctor should be consulted if the child has a history of stomach problems, such as heartburn, or if there are pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Children with asthma or those taking diuretics should also seek medical advice before use.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, parents or caregivers should discontinue use and consult a doctor. It is important to keep this medication out of reach of children.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of ibuprofen during pregnancy may be associated with risks such as fetal cardiovascular effects, including premature closure of the ductus arteriosus. Pregnant women should consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, or liver cirrhosis, as these may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or the need for alternative therapeutic strategies. It is crucial to consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate treatment decisions.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical attention can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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

No postmarketing experience details are available in the insert text.

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.

Patients should be informed that they may experience burning sensations in the mouth or throat when taking the medication. To mitigate this, it is recommended that the medication be taken with food or water. Additionally, if patients experience stomach upset, they should take the medication with food or milk to help alleviate discomfort.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a 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 used if the printed seal under the cap is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Up and up Childrens Ibuprofen, 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 Up and up Childrens Ibuprofen, 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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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.