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Up and up Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2009
Label revision date
May 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2009
Label revision date
May 12, 2025
Manufacturer
Target Corporation
Registration number
ANDA074937
NDC root
11673-166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Children’s Ibuprofen is an oral suspension designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of medication that helps relieve pain and reduce fever) per 5 mL. This medication is effective in alleviating minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also helping to lower fever.

The product is alcohol-free and comes in a pleasant bubblegum flavor, making it easier for children to take. Each dose can provide relief for up to 8 hours, and a dosage cup is included for accurate measurement.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You’ll need to find the right dose based on the dosing chart provided, which considers both weight and age. If possible, use your child's weight for a more accurate dose; otherwise, you can use their age.

Make sure to use only the enclosed dosing cup to measure the medication, as other devices may not provide the correct amount. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times a day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for longer than recommended.

If your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, seek medical attention immediately. Other concerning symptoms include chest pain, difficulty breathing, weakness on one side of the body, or slurred speech. It's important to consult a doctor if your child does not find relief within 24 hours, if symptoms worsen, or if new symptoms arise. Always talk to a healthcare professional before using ibuprofen if your child has a history of stomach issues, is dehydrated, or has any serious health conditions.

Warnings and Precautions

It's important to be aware of some serious warnings when using ibuprofen. If you or your child have a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and skin issues like rash or blisters. If any of these occur, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

You should also be mindful of the risk of heart attack and stroke associated with NSAIDs, particularly if used in higher doses or for longer than recommended. If your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor right away. Before giving ibuprofen, check with a healthcare provider if your child has any underlying health issues, such as high blood pressure, kidney disease, or asthma, or if they are taking other medications.

If you suspect an overdose, contact a Poison Control Center or seek medical help immediately. Stop using ibuprofen and call your doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness on one side of the body), or if their condition does not improve within 24 hours. Always be vigilant for any new symptoms or worsening of fever or pain.

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 reach out for help. Your safety is the top priority, so getting prompt medical attention is essential.

Pregnancy Use

When considering the use of this product during pregnancy, it's important to note that there is no specific information available regarding its safety or use in pregnant individuals. This means that the product does not provide clear guidelines on whether it is safe or not during this time.

While the information does not mention any explicit risks or contraindications related to the use of ibuprofen (a common pain reliever) during pregnancy, it is always best to consult with your healthcare provider before taking any medication. They can help you weigh the potential benefits and risks based on your individual circumstances.

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 pass into your breast milk, and the effects of ibuprofen on nursing infants haven't been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your health and your baby's well-being are the top priorities, so staying informed and vigilant is key.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, if your child weighs under 24 pounds and is under 2 years old, consult a doctor before giving any dose. For children aged 2 to 3 years weighing between 24-35 pounds, the recommended dose is 5 mL, while those aged 4 to 5 years and weighing 36-47 pounds should receive 7.5 mL. As the weight increases, so does the dosage, reaching up to 15 mL for an 11-year-old weighing 72-95 pounds.

It's important to keep this medication out of reach of children and to seek immediate medical help or contact a Poison Control Center (1-800-222-1222) in case of an overdose. Always consult a doctor before use if your child is taking blood thinners, other NSAIDs (like aspirin or ibuprofen), or is under care for a serious condition. If your child shows any signs of stomach bleeding, heart problems, or if their symptoms worsen or do not improve within a day, stop use and consult a doctor.

Geriatric Use

When considering this product, it's important to note that it does not provide specific directions or warnings for adult use, including older adults. If you or a loved one has high blood pressure, heart disease, liver cirrhosis (a severe liver condition), kidney disease, or has experienced a stroke, it's crucial to consult with a healthcare professional before using this product. These conditions can affect how medications work in your body, and a doctor can help determine the safest options for your health needs. Always prioritize safety and seek guidance tailored to your individual circumstances.

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 based on your kidney health. Always prioritize your safety and well-being by discussing your medical history with your healthcare provider.

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 the treatment.

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

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Additionally, if your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if your child is using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

To ensure your child's safety, always consult with a healthcare provider before starting ibuprofen or any other medication. Discussing all medications your child is taking, including over-the-counter drugs, is crucial to avoid potential interactions and complications.

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). It's important to keep it away from freezing temperatures, as freezing can damage the product. Before using, check that the printed neckband is intact; do not use the product if the neckband is broken or missing, as this could compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup for accurate measurement, and make sure to wash it after each use.

It's important to keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that acts as a pain reliever and fever reducer, containing 100 mg of ibuprofen per 5 mL.

What age group is Children's Ibuprofen suitable for?

It is suitable for children aged 2 to 11 years.

What are the main uses of Children's Ibuprofen?

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

How should I dose Children's Ibuprofen?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight and age. Do not exceed the recommended dose.

What should I do if my child experiences stomach upset?

If stomach upset occurs, give Children's Ibuprofen with food or milk.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe allergic reactions and stomach bleeding, especially if your child has certain medical conditions or is taking other medications.

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.

Can I use Children's Ibuprofen if my child has had an allergic reaction to ibuprofen before?

No, do not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is it safe to use Children's Ibuprofen during pregnancy?

The product does not contain specific information regarding use during pregnancy, so consult a doctor before use.

What flavor does Children's Ibuprofen come in?

It comes in a bubblegum flavor.

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

Children’s Ibuprofen is an oral suspension formulated for pediatric use in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The product is alcohol-free and features a bubblegum flavor to enhance palatability. The suspension is packaged in an 8 FL OZ (237 mL) bottle and includes a dosage cup for accurate administration. The effects of the medication can last up to 8 hours. This formulation is comparable to the active ingredient found in Children’s Motrin® Bubble Gum Flavor.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a physician for the appropriate dose. For patients weighing between 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (ages 4-5 years), the dose is 7.5 mL. Patients weighing 48-59 lbs (ages 6-8 years) should receive 10 mL, while those weighing 60-71 lbs (ages 9-10 years) should be administered 12.5 mL. For patients weighing 72-95 lbs (age 11 years), the dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly to ensure hygiene. It is crucial to replace the original bottle cap after use to maintain child resistance and prevent accidental ingestion. Healthcare professionals should emphasize that no more than the directed dose should be administered.

Contraindications

Use is contraindicated in children with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can 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 children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or are exceeding the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or prolonged use.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of this medication should not exceed two days, nor should it be administered to children under three years of age unless directed by a healthcare provider.

Healthcare professionals should advise caregivers to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous gastrointestinal issues such as heartburn, adverse reactions to pain relievers or fever reducers, inadequate fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, history of stroke, asthma, or if the child is taking diuretics.

Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the child is under medical care for any serious condition or is currently taking other medications.

In the event of an overdose, immediate medical attention should be sought, or contact the Poison Control Center at 1-800-222-1222.

Caregivers should discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought without delay.

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, or those using other NSAIDs, including aspirin and naproxen. Patients should be advised to adhere strictly to dosing instructions, as prolonged use or exceeding the recommended dosage increases the likelihood of such adverse effects.

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 closely monitored for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting, which may indicate a serious underlying issue. It is recommended that patients consult a healthcare provider promptly if these symptoms occur or if the product is used for more than two days, especially in children under three years of age.

Patients should discontinue use and seek medical attention if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation with a healthcare provider.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also important for patients under a doctor's care for any serious condition or those taking other medications to seek guidance from a healthcare professional prior to use.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to patients with such allergies.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen, especially those who are concurrently taking anticoagulants, steroids, or other NSAIDs. Consultation with a physician is recommended if the patient is on any additional medications to ensure safe and effective use of ibuprofen.

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: for those under 24 lbs (under 2 years), consultation with a doctor is advised; for 24-35 lbs (2-3 years), the recommended dose is 5 mL; for 36-47 lbs (4-5 years), 7.5 mL; for 48-59 lbs (6-8 years), 10 mL; for 60-71 lbs (9-10 years), 12.5 mL; and for 72-95 lbs (11 years), 15 mL.

The medication should not be used for more than 2 days in children under 3 years of age unless directed by a healthcare professional. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact a Poison Control Center at 1-800-222-1222.

Before administering this medication, it is important to consult a doctor if the child is taking anticoagulants or steroid drugs, other NSAIDs (such as aspirin, ibuprofen, or naproxen), or is under medical care for any serious condition.

Parents or caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), symptoms of heart problems or stroke (e.g., chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling), does not experience relief within the first 24 hours of treatment, if fever or pain worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Geriatric Use

Elderly patients may present with comorbidities such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, which can complicate the management of their health conditions. It is important to note that this product does not contain specific directions or complete warnings for adult use, including geriatric populations.

Healthcare providers should exercise caution when prescribing this product to elderly patients, considering the potential for altered pharmacokinetics and increased sensitivity to adverse effects. Close monitoring of these patients is recommended to ensure safety and efficacy, and dosage adjustments may be necessary based on individual health status and response to treatment.

Pregnancy

The product does not contain specific information regarding its use during pregnancy. Currently, there are no explicit statements about contraindications or risks associated with the use of ibuprofen during pregnancy. Healthcare professionals should consider the lack of data when advising pregnant patients and weigh the potential benefits against any unknown risks. It is advisable to exercise caution and to discuss the use of this product with women of childbearing potential who are pregnant or planning to become pregnant.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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, liver cirrhosis, or a history of stroke, as these factors 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 medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach for those with hepatic impairment.

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 help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation 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 assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and should be considered when evaluating the safety profile of the product.

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. It is recommended to administer the medication with food or milk if the child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, healthcare providers should inform patients to stop use and seek medical attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should be made aware that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a doctor.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following conditions apply: the child has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients should be advised to seek medical advice if the child has asthma or is taking a diuretic.

Finally, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is currently under medical care for any serious condition or is taking any other medications.

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). Freezing the product is strictly prohibited, as it may compromise 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 tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with the option to repeat doses every 6-8 hours as needed, not exceeding four doses in a 24-hour period. It is recommended to take the medication with food or milk if stomach upset occurs.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients should use only the enclosed dosing cup for administration and ensure it is washed after each use.

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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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.