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Up and up 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 7, 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 7, 2025
Manufacturer
Target Corporation
Registration number
ANDA074937
NDC root
11673-685
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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If you are a consumer or patient please visit this version.

Drug Overview

Children’s Ibuprofen Oral Suspension is a medication designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and is available in a pleasant berry flavor.

This product is dye-free, alcohol-free, and non-staining, making it a suitable option for children. The effects of the medication can last up to 8 hours, providing effective relief when your child needs it most.

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 it. Start by shaking the bottle well before each use. To find the right dose, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age instead.

Make sure to use only the enclosed dosing cup, as other devices may not provide accurate measurements. Depending on your child's needs, you can repeat the dose every 6 to 8 hours, but remember not to give more than four doses in a single 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. If your child weighs under 24 pounds (under 2 years), consult a doctor for guidance. For children weighing between 24 and 95 pounds, the dosing amounts vary, so check the chart carefully to find the correct measurement.

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 this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

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 extended periods.

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 has a severe sore throat with high fever or if symptoms persist or worsen after a few days. Always talk to a healthcare professional before using ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

It's important to be aware of some serious warnings when using this medication. If you or your child have a known allergy to aspirin, be cautious, as this product can cause severe allergic reactions, including hives, swelling, or difficulty breathing. If any of these symptoms occur, stop using the medication and seek medical help immediately. Additionally, this medication can increase the risk of 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 ibuprofen.

You should also be mindful of the potential for heart problems, as using this medication can raise the risk of heart attack and stroke, particularly if taken 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 a high fever, headache, nausea, or vomiting, consult a doctor right away. Always check with a healthcare provider before use if your child has any underlying health conditions or is taking other medications.

If you suspect an overdose, contact a Poison Control Center or seek medical help immediately. Stop using the medication 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), or if their symptoms do not improve within 24 hours.

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. Specifically, you should avoid using ibuprofen during the later stages of pregnancy (the third trimester) because it can lead to serious complications, such as the premature closure of a vital blood vessel in the fetus. Additionally, using ibuprofen may pose risks to your baby's heart and overall health.

Before taking ibuprofen at any stage of your pregnancy, it's crucial to consult with your healthcare provider. They can provide guidance tailored to your specific situation and help you understand any necessary dosage modifications. Always prioritize your health and your baby's well-being by seeking professional advice.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. While ibuprofen can be helpful for pain relief, there is a possibility that it may pass into your breast milk. The effects of ibuprofen on nursing infants have not been thoroughly studied, so it's wise to be cautious.

Before taking ibuprofen, think about the benefits it may provide and weigh them against any potential risks to your baby. Your healthcare provider can help you make an informed decision that prioritizes both your health and your infant's well-being.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it 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, so it's best to follow the dosing chart provided by your healthcare provider. Always consult a doctor if your child has had an allergic reaction to ibuprofen or any other pain reliever, or if they are currently under medical care or taking other medications.

Make sure to keep this medication out of reach of children and do not use it for more than two days without medical advice. If you notice any signs of stomach bleeding, such as faintness, vomiting blood, or black stools, seek medical help immediately. Additionally, if your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if new symptoms appear, contact a healthcare professional.

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 the medication is appropriate and safe.

Always discuss any existing health conditions or medications you are taking, as older adults may have different needs and responses to treatments. Your healthcare provider can help determine the right dosage and monitor for any potential side effects.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis, or a history of stroke can complicate your situation. These factors may require careful monitoring and adjustments to your treatment plan to ensure your safety and well-being.

Make sure to discuss your kidney health with your healthcare provider, as they may need to adjust your medication dosages or monitor your kidney function more closely. Staying informed and proactive about your health can help you manage your conditions effectively.

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. If your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, can also heighten this risk.

To ensure your child's safety, always consult with a healthcare provider before starting ibuprofen or any other medication. This is especially crucial if your child is already taking other drugs, as interactions can lead to unexpected complications. Your healthcare provider can help you navigate these concerns effectively.

Storage and Handling

To ensure the best performance 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.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

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 Oral Suspension used for?

Children's Ibuprofen Oral Suspension is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What is the recommended dosage for Children's Ibuprofen?

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

How often can I give Children's Ibuprofen?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I use Children's Ibuprofen if my child is pregnant or breastfeeding?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated in late pregnancy. Nursing mothers should consult a doctor before use, as ibuprofen may be excreted in breast milk.

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and contact a doctor immediately.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen at 20-25°C (68-77°F) and do not freeze.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Up and up Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Up and up Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Children’s Ibuprofen Oral Suspension contains 100 mg of ibuprofen per 5 mL and is formulated as a non-steroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. This oral suspension is dye-free, alcohol-free, and non-staining, making it suitable for pediatric use. It is flavored with berry to enhance palatability for children aged 2 to 11 years. The effects of the medication can last up to 8 hours. Each package includes a dosage cup for accurate measurement, and the total volume of the suspension is 8 fluid ounces (237 mL).

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 (under 2 years), consultation with a physician is required prior to administration. For those weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. Patients weighing 36-47 lbs (4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (6-8 years) should be administered 10 mL. For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the recommended 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 maintain child resistance, the original bottle cap must be replaced securely after each use. It is imperative to adhere strictly to the recommended dosages and not exceed the directed amount.

Contraindications

Use is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger severe allergic responses. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery and medication interactions.

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 prolonged use or higher-than-recommended dosages.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. Healthcare professionals should be consulted promptly in such cases. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

Healthcare providers should advise parents to consult a doctor prior to use if any of the following conditions apply: the child has a history of stomach problems (such as heartburn), 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, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking diuretics.

Furthermore, it is advisable to consult a doctor or pharmacist before administering ibuprofen if the child is under medical care for any serious condition or is taking other medications.

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

Parents should discontinue use and contact a healthcare professional 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. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. 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 warning for the potential 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 are advised to adhere strictly to dosing instructions, as exceeding the recommended dosage or duration of use increases the likelihood of adverse effects.

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

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly.

In the event of symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, patients should discontinue use and consult a healthcare provider. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation.

Patients are advised to consult a healthcare professional before use if they have a history of stomach problems, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, it is recommended that patients under a doctor's care for serious conditions or those taking other medications seek guidance prior to using this product.

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 contact a healthcare provider. The presence of redness or swelling in the affected area or the emergence of new symptoms should also prompt a consultation with a healthcare professional.

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 pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Therefore, it is imperative to monitor these patients closely and consider alternative pain management strategies if they are on these medications.

Additionally, the risk of stomach bleeding is elevated when ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Healthcare providers should advise parents or guardians to consult a physician before administering ibuprofen if the child is taking any other medications, particularly those that may interact adversely.

Packaging & NDC

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

Packaging configurations for Up and up Ibuprofen.
Details

Pediatric Use

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

  • Under 24 lbs (under 2 years): consult a doctor

  • 24-35 lbs (2-3 years): 5 mL

  • 36-47 lbs (4-5 years): 7.5 mL

  • 48-59 lbs (6-8 years): 10 mL

  • 60-71 lbs (9-10 years): 12.5 mL

  • 72-95 lbs (11 years): 15 mL

Dosing may also be directed by a physician. It is important not to exceed 2 days of use in children under 3 years of age without medical advice.

Healthcare professionals should advise caregivers to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Prior to administration, caregivers should consult a doctor if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, is under a doctor's care for a serious condition, or is taking other medications.

When administering this product, it is recommended to give it with food or milk to minimize the risk of stomach upset. Caregivers should be instructed to discontinue use and consult a doctor if the child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if the child does not experience relief within the first 24 hours, 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, medical advice should be sought.

Geriatric Use

Elderly patients may not receive adequate guidance or warnings regarding the use of this product, as the labeling does not include specific directions or complete warnings for adult use. Healthcare providers should exercise caution when considering this product for geriatric patients, as the absence of detailed information may impact the safety and efficacy of treatment in this population. It is advisable to closely monitor elderly patients for any adverse effects and to consider alternative therapies that provide more comprehensive guidance for their use in older adults.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in late pregnancy (third trimester) due to the risk of premature closure of the ductus arteriosus in the fetus, which may lead to significant cardiovascular effects. The use of ibuprofen during pregnancy may pose risks to the fetus, and therefore, pregnant women should avoid using ibuprofen unless directed by a healthcare professional. It is essential for healthcare providers to be consulted before using ibuprofen during pregnancy, particularly in the later stages, to assess the potential risks and determine appropriate dosage modifications.

Lactation

Nursing mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to weigh the benefits against the potential risks when considering ibuprofen use while breastfeeding.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function, such as children with high blood pressure, heart disease, liver cirrhosis, or a history of stroke, should be evaluated for potential impacts on drug clearance. It is essential to assess renal function and adjust dosages accordingly to avoid adverse effects and ensure therapeutic efficacy. Regular monitoring of renal parameters is recommended to guide treatment decisions in this population.

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, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Careful consideration should be given to the overall health status of these patients, particularly if they also present with comorbidities such as high blood pressure, heart disease, or kidney disease.

Regular follow-up and reassessment of liver function are crucial to ensure the safe and effective use of the medication in this population.

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 support 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 ongoing safety monitoring.

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 crucial to inform patients that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

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. Furthermore, healthcare providers should emphasize the importance of stopping use and seeking medical advice 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 also be informed to stop use and consult a doctor 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 there is redness or swelling in the painful area, or if any new symptoms arise.

When administering this product, healthcare providers should recommend giving it with food or milk to mitigate potential stomach upset. It is advisable for patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning is applicable.

Patients should be encouraged to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea. Additionally, healthcare providers should recommend consulting a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Lastly, patients should be advised to discuss with a doctor or pharmacist before use if the child is taking a diuretic, is under medical care for any serious condition, or is currently taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment to maintain its efficacy. Special handling needs should be observed to prevent any damage or degradation during storage.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and the necessity of seeking immediate medical assistance or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients are instructed to use only the enclosed dosing cup for administration and to wash it after each use to ensure proper hygiene.

Drug Information (PDF)

This file contains official product information for Up and up 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 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.

Learn more in our Editorial Policy

Last AI update:

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.