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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 1999
Label revision date
October 11, 2023
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 1999
Label revision date
October 11, 2023
Manufacturer
Walgreen Company
Registration number
ANDA074937
NDC root
0363-0897
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Children’s Ibuprofen 100 is a liquid medication that contains ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) in a concentration of 100 mg per 5 mL. It is designed to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache, while also helping to reduce fever. This medication is suitable for children aged 2 to 11 years and comes in a pleasant berry flavor.

The effects of Children’s Ibuprofen 100 can last for up to 8 hours, making it a convenient option for managing discomfort and fever in children. It is available in bottles of 2 to 4 fluid ounces (118 mL) and 8 fluid ounces (237 mL), and it is alcohol-free, ensuring a safer choice for young patients.

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 note that it does not 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 should find the right dose by referring to the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age instead.

When measuring the dose, always use the enclosed dosing cup, as other devices may not provide accurate measurements. For children, the recommended doses vary based on weight, with specific amounts for different age groups. If necessary, you can repeat the dose every 6 to 8 hours, but do not use it more than four times a day. After each use, remember to wash the dosing cup and securely replace the original bottle cap to keep it child-resistant.

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or 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.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always discuss with a healthcare provider before giving ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication 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, or if you experience symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, 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 their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get 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.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help if you think an overdose has occurred.

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 third trimester (the last three months of pregnancy) because it can lead to serious complications, such as the premature closure of a vital blood vessel in the fetus. Additionally, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy may increase the risk of cardiovascular issues for the developing baby.

Before taking ibuprofen at any stage of your pregnancy, it’s crucial to consult with your healthcare provider. They can help you understand the risks and determine the best options for managing any discomfort you may experience.

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 healthcare provider can help guide you on the best choices for you and your child.

Pediatric Use

When considering medication for your child, it's important to follow specific guidelines based on their age and weight. For children under 3 years old, you should only use this medication if directed by a doctor. For dosing, the recommendations are as follows: if your child weighs under 24 lbs, consult a doctor; for those weighing 24-35 lbs (ages 2-3), the dose is 5 mL; for 36-47 lbs (ages 4-5), it's 7.5 mL; for 48-59 lbs (ages 6-8), it's 10 mL; for 60-71 lbs (ages 9-10), it's 12.5 mL; and for 72-95 lbs (age 11), it's 15 mL. Always use the dosing cup provided and do not exceed the recommended amount.

Be cautious and consult a doctor if your child has a severe sore throat, especially if accompanied by a high fever, headache, nausea, or vomiting. If your child has a history of stomach issues, high blood pressure, heart disease, liver or kidney problems, or if they are taking certain medications, it's essential to seek medical advice before use. Watch for any signs that require stopping the medication, such as stomach bleeding, symptoms of heart problems or stroke, lack of relief after 24 hours, worsening fever or pain, or any new symptoms.

Geriatric Use

You can feel reassured that there are no specific concerns regarding the use of Ibuprofen Children's suspension for older adults. The information available does not indicate any need for dosage adjustments or special safety precautions for elderly patients. This means that, in general, you can use this medication without worrying about unique risks associated with age. However, as always, it's a good idea to consult with a healthcare provider before starting any new medication, especially if there are other health conditions or medications involved.

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 will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a 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 to receive the best care possible.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you are using blood thinners (anticoagulants) or steroid drugs. These medications can interact with other treatments, potentially affecting how well they work or increasing the risk of side effects. Additionally, if you are taking nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin, ibuprofen, or naproxen, you should also discuss this with your provider, as these can have similar interactions.

While there are no specific laboratory test interactions noted, keeping your healthcare provider informed about all your medications ensures they can monitor your health effectively and make the best decisions for your care. Always prioritize open communication about your medications and any changes in your health.

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 use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its effectiveness.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. It's important to keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

FAQ

What is Children's Ibuprofen 100?

Children's Ibuprofen 100 is an oral suspension containing 100 mg of ibuprofen per 5 mL, used as a pain reliever and fever reducer for children aged 2 to 11 years.

How does Children's Ibuprofen 100 work?

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

What are the dosing instructions for Children's Ibuprofen 100?

Use the enclosed dosing cup to measure the dose based on the child's weight or age, and do not exceed 4 doses in a day.

What should I do if my child experiences side effects?

If your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours, stop use and consult a doctor immediately.

Is it safe to use Children's Ibuprofen 100 during pregnancy?

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

Can I give Children's Ibuprofen 100 to my child if they have allergies?

Do not use this product if your child has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What should I do if my child has a severe sore throat?

Consult a doctor if your child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

How should I store Children's Ibuprofen 100?

Store at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

What are the signs of a serious allergic reaction?

Signs may include hives, facial swelling, asthma, shock, skin reddening, rash, or blisters. Seek medical help immediately if these occur.

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 Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is a twin pack of Children's Ibuprofen Oral Suspension, containing 100 mg of ibuprofen per 5 mL. It is formulated as a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. The suspension is alcohol-free and is suitable for children aged 2 to 11 years. Each bottle contains 2 to 4 fluid ounces (118 mL), with a total volume of 8 fluid ounces (237 mL) across the twin pack. The product features a berry flavor and is comparable to the active ingredient in Children’s Motrin®. The effects of the medication may last up to 8 hours. New warnings should be reviewed prior to use.

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

For children weighing under 24 lbs (under 2 years), it is advised to consult a doctor for appropriate dosing. For children weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Children weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. For children 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 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap should be replaced securely after each use. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

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 is associated with an increased risk of severe stomach bleeding. The likelihood of such an event 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 may further elevate this risk.

NSAIDs, excluding aspirin, are also linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified 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, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. Furthermore, ibuprofen should not be administered for more than two days or to children under three years of age unless specifically directed by a healthcare provider.

Patients should be instructed 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.

In cases of overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

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 potential severe stomach bleeding. The risk of this serious adverse reaction 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. Additionally, prolonged use or exceeding the recommended dosage may increase the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified with higher doses or extended duration of use.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation. It is advised not to use this product for more than two days or in children under three years of age unless directed by a healthcare professional.

Patients should discontinue use and seek medical advice if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also necessitate immediate medical attention. Furthermore, if a child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended.

Before using this product, it is important to consult a healthcare provider if the stomach bleeding warning applies, if there is a history of stomach issues such as heartburn, or if the child has experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for children who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing conditions such as 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 prior to use.

Lastly, it is recommended to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience increased risks of bleeding when co-administered with this drug. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

Additionally, the concurrent use of this drug with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may enhance the risk of gastrointestinal adverse effects. Careful monitoring for gastrointestinal symptoms is recommended, and dosage adjustments may be warranted based on the clinical scenario.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For dosing, the following age and weight recommendations apply: for children under 24 lbs (under 2 years), consult a doctor; for those weighing 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. It is advised to use weight for dosing when possible; otherwise, age may be used. Only the enclosed dosing cup should be utilized, and doses may be repeated every 6-8 hours, not exceeding 4 times a day.

Healthcare professionals should be aware of specific warnings. Consultation with a doctor is necessary if the child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting. The risk of stomach bleeding increases in children with a history of stomach issues, such as heartburn or ulcers. Additionally, if the child has lost significant fluid due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke, a doctor should be consulted prior to use. Children with asthma or those taking diuretics also require medical advice before using this medication.

Parents and caregivers should monitor for signs that necessitate discontinuation of use. These include symptoms of stomach bleeding (e.g., feeling faint, vomiting blood, black or bloody stools, persistent stomach pain), signs of heart problems or stroke (e.g., chest pain, difficulty breathing, weakness on one side of the body, slurred speech, leg swelling), lack of relief within the first 24 hours, worsening fever or pain lasting more than 3 days, or the presence of redness or swelling in the affected area, as well as any new symptoms.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Ibuprofen Children's suspension. Therefore, standard dosing guidelines may be applicable to this population. However, healthcare providers should remain vigilant and monitor for any potential adverse effects, as individual responses to medication can vary among geriatric patients.

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. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with an increased risk of fetal cardiovascular effects.

Pregnant women are advised to consult a healthcare provider before using ibuprofen, particularly during the third trimester, to discuss potential risks and alternative treatment options.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. 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 prior to 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 course to ensure safety and efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition, as this may impact the overall treatment plan. Regular assessment of blood pressure and cardiovascular status is also advised, particularly in patients with concurrent conditions such as heart disease or kidney disease.

Overall, careful consideration and monitoring are crucial for patients with hepatic impairment to optimize therapeutic outcomes while minimizing risks.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms 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 and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and 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 are included for informational purposes.

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 configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, ensuring that the integrity of the packaging is intact before use.

Additional Clinical Information

The medication is administered orally, with the option to repeat doses every 6 to 8 hours as needed, not exceeding four doses in a 24-hour period. Clinicians should advise 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.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 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.