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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 2017
Label revision date
August 6, 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 2017
Label revision date
August 6, 2025
Manufacturer
EQUATE (WAL-MART STORES, INC.)
Registration number
ANDA209207
NDC root
49035-693
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen is a medication that comes in an oral suspension form, specifically designed for children aged 2 to 11 years. It is a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen is effective in reducing fever and provides relief that can last up to 8 hours.

This particular formulation is dye-free and has a pleasant berry flavor, making it easier for children to take. It is comparable to Children's Motrin® in terms of its active ingredient, ensuring that you can trust its effectiveness for your child's discomfort.

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.

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to follow the dosing instructions carefully. You should find the right dose based on the dosing chart provided, which considers both weight and age. If possible, use your child's weight to determine the dose; if not, you can use their age instead. Always use the enclosed dosing cup to measure the dose accurately—do not use any other device.

For children weighing under 24 pounds or younger than 2 years, it's best to consult a doctor for the appropriate dose. For children weighing between 24 and 35 pounds (ages 2-3 years), the dose is 5 mL. If your child weighs between 36 and 47 pounds (ages 4-5 years), the dose is 7.5 mL. For those weighing 48 to 59 pounds (ages 6-8 years), the dose is 10 mL, and for children weighing 60 to 71 pounds (ages 9-10 years), the dose is 12.5 mL. Finally, if your child weighs between 72 and 95 pounds (age 11 years), the dose is 15 mL.

You can repeat the dose every 6 to 8 hours if needed, but do not exceed 4 doses in a single day. Always remember to stick to the recommended amounts to ensure safety.

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 (asthma), 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.

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 severe sore throat symptoms, stomach bleeding signs (like faintness, vomiting blood, or black stools), or symptoms of heart problems (such as chest pain or trouble breathing), seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, 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, 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 are under three years old. 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.

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester (the final three months of pregnancy). Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may pose risks to your baby, including potential heart and kidney issues.

Before taking ibuprofen, you should always consult your healthcare provider, particularly if you are in the later stages of your pregnancy. They can help you understand the risks and suggest safer alternatives for managing pain or inflammation during this time.

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 can pass into your breast milk. The effects of ibuprofen on nursing infants haven't been thoroughly studied, so it's wise to be cautious.

If you do take ibuprofen while breastfeeding, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when giving medication to children. For children under 2 years old, you should only use this medication if a doctor specifically advises it. If your child is between 2 and 3 years old and weighs between 24-35 pounds, the recommended dose is 5 mL. For those aged 4-5 years (36-47 lbs), the dose increases to 7.5 mL, while children aged 6-8 years (48-59 lbs) should receive 10 mL. For kids aged 9-10 years (60-71 lbs), the dose is 12.5 mL, and for an 11-year-old (72-95 lbs), the recommended dose is 15 mL.

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or has lost a lot of fluids from vomiting or diarrhea. Make sure not to exceed 4 doses in a day, and if your child doesn’t feel better within 24 hours, reach out to a doctor. Additionally, do not use this medication for more than 3 days for fever or pain without medical advice. Keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

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 will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these 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 cautious when giving ibuprofen to your child, especially if they are also taking other medications. Ibuprofen can increase the risk of severe stomach bleeding, particularly when combined with blood thinners (medications that prevent blood clots) or steroids. Additionally, if your child is taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, the risk of stomach bleeding is even higher.

Before giving ibuprofen, make sure to consult with your healthcare provider if your child is on a diuretic (a medication that helps remove excess fluid from the body) or any other drugs. Always check with a doctor or pharmacist to ensure that it’s safe to use ibuprofen alongside any other medications your child may be taking. This way, you can help protect their health and avoid potential complications.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This range is considered a controlled room temperature, which helps maintain the product's quality. Always check the carton before use; do not use the product if the carton is opened or if the bottle wrap marked "SEALED FOR SAFETY" is broken or missing.

Additionally, make sure to look at the bottom panel of the carton for the lot number and expiration date, as this information is crucial for tracking the product's safety and effectiveness. Proper handling and storage are key to ensuring you get the best results from 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 4 doses in a day. If you experience stomach upset, it's advisable to take the medication with food or milk.

It's important to monitor for any serious side effects. If a child shows signs of stomach bleeding, symptoms of heart problems or stroke, does not feel better within 24 hours, or if fever or pain worsens or lasts more than 3 days, you should stop using the medication and consult a doctor. Additionally, seek medical advice if there is redness or swelling in the painful area or if any new symptoms develop.

FAQ

What is ibuprofen used for?

Ibuprofen 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?

The dosage varies by weight and age. For example, children aged 2-3 years (24-35 lbs) should take 5 mL, while those aged 11 years (72-95 lbs) should take 15 mL.

How often can ibuprofen be given?

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

Are there any warnings associated with ibuprofen?

Yes, ibuprofen 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 ibuprofen be used during pregnancy?

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

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or if symptoms do not improve within 24 hours.

How should ibuprofen be stored?

Store ibuprofen at 20° to 25°C (68° to 77°F) and do not use if the carton is opened or if the safety seal is broken.

Is ibuprofen safe for nursing mothers?

Nursing mothers should consult a doctor before using ibuprofen, as it may be excreted in breast milk and its effects on nursing infants are not well studied.

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

NDC 49035-693-09 equate™ children's IBUPROFEN Oral Suspension, USP is 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 dye-free and features a berry flavor to enhance palatability. The suspension is packaged in a 4 FL OZ (120 mL) bottle and provides relief that lasts up to 8 hours. This formulation is comparable to the active ingredient found in Children's Motrin® Dye-Free Berry 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 pounds or under 2 years of age, it is advised to consult a physician for the appropriate dosage. For patients weighing between 24 and 35 pounds (ages 2 to 3 years), the recommended dose is 5 mL. For those weighing 36 to 47 pounds (ages 4 to 5 years), the dose is 7.5 mL. Patients weighing 48 to 59 pounds (ages 6 to 8 years) should receive 10 mL, while those weighing 60 to 71 pounds (ages 9 to 10 years) should be administered 12.5 mL. Finally, for patients weighing 72 to 95 pounds (age 11 years), the dose is 15 mL.

Dosing may be repeated every 6 to 8 hours as needed, but it is crucial not to exceed 4 doses in a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

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 a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate consultation with a healthcare provider is advised. Ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a physician.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice 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 suggestive 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, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

In the event of an overdose, it is critical to obtain emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, particularly those related to allergic responses, gastrointestinal complications, and cardiovascular risks.

Severe allergic reactions may occur, especially 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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant 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 gastrointestinal complications.

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 recommended duration or dosage.

Patients should seek immediate medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. It is recommended that ibuprofen not be used for more than two days in such cases or in children under three years of age unless directed by a healthcare provider.

Parents and caregivers should discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having 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 evaluation. Furthermore, if the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought.

It is crucial to consult a healthcare professional before administering ibuprofen if the child has a history of stomach issues, is dehydrated, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has experienced a stroke. Additionally, caution is advised for children with asthma or those taking diuretics. Parents should also inform their healthcare provider if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has been associated with significant drug interactions that may increase the risk of adverse effects, particularly gastrointestinal bleeding.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may lead to an increased risk of severe stomach bleeding. It is advisable to monitor patients closely for signs of gastrointestinal distress and consider dosage adjustments or alternative therapies as necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The risk of stomach bleeding is further heightened in pediatric patients who are concurrently taking other NSAIDs, including aspirin, naproxen, or any other prescription or nonprescription NSAID. Careful evaluation of the patient's medication regimen is recommended to avoid polypharmacy and potential cumulative effects.

Diuretics For patients on diuretics, consultation with a healthcare provider is recommended prior to the use of ibuprofen. This is to ensure appropriate management and monitoring of renal function and electrolyte balance, as the combination may necessitate dosage adjustments.

General Recommendations Patients or caregivers should be advised to consult a healthcare professional or pharmacist before administering ibuprofen if the child is taking any other medications. This precaution helps to mitigate the risk of adverse interactions and ensures safe therapeutic practices.

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 2 years of age should not use this medication unless directed by a doctor. For children aged 2-3 years (24-35 lbs), the recommended dose is 5 mL; for those aged 4-5 years (36-47 lbs), the dose is 7.5 mL; for children aged 6-8 years (48-59 lbs), the recommended dose is 10 mL; for children aged 9-10 years (60-71 lbs), the dose is 12.5 mL; and for children aged 11 years (72-95 lbs), the recommended dose is 15 mL.

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, is taking other medications, or has experienced significant fluid loss due to vomiting or diarrhea. The medication should not be administered more than 4 times a day. If the child does not experience relief within the first 24 hours of treatment, a doctor should be consulted. Additionally, the medication should not be used for more than 3 days for fever or pain without consulting a doctor.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with risks to the fetus, including potential cardiovascular effects and renal impairment.

Pregnant women should consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy. It is essential for healthcare professionals to weigh the potential risks and benefits when considering the use of ibuprofen in pregnant patients.

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 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, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to identify any potential adverse effects related to liver function.

Additionally, patients with a history of significant comorbidities such as high blood pressure, heart disease, kidney disease, or a history of stroke should be monitored closely, as these conditions may further complicate the management of their 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 symptoms may vary depending on the substance involved. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate appropriate management procedures based on the clinical presentation and the specific agent involved in the overdose.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to implement standard protocols for overdose management, including the administration of activated charcoal if indicated and the provision of symptomatic treatment as required.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate the occurrence of allergic reactions, which may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been documented, particularly in patients with a history of stomach ulcers or bleeding disorders, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Severe allergic reactions have been noted, especially in individuals with a prior history of aspirin allergy. Furthermore, cases of gastrointestinal bleeding have been reported, particularly among patients with pre-existing conditions or those taking medications that may elevate the risk of bleeding. There have also been reports of cardiovascular events, including heart attack and stroke, in patients using NSAIDs, particularly at higher doses or for extended durations.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed 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, it is important to emphasize that this medication should not be administered right before or after heart surgery.

Healthcare providers should counsel patients 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, patients should be advised 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 also be informed that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should consult a doctor. Any presence of redness or swelling in the painful area, or the emergence of new symptoms, should prompt a discussion with a healthcare provider.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is essential for healthcare providers to recommend consulting a doctor before use if the stomach bleeding warning applies to the child, or if there is a history of stomach problems such as heartburn.

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

Finally, patients should be advised to consult a doctor or pharmacist before use if the child is taking a diuretic or is under a doctor's care for any serious condition, as well as before using this medication if the child is taking any other drugs.

Storage and Handling

The product is supplied in a carton that contains a bottle, with specific handling instructions to ensure safety and efficacy. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

Healthcare professionals should not use the product if the carton has been opened or if the bottle wrap, which is imprinted with "SEALED FOR SAFETY," is broken or missing. For traceability, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6 to 8 hours as needed, not to exceed four doses in a 24-hour period. Patients should be advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel patients to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, symptoms indicative of heart problems or stroke, fails to achieve relief within the first 24 hours, experiences worsening fever or pain lasting more than three days, shows redness or swelling in the affected area, or develops any new symptoms.

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

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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.