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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
January 8, 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
January 8, 2025
Manufacturer
Best Choice (Valu Merchandisers Company)
Registration number
ANDA074916
NDC roots
63941-760, 63941-761, 63941-762
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Children's Ibuprofen is an oral suspension that belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is specifically designed for children aged 2 to 11 years 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.

This medication contains 100 mg of ibuprofen per 5 mL and provides relief that can last up to 8 hours. It is alcohol-free and comes in a pleasant grape flavor, making it easier for children to take. Always ensure to read the product information before use to understand its intended purpose and proper usage.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or toothache. It is also effective in reducing fever, making you feel more comfortable when you're not feeling well.

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 it well. It's important to follow the dosing instructions carefully. You can find the right dose by checking the dosing chart, 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 medication—other devices may not provide the correct amount.

You should not give more than the recommended dose. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a single day. For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 and 35 pounds, the dose is 5 mL. As the weight increases, so does the dose: 7.5 mL for 4 to 5 years (36-47 pounds), 10 mL for 6 to 8 years (48-59 pounds), 12.5 mL for 9 to 10 years (60-71 pounds), and 15 mL for children aged 11 years and weighing 72-95 pounds. Always remember to follow these guidelines or consult your doctor if you have any questions.

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, especially in those who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, this medication can lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAIDs, especially if used in higher doses or for longer than recommended.

If your child experiences symptoms like faintness, vomiting blood, black or bloody stools, or persistent stomach pain, you should stop use and consult a doctor immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. It's important to seek medical advice if your child does not find relief within 24 hours, if symptoms worsen, or if new symptoms arise. Always consult a doctor before use if your child has a history of stomach issues, is dehydrated, or has any serious health conditions.

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 ibuprofen immediately and seek medical help.

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 a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, consult a doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 immediately.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, stomach pain, drowsiness (extreme tiredness), and headache.

If you suspect an overdose, seek immediate medical help or contact a poison control center right away. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no contraindications (situations where a drug should not be used) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the text does not highlight any special precautions you should take if you are pregnant.

While this information suggests that ibuprofen may not pose specific risks during pregnancy, it's always best to consult with your healthcare provider before taking any medication. They can provide personalized advice based on your health and pregnancy status.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If you are considering this medication for your child aged 2 to 11 years, it's important to follow the dosing guidelines carefully. For children under 2 years old and weighing less than 24 pounds, you should consult a doctor before use. For children aged 2 to 3 years who weigh between 24-35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 lbs), 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for an 11-year-old (72-95 lbs).

It's crucial not to use this medication in children under 3 years old unless directed by a doctor. Always consult a healthcare professional if your child has a history of stomach issues, is dehydrated, or has other serious health conditions. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop use immediately and seek medical advice. Remember to adhere to the recommended dosage and do not exceed four doses in a day.

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 know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, a common pain reliever, it can lead to serious stomach bleeding, especially if you're also using blood thinners (medications that prevent blood clots) or steroids. Additionally, using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen for longer than recommended can increase your risk of heart attack and stroke.

If your child is on a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider before giving them ibuprofen. Always discuss any medications or tests with your doctor to ensure safety and effectiveness.

Storage and Handling

To ensure the product remains effective and safe for use, store it at a temperature between 20° to 25°C (68° to 77°F). Before using, make sure to shake the bottle well. Always use the enclosed dosing cup for measuring; other devices may not provide the correct dosage. After opening, if you do not use the product, please discard it to maintain safety.

It's important to keep the product out of reach of children. To ensure child safety, replace the original bottle cap after each use. Additionally, check the printed neckband for any signs of tampering; do not use the product if it is broken or missing. 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. However, do not exceed four doses in a single day. If you experience stomach upset, it's advisable to take the medication with food or milk.

Make sure 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.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension (NSAID) used to relieve minor aches and pains and reduce fever in children.

What is the recommended dosage for Children's Ibuprofen?

The dosage is 100 mg per 5 mL. You should find the right dose based on your child's weight or age.

What age group can use Children's Ibuprofen?

Children's Ibuprofen is intended for children aged 2 to 11 years.

How long does the effect of Children's Ibuprofen last?

The effects of Children's Ibuprofen can last up to 8 hours.

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

If your child has a severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting, consult a doctor promptly.

Are there any warnings associated with Children's Ibuprofen?

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

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

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

Can I give Children's Ibuprofen to my child if they have had an allergic reaction to ibuprofen before?

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

How should I store Children's Ibuprofen?

Store Children's Ibuprofen between 20° to 25°C (68° to 77°F) and keep it out of reach of children.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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

Children's Ibuprofen is an oral suspension formulation classified as a nonsteroidal anti-inflammatory drug (NSAID). Each 5 mL dose contains 100 mg of ibuprofen, serving as an effective pain reliever and fever reducer. This product is alcohol-free and is indicated for use in children aged 2 to 11 years. The effects of the medication can last up to 8 hours. The suspension is presented in a grape flavor and is packaged in a 118 mL bottle.

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.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides specific recommendations:

  • For patients weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Healthcare professionals should ensure that patients do not exceed the maximum recommended doses and should advise caregivers to seek medical guidance if there are any uncertainties regarding dosing.

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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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.

The use of ibuprofen, an NSAID, carries a risk of severe stomach bleeding. This risk is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Healthcare professionals should be aware that 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 when the medication is used in excess of the recommended dosage or for extended periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be used for more than two days in such instances, nor should it be administered to children under three years of age unless specifically directed by a physician.

Healthcare providers should instruct caregivers to discontinue ibuprofen 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 seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen is associated with an increased risk of severe stomach bleeding, particularly 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. The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been 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 longer than directed.

Patients should be vigilant for signs of serious conditions. If a child experiences symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, medical attention should be sought immediately. Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant prompt consultation with a healthcare provider.

In clinical settings, it is advised that patients do not use ibuprofen for more than two days for sore throat symptoms, especially if accompanied by high fever, headache, nausea, or vomiting, without consulting a physician.

Patients should seek medical advice before using ibuprofen if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, children under a doctor's care for any serious condition or those taking other medications should consult a healthcare professional prior to use.

If symptoms do not improve within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. Redness or swelling in the painful area or the emergence of new symptoms should also prompt consultation with a healthcare provider.

Drug Interactions

Ibuprofen has several notable drug interactions that warrant careful consideration.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and to consider alternative pain management strategies when these medications are used together.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The use of ibuprofen, as with other NSAIDs, is associated with an elevated risk of cardiovascular events, including heart attack and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. Patients should be counseled on the importance of adhering to recommended dosages and durations of therapy.

Diuretics In pediatric patients, caution is advised when ibuprofen is administered alongside diuretics. It is recommended that healthcare providers consult with a physician to evaluate the appropriateness of ibuprofen use in this context, ensuring that potential risks are adequately managed.

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 aged 2 to 11 years may receive this medication with specific dosing recommendations based on weight. For children under 24 lbs, consultation with a doctor is advised. The dosing chart for children aged 2 to 11 years is as follows:

  • 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

It is important to note that this medication should not be used in children under 3 years of age unless directed by a doctor. Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, is dehydrated, or has other serious health conditions.

Monitoring for adverse effects is crucial; parents should be instructed to stop use and seek medical advice if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. Additionally, the total daily dosage should not exceed 4 doses, and caregivers must ensure that the medication is administered as directed.

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, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The text also does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available concerning the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of ibuprofen can lead to significant health risks and requires prompt medical intervention.

Symptoms of Overdose Healthcare professionals should be aware that symptoms of ibuprofen overdose may manifest as nausea, vomiting, stomach pain, drowsiness, and headache. These symptoms can vary in severity depending on the amount ingested and the individual’s health status.

Recommended Actions In the event of an overdose, it is crucial to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a poison control center for further guidance. Timely intervention is essential to mitigate potential complications associated with ibuprofen overdosage.

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 regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate occurrences of allergic reactions, which may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, there have been instances of stomach bleeding, 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).

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use. Reports have also highlighted severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, as potential indicators of serious underlying conditions.

Symptoms indicative of stomach bleeding may include feeling faint, vomiting blood, passing bloody or black stools, and experiencing stomach pain that does not improve. Furthermore, symptoms suggestive of heart problems or stroke may manifest as chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

Patients experiencing new symptoms during treatment are advised to discontinue use and seek consultation with a healthcare provider.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help 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 stop 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 stomach pain that does not improve. Furthermore, healthcare providers should emphasize the importance of discontinuing 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 using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is important for healthcare providers to recommend consulting a doctor before use if the stomach bleeding warning applies to the child, or if the child has a history of stomach issues such as heartburn. Additionally, 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 drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Healthcare providers should also recommend consulting a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic. Lastly, patients should be advised to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a container that requires careful handling and storage to ensure its integrity and safety. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Prior to use, the product must be shaken well to ensure proper mixing.

For dosing, it is imperative to use only the enclosed dosing cup; the use of any other dosing device is not recommended. After each use, the original bottle cap should be securely replaced to maintain child resistance. If the product is not used after opening, it should be discarded to prevent any potential safety issues.

To ensure safety, the product must be kept out of reach of children. Additionally, it is important to check the tamper-evident seal; the product should not be used if the printed neckband is broken or missing.

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. Patients are advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.