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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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 2018
Label revision date
November 14, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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 2018
Label revision date
November 14, 2018
Manufacturer
WinCo Foods, LLC
Registration number
ANDA209207
NDC root
67091-321
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

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

This medication is alcohol-free and dye-free, providing a gentle option for managing discomfort in young children. Its effects can last for up to 8 hours, offering extended relief when needed.

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’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 are pregnant, although you should always consult with your healthcare provider before taking any medication.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. It's important to use only the enclosed dosing cup to measure your dose—other devices may not provide the correct amount. To find the right dose, refer to the dosing chart based on your child's weight or age. If you’re unsure, it’s best to consult a doctor, especially for children under 2 years old.

Once you have the correct dose, you can repeat it every 6 to 8 hours if needed, but remember not to exceed 4 doses in a single day. For example, if your child weighs between 24 and 35 pounds, the dose is 5 mL. For those weighing 36 to 47 pounds, the dose increases to 7.5 mL, and so on, up to 15 mL for children weighing 72 to 95 pounds. Always follow the chart closely to ensure safety and effectiveness.

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 fatal, particularly if used in higher doses or for extended periods. If your child experiences severe or persistent sore throat, high fever, or any signs of stomach bleeding (such as faintness, vomiting blood, or black stools), or symptoms of heart problems (like 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 has other serious health conditions before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended. If your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. It’s important not to use ibuprofen for more than two days in these cases or for children under three years old unless directed by a healthcare professional.

If you suspect an overdose, contact a Poison Control Center immediately at 1-800-222-1222. You should also stop using ibuprofen and consult a doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness on one side of the body), or if their condition does not improve within 24 hours. Additionally, seek medical advice if fever or pain worsens after three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

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, particularly in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular issues.

Before taking ibuprofen, you should always consult your healthcare provider. They can provide guidance on whether you need to adjust your dosage or consider alternative pain relief options that are safer during pregnancy. Your health and the health of your baby are the top priority, so make sure to discuss any medications with your doctor.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations regarding the use of ibuprofen mentioned in the drug insert. This means that, based on the available information, ibuprofen is generally considered safe for nursing mothers.

However, as with any medication, it's always a good idea to consult with your healthcare provider before taking ibuprofen while breastfeeding, especially if you have any concerns about its effects on your milk production or your baby.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs under 24 pounds, consult a doctor before use. For those weighing 24-35 pounds, the recommended dose is 5 mL, while children weighing 36-47 pounds should receive 7.5 mL. As the weight increases, so does the dosage, reaching 15 mL for children who weigh between 72-95 pounds.

Before giving this medication, consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions. If your child shows any signs of stomach bleeding, symptoms of heart problems or stroke, or does not feel better within 24 hours, stop using the medication and seek medical advice. Always keep the medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Geriatric Use

When it comes to using this medication in older adults, the insert does not provide specific guidelines or recommendations. This means there are no particular age-related dosage adjustments, safety concerns, or special precautions outlined for elderly patients.

As you consider treatment options, it's always a good idea to discuss any concerns with your healthcare provider, especially if you or a loved one is an older adult. They can help ensure that the medication is appropriate and safe based on individual health needs.

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 may suggest necessary adjustments to your treatment plan. 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 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.

Drug Interactions

It's important to be aware of potential interactions when your child is taking medications. For instance, if your child is allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases significantly. The same applies if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with your healthcare provider if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and any lab tests with your doctor is crucial to ensure your child's safety and well-being.

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 important for tracking and safety. Proper handling and storage 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 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 help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension pain reliever and fever reducer that contains 100 mg of ibuprofen per 5 mL. It is alcohol-free, dye-free, and has a berry flavor.

What age group can use Children's Ibuprofen?

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

How does Children's Ibuprofen work?

Children's Ibuprofen relieves minor aches and pains from conditions like the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

What is the dosing schedule for Children's Ibuprofen?

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

How should I determine the right dose for my child?

Use the dosing chart based on your child's weight or age, and always use the enclosed dosing cup.

What should I do if my child has a severe allergic reaction?

If your child experiences symptoms like hives, facial swelling, or difficulty breathing, stop use immediately and seek medical help.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause stomach bleeding, increase the risk of heart attack and stroke, and should not be used if your child has had an allergic reaction to ibuprofen.

Can I use Children's Ibuprofen if my child has a history of stomach problems?

Consult a doctor before use if your child has a history of stomach problems, high blood pressure, heart disease, or other serious health conditions.

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

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

What should I do in case of an overdose?

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

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

Ibuprofen is an oral suspension formulated as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. Each 5 mL of the suspension contains 100 mg of ibuprofen. The product is alcohol-free and dye-free, with a berry flavor to enhance palatability. It is indicated for use in pediatric patients aged 2 to 11 years and provides relief that lasts up to 8 hours. The total volume of the suspension is 4 fluid ounces (120 mL).

Uses and Indications

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

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

Dosage and Administration

The medication should be shaken well before use. It is imperative to utilize only the enclosed dosing cup for administration; other dosing devices are not recommended. Healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight or age, prioritizing weight when possible.

The following dosing guidelines apply:

  • For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose.

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

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

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

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

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

If necessary, doses may be repeated every 6 to 8 hours, but it is important not to exceed a total of 4 doses in a 24-hour period.

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/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 of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

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 extended periods.

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

In the event of an overdose, immediate medical attention is required. Healthcare professionals should advise caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

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 indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is advised. Caregivers should also be vigilant for the emergence of any new symptoms.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, particularly in those with specific pre-existing conditions or sensitivities.

Severe allergic reactions can occur, especially 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 carries a warning for potential severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroid drugs, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of treatment. Signs of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Additionally, ibuprofen is associated with an increased 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.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly. The use of ibuprofen should not exceed two days in such cases, nor should it be administered to children under three years of age without a doctor's direction.

It is advised to discontinue use and consult a healthcare professional if any of the following occur: the child does not achieve relief within the first 24 hours of treatment; fever or pain worsens or persists beyond three days; redness or swelling is observed in the painful area; or any new symptoms arise.

Additional precautions include avoiding the use of ibuprofen in children with a history of allergic reactions to the drug or other pain relievers/fever reducers, and it should not be used immediately before or after heart surgery. Prior to use, consultation with a healthcare provider is recommended if the child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, it is important to inform the healthcare provider if the child is taking diuretics or is under care for any serious condition.

Drug Interactions

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

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

Additionally, the risk of stomach bleeding is further elevated when ibuprofen is used in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should exercise caution and evaluate the necessity of multiple NSAID therapies in these cases.

For patients taking diuretics, it is advisable to consult a healthcare professional prior to initiating ibuprofen therapy, as potential interactions may warrant dosage adjustments or enhanced monitoring.

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 healthcare professional. For dosing, the following guidelines apply:

  • For patients under 24 lbs (under 2 years): Consult a doctor.

  • For patients weighing 24-35 lbs (2-3 years): Administer 5 mL.

  • For patients weighing 36-47 lbs (4-5 years): Administer 7.5 mL.

  • For patients weighing 48-59 lbs (6-8 years): Administer 10 mL.

  • For patients weighing 60-71 lbs (9-10 years): Administer 12.5 mL.

  • For patients weighing 72-95 lbs (11 years): Administer 15 mL.

Healthcare professionals should advise parents or guardians to consult a doctor before use if the child has a history of stomach problems, is dehydrated, or has other serious health conditions.

If a child exhibits signs of stomach bleeding, symptoms of heart problems or stroke, or does not achieve relief within the first 24 hours of treatment, parents or guardians should stop use and seek medical advice.

This medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Geriatric use information is not explicitly provided in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions specifically mentioned for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and pharmacodynamics in this population. Regular monitoring and assessment of therapeutic response and adverse effects are advisable to ensure safe and effective use in elderly individuals.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Dosage modifications may be necessary, and pregnant women are advised to consult their healthcare provider for guidance before using ibuprofen. It is essential for healthcare professionals to consider these factors when advising pregnant patients or women of childbearing potential regarding the use of ibuprofen.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation in the provided drug insert for ibuprofen. Therefore, lactating mothers may use ibuprofen as directed, with no known adverse effects on breastfed infants reported in the available data.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate their treatment regimen.

Healthcare providers should exercise caution and tailor the treatment plan based on the individual patient's liver function and overall clinical picture.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No 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 have included gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and angioedema. Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been documented.

Cardiovascular events, including heart attack and stroke, have also been reported in association with the use of NSAIDs, including ibuprofen. Furthermore, liver enzyme elevations have been observed in some patients during postmarketing surveillance. Serious skin reactions, such as exfoliative dermatitis and erythema multiforme, have been noted in the postmarketing setting.

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 or contact a Poison Control Center immediately at 1-800-222-1222.

It is essential 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 medication 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, patients should be advised to 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.

Healthcare providers should emphasize 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, a doctor should be consulted. Patients should also be advised to seek medical advice if there is any redness or swelling in the painful area or if new symptoms arise.

When using this product, patients should be informed that it is advisable to take it with food or milk if stomach upset occurs. Healthcare providers should encourage patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies.

Patients should be advised to seek medical guidance 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, patients should be instructed to consult 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.

Finally, healthcare providers should recommend that patients 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 carton that contains a bottle, which must remain sealed until use. It is essential to inspect the carton and bottle wrap prior to use; the product should not be utilized if the carton is opened or if the bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.

Storage conditions require the product to be maintained at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. 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 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.