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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 2002
Label revision date
June 13, 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 2002
Label revision date
June 13, 2025
Manufacturer
Rite Aid Corporation
Registration number
ANDA074937
NDC root
11822-0660
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Children's Ibuprofen Oral Suspension is a medication designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

This oral suspension comes in a pleasant grape flavor and is gluten-free and alcohol-free, making it a suitable option for many children. A dosage cup is included to help you measure the correct amount for your child.

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 harm to a developing fetus. This makes it a safer choice for those who are pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. To ensure safety, always follow the recommended dosage and never exceed the amount directed. Start by shaking the bottle well before each use. You’ll find a dosing chart included, which helps you determine the right dose based on your child's weight. If you can, use their weight for dosing; if not, you can use their age instead.

Make sure to use only the enclosed dosing cup to measure the medicine, as other devices may not provide accurate measurements. For children weighing under 24 pounds (under 2 years), it's best to consult a doctor before giving any dose. For those between 24 and 35 pounds (2-3 years), the dose is 5 mL; for 36 to 47 pounds (4-5 years), it's 7.5 mL; for 48 to 59 pounds (6-8 years), it's 10 mL; for 60 to 71 pounds (9-10 years), it's 12.5 mL; and for children weighing 72 to 95 pounds (11 years), the dose is 15 mL. If needed, you can repeat the dose every 6 to 8 hours, but do not give more than four doses in a single day. After each use, wash the dosing cup and remember to replace the original bottle cap to keep it child-resistant.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction 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 are also warnings regarding heart attack and stroke risks associated with NSAIDs, which can be life-threatening. Symptoms to watch for include severe sore throat with high fever, chest pain, trouble breathing, weakness on one side of the body, slurred speech, and swelling in the legs. If your child experiences any signs of stomach bleeding, persistent pain, or does not improve within 24 hours, consult a doctor immediately. Always check with a healthcare professional before use if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, 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, stop use and contact your doctor right away.

If you or your child has a severe sore throat with high fever, headache, nausea, or vomiting, consult a doctor promptly. Do not use ibuprofen for more than two days without medical advice, especially for children under three years old. If symptoms worsen or do not improve within 24 hours, or if new symptoms appear, stop using the medication and reach out to your healthcare provider. In case of overdose, seek 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

The safety of ibuprofen during pregnancy has not been established, and it is particularly contraindicated (not recommended) during the third trimester. Using ibuprofen while pregnant may pose risks to your fetus, including potential cardiovascular effects.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using ibuprofen or any medication. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this important 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. Monitoring your infant can help ensure their safety while you manage your own discomfort.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years old unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, a child weighing between 24-35 pounds (2-3 years old) can take 5 mL, while a child weighing 72-95 pounds (11 years old) can take 15 mL. Always consult a doctor for the correct dosage and never use the medication for more than 2 days without guidance.

Before giving this medication, check with your doctor if your child has any history of allergies to pain relievers, stomach issues, or other serious health conditions. If your child shows any signs of stomach bleeding, heart problems, or if their symptoms worsen or do not improve within 24 hours, stop using the medication and seek medical advice.

Geriatric Use

When considering this product for older adults, it's important to consult with a doctor first, especially if you or your loved one has any of the following health conditions: high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, or a history of stroke. These conditions can affect how the product works and may require special attention or adjustments in dosage.

Please note that the product does not provide specific directions or warnings for adult use, which means that careful consideration and professional guidance are essential to ensure safety and effectiveness. Always prioritize open communication with healthcare providers to address any concerns or questions.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your doctor can help determine if this medication is safe for you and whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health and communicate openly with your healthcare provider about your medical history.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of the treatment.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are 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. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Using ibuprofen for extended periods or in higher doses than recommended can raise the chances of serious heart issues, including heart attack and stroke. If your child is taking a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider before using ibuprofen. Always discuss any medications or tests with your doctor to ensure safety and effectiveness.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Before using the medication, make sure to shake the bottle well. To find the correct dose, refer to the dosing chart; using weight is preferred, but age can be used if weight is not available. Always use the enclosed dosing cup for accuracy, and avoid using any other measuring devices. After each use, wash the dosing cup and ensure the original bottle cap is replaced to maintain child resistance.

FAQ

What is Children's Ibuprofen Oral Suspension used for?

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

What is the recommended dosage for Children’s Ibuprofen?

The dosage varies by weight: for children weighing 24-35 lbs (2-3 years), it's 5 mL; for 36-47 lbs (4-5 years), it's 7.5 mL; and so on. Always refer to the dosing chart or consult a doctor.

Are there any warnings associated with Children's Ibuprofen?

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

Can I give Children's Ibuprofen to my child if they are under 2 years old?

You should ask a doctor before giving Children's Ibuprofen to children under 2 years old, especially if they weigh under 24 lbs.

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

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, particularly during the third trimester. Consult a healthcare provider before use.

What should I do if my child experiences side effects?

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

How should I store Children's Ibuprofen?

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

Can nursing mothers use Children's Ibuprofen?

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

Children’s Ibuprofen Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) formulated for pediatric use, specifically for children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, providing effective pain relief and fever reduction. The suspension is presented in a 4 FL OZ (120 mL) bottle and is flavored with grape. It is free from gluten and alcohol, ensuring suitability for children with specific dietary restrictions. The formulation is designed to provide relief that lasts up to 8 hours, and a dosage cup is included for accurate measurement.

Uses and Indications

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

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

Dosage and Administration

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

For children weighing under 24 lbs (under 2 years), consultation with a physician is required prior to administration. For children weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Children weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. Finally, for children weighing 72-95 lbs (11 years), the appropriate dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use. It is critical to adhere to the recommended dosages and not exceed the directed amounts.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may 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.

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.

NSAIDs, excluding aspirin, are also 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 an extended period.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if such symptoms occur. Additionally, ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Discontinuation of ibuprofen and consultation with a healthcare professional is warranted if the child exhibits any of the following signs of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, if the child shows symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, immediate medical evaluation is necessary.

Caregivers should also seek medical advice if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise. Regular monitoring and prompt action are essential to ensure the safe use of ibuprofen in pediatric patients.

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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended duration.

There is also a significant warning regarding the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess of the directed dosage or for longer than advised.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's direction.

Patients are instructed to discontinue use and seek medical advice if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

Before using ibuprofen, it is essential for patients to consult a doctor if any of the aforementioned stomach bleeding warnings apply, or if there is a history of stomach issues, serious side effects from pain relievers or fever reducers, dehydration, or pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use. Additionally, consultation with a doctor or pharmacist is advised for patients under medical care for serious conditions or those taking other medications.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Ibuprofen may induce severe allergic reactions in individuals with a known allergy to aspirin. It is crucial for healthcare providers to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is further elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is advised in patients receiving these combinations.

Cardiovascular Risks There is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, associated with ibuprofen, particularly when used in higher doses or for extended periods. Healthcare providers should evaluate the necessity of ibuprofen therapy and consider alternative treatments when appropriate.

Diuretics Patients taking diuretics should consult their healthcare provider prior to initiating ibuprofen therapy. The interaction may necessitate dosage adjustments or increased monitoring to mitigate potential adverse effects.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

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

  • Under 24 lbs / Under 2 years: Ask a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

Dosing may also be adjusted as directed by a doctor. It is important not to exceed 2 days of use in pediatric patients or to administer the medication to children under 3 years of age without medical guidance.

Healthcare professionals should advise parents to consult a doctor before use if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, stomach problems (e.g., heartburn), serious side effects from pain relievers, dehydration, or any of the following conditions: high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke, asthma, or if the child is taking a diuretic.

Parents should be instructed to stop use and seek medical advice if the child exhibits signs of stomach bleeding, symptoms of heart problems or stroke, does not experience relief within the first 24 hours, if fever or pain worsens or persists beyond 3 days, or if redness or swelling occurs in the painful area.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, particularly due to the absence of specific directions or complete warnings for adult use. It is advisable for geriatric patients to consult a healthcare provider prior to use, especially if they have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Given the potential for increased sensitivity to medications in this population, careful monitoring and consideration of individual health status are essential. Healthcare providers should evaluate the risks and benefits of treatment in elderly patients, ensuring that any necessary dose adjustments or additional precautions are taken to mitigate potential adverse effects.

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.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

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 mother is taking ibuprofen while breastfeeding.

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 is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects that may arise from the medication's use in this population.

Overdosage

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

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs.

Allergic reactions, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters, have been documented. Additionally, cases of stomach bleeding have been reported in patients taking ibuprofen, particularly among those with a history of stomach ulcers or bleeding disorders. Furthermore, instances of heart attack and stroke have been noted in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, especially in individuals taking higher doses or using the medication for extended periods beyond the recommended guidelines.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended to administer the medication with food or milk if the child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, healthcare providers should inform patients to stop use and seek 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 be made aware that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should consult a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a doctor.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following conditions apply: the child has a history of stomach bleeding, has experienced stomach problems like heartburn, has had adverse reactions to pain relievers or fever reducers, is not adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic.

Furthermore, 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 currently taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product's quality and effectiveness throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to 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.

Patients should be instructed to shake the medication well before use and to refer to the dosing chart to determine the appropriate dose, ideally based on weight; if weight is not available, age may be used. It is essential to use only the enclosed dosing cup for administration and to wash it after each use. Additionally, patients should ensure the original bottle cap is replaced to maintain child resistance.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.