Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Ibuprofen

Last content change checked dailysee data sync status

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 2002
Label revision date
October 26, 2022
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 2002
Label revision date
October 26, 2022
Manufacturer
Kroger Company
Registration number
ANDA074937
NDC root
30142-166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Children's Ibuprofen is an oral suspension medication designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen 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, providing comfort when your child is feeling unwell.

This medication is alcohol-free and comes in a pleasant bubble gum flavor, making it easier for children to take. Its effects can last up to 8 hours, offering extended relief for your child's discomfort.

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 harm to a developing fetus.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to shake the bottle well before each use. To find the right dose for you or your child, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age instead. Remember to use only the enclosed dosing cup for measuring, as other devices may not provide accurate amounts.

You can repeat the dose every 6 to 8 hours if needed, but do not exceed four doses in a single day. After each use, wash the dosing cup to keep it clean. Finally, make sure to replace the original bottle cap after use to maintain its child-resistant feature. If your child weighs under 24 pounds or is under 2 years old, it's best to consult a doctor for the appropriate dose.

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 any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after your child has undergone heart surgery, as it may 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 the 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, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or black stools, or shows signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that ibuprofen is not recommended, especially during the third trimester. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy can pose risks to your baby, including potential heart and kidney issues.

To ensure the safety of both you and your developing fetus, you should avoid taking ibuprofen unless your healthcare provider specifically advises you to do so. If you do need pain relief or anti-inflammatory treatment, consult your healthcare provider for guidance on safe alternatives and any necessary dosage adjustments.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. While ibuprofen can be helpful for pain relief, there is a possibility that it can pass into your breast milk. The effects of ibuprofen on nursing infants haven't been thoroughly studied, so it's wise to be cautious.

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

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it in children under 3 years of age 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, if your child weighs between 24-35 pounds and is 2-3 years old, the recommended dose is 5 mL. Always consult your doctor if your child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, or has conditions like high blood pressure, heart disease, or asthma.

Make sure to follow the dosing guidelines carefully and use the enclosed dosing cup for accuracy. You should not give this medication for more than 2 days without consulting a doctor, and if your child has been vomiting or has diarrhea, it's best to seek medical advice. If you need to repeat the dose, do so every 6-8 hours, but do not exceed 4 doses in a day.

Geriatric Use

When considering the use of this product for older adults, it's important to note that its safety and effectiveness have not been fully established for this age group. If you or a loved one is elderly, be aware that kidney function may be reduced, which could require adjustments to the dosage. Additionally, older adults may be more sensitive to side effects, so monitoring for any unusual reactions is crucial.

If you have high blood pressure, heart disease, liver cirrhosis (a liver condition), kidney disease, or a history of stroke, it's especially important to use caution. Always consult with a healthcare provider before starting any new medication to ensure it’s safe and appropriate for your specific 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 doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any medications you are considering.

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 (blood 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 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, combining ibuprofen with blood thinners (medications that prevent blood clots) or steroids can significantly increase the risk of serious stomach bleeding. The risk is also heightened if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are being used.

Using ibuprofen for extended periods or in higher doses than recommended can raise the chances of heart-related issues, such as heart attack or stroke. If your child is on a diuretic (a medication that helps remove excess fluid), it's crucial to consult with a healthcare provider before using ibuprofen. Always discuss any medications or tests with your healthcare provider 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 disposal instructions provided to ensure safety and compliance.

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

Before using the medication, ensure that the printed neckband is intact. Shake the bottle well before use and always use the enclosed dosing cup to measure your dose—do not use any other device. Refer to the dosing chart to find the correct dose based on weight or age, and remember to wash the dosing cup after each use.

FAQ

What is children's Ibuprofen?

Children's Ibuprofen is an oral suspension that acts as a pain reliever and fever reducer, containing 100 mg of ibuprofen per 5 mL.

What conditions does children's Ibuprofen treat?

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

What is the recommended age for using children's Ibuprofen?

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

How should I dose children's Ibuprofen?

You should find the right dose on the dosing chart based on your child's weight or age, and use only the enclosed dosing cup.

What are the dosing guidelines for children's Ibuprofen?

Doses vary by weight: for example, 5 mL for children weighing 24-35 lbs (2-3 years) and 15 mL for those weighing 72-95 lbs (11 years).

What should I do if my child experiences stomach bleeding?

If your child shows signs of stomach bleeding, such as fainting or vomiting blood, stop use and seek medical help immediately.

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

Do not use children's Ibuprofen if your child has ever had an allergic reaction to any other pain reliever or fever reducer.

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

Ibuprofen is contraindicated during pregnancy, especially in the third trimester, due to potential risks to the fetus.

What should I do if my child does not get relief from pain or fever?

If your child does not experience relief within the first 24 hours, or if symptoms worsen, consult a doctor.

How should I store children's Ibuprofen?

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

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 formulated to provide pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is alcohol-free and is designed to last up to 8 hours. It is presented in a bubble gum flavor for palatability and is packaged in a 4 FL OZ (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 dose 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 used for accurate measurement; no other dosing devices should be employed.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL. For patients weighing 36-47 lbs (4-5 years), the dose is 7.5 mL. For those weighing 48-59 lbs (6-8 years), the dose is 10 mL. For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the dose is 15 mL.

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

Contraindications

Use is contraindicated in children with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe allergic responses. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to the patient's recovery and overall cardiovascular stability.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, or naproxen). It is crucial to adhere strictly to the recommended dosage and duration of use to mitigate this risk.

NSAIDs, excluding aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is exacerbated by exceeding the recommended dosage or duration of treatment.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Patients should be advised not to use ibuprofen for more than two days or to administer it to children under three years of age without prior consultation with a physician.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur:

  • Signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain.

  • Symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

  • Lack of relief within the first 24 hours of treatment.

  • Worsening fever or pain lasting more than three days.

  • Presence of redness or swelling in the affected area.

  • Emergence of any new symptoms.

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

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 potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk is particularly significant when the medication is used in higher doses or for extended periods.

In pediatric patients, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days in children under three years of age unless directed by a physician.

Patients are advised to discontinue use and seek medical attention 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 evaluation. 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 advice should be sought.

Before using ibuprofen, it is important for patients to consult a healthcare provider if any of the following conditions apply: a history of stomach problems, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a previous stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use.

Lastly, patients under a physician's care for any serious condition or those taking other medications should also consult a healthcare professional before using ibuprofen.

Drug Interactions

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

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is essential 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 severe gastrointestinal bleeding. This risk is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies in at-risk populations.

Cardiovascular Risks The use of ibuprofen may elevate the risk of serious cardiovascular events, such as heart attack, heart failure, and stroke, particularly when used in higher doses or for extended periods. It is advisable to limit the duration and dosage of ibuprofen to the minimum effective amount and to evaluate the patient's cardiovascular risk factors prior to initiation.

Diuretics Patients taking diuretics should consult a healthcare provider before using ibuprofen, as the combination may necessitate dosage adjustments or increased monitoring for 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 years and older, dosing is based on weight and age as follows:

  • For children under 24 lbs (under 2 years), consult a doctor.

  • For those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

  • For children weighing 36-47 lbs (4-5 years), the dose is 7.5 mL.

  • For those weighing 48-59 lbs (6-8 years), the dose is 10 mL.

  • For children weighing 60-71 lbs (9-10 years), the dose is 12.5 mL.

  • For those weighing 72-95 lbs (11 years), the dose is 15 mL.

The medication should not be used for more than 2 days, and if symptoms persist, a doctor should be consulted.

Healthcare professionals should advise caution and recommend consulting a doctor if the pediatric patient has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is necessary if the child has not been adequately hydrated due to vomiting or diarrhea, or if there are pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Children taking diuretics or under a doctor's care for any serious condition should also be evaluated by a healthcare professional before using this medication. If a dose is needed, it may be repeated every 6-8 hours, but should not exceed 4 doses in a 24-hour period. Only the enclosed dosing cup should be used for administration; other dosing devices are not recommended.

Geriatric Use

Elderly patients may exhibit reduced kidney function, which could necessitate dosage adjustments when using this product. The safety and efficacy of ibuprofen in geriatric patients have not been established, highlighting the need for caution in this population.

In addition, increased sensitivity to side effects may be observed in elderly patients. Therefore, it is advisable to closely monitor these patients, particularly those with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Careful consideration of these factors is essential to ensure safe and effective use of this product in geriatric patients.

Pregnancy

Ibuprofen is contraindicated in pregnancy, particularly during the third trimester. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with risks to the fetus, such as potential cardiovascular effects and renal impairment. There is a recognized risk of adverse effects on fetal development when NSAIDs are used during pregnancy.

Due to these safety concerns, dosage adjustments may be necessary, and it is advised that pregnant patients consult a healthcare provider before using ibuprofen. Special precautions should be taken, and pregnant women should avoid using ibuprofen unless specifically directed by a healthcare professional.

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 liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications or the need for alternative therapeutic options. Regular follow-up assessments are advised to monitor any changes in liver function that may impact treatment decisions.

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 help 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 and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include hives, facial swelling, asthma characterized by wheezing, shock, skin reddening, rash, and blisters.

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 crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

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 not to use the medication if the printed neckband is broken or missing, and to shake the bottle well before use. It is essential to utilize only the enclosed dosing cup for administration, following the dosing chart to determine the appropriate dose based on weight or age. Additionally, patients should wash the dosing cup after each use to ensure proper hygiene.

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.