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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 2021
Label revision date
November 8, 2024
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 2021
Label revision date
November 8, 2024
Manufacturer
Rite Aid Corporation
Registration number
ANDA074916
NDC root
11822-3310
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

Children's Ibuprofen is a fever reducer and pain reliever specifically designed for children aged 2 to 11 years. It comes in an oral suspension form with a berry flavor and contains ibuprofen (a nonsteroidal anti-inflammatory drug, or NSAID) as its active ingredient. This medication helps relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also effectively reducing fever.

The ibuprofen in Children's Ibuprofen works by decreasing inflammation and pain, providing relief that can last up to 8 hours. It is alcohol-free and includes a dosage cup for easy measurement. Always ensure to read the product information before use to understand its proper application for your child.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To find the right dose for you or your child, refer to the dosing chart provided. If possible, use weight to determine the dose; if not, you can use age. It's important to use only the enclosed dosing cup to measure the medication—other devices may not provide the correct amount.

You should take the dose every 6 to 8 hours if needed, but do not exceed four doses in a single day. Remember, if your child weighs less than 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL; for those weighing 36 to 47 pounds (ages 4-5), it's 7.5 mL; and so on, up to 15 mL for children weighing 72 to 95 pounds (age 11). After using the medication, always replace the original bottle cap to keep it safe from children.

What to Avoid

It's important to be cautious when using this medication for your child. You should stop use and consult a doctor if your child shows any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, seek medical advice if your child exhibits symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

If your child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than three days, discontinue use and contact a healthcare professional. Also, stop use if you notice any redness or swelling in the painful area, or if any new symptoms arise. Your child's safety and well-being are the top priority, so don't hesitate to reach out to a doctor with any concerns.

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 life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, or slurred speech. Always consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or persist beyond a few days.

Warnings and Precautions

You should be aware that ibuprofen can cause severe allergic reactions, particularly if you are allergic to aspirin. Symptoms of an allergic reaction 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.

Ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that can lead to serious stomach bleeding, especially if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for longer than recommended. If you or your child experience symptoms like faintness, vomiting blood, or black stools, or if there are signs of heart problems such as chest pain or difficulty breathing, stop using ibuprofen and contact a doctor right away.

It's important to consult a doctor if a sore throat persists for more than two days, especially if accompanied by high fever, headache, nausea, or vomiting. Additionally, if symptoms do not improve within 24 hours, or if fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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 reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

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

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

Lactation Use

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

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

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. For example, if your child weighs under 24 pounds, consult a doctor first. If they weigh between 24-35 pounds, the recommended dose is 5 mL, and it increases with weight up to 15 mL for those weighing 72-95 pounds.

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or isn't drinking enough fluids. It's also crucial to limit use to no more than 2 days for sore throat symptoms, and seek medical advice if your child doesn't feel better within 24 hours or if fever or pain lasts more than 3 days. Keep this medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Geriatric Use

While the information provided does not include specific guidelines for older adults, it's important to approach any medication with caution, especially if you or a loved one is elderly. Since there are no recommended age considerations or dosage adjustments mentioned, it’s advisable to consult with a healthcare professional before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health needs. Always prioritize open communication with your doctor about any concerns or existing health conditions.

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 (a 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 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 your child is taking medications. For instance, if your child is allergic to aspirin, using ibuprofen could lead to severe allergic reactions. Additionally, if your child is on blood thinners or steroid medications, the risk of stomach bleeding increases significantly. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

Before giving any medication, including ibuprofen, it's crucial to consult with a healthcare provider, especially if your child is taking diuretics or any other drugs. Always check with a doctor or pharmacist to ensure that the medications are safe to use together. Your child's safety is the top priority, so open communication with healthcare professionals is key.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20º to 25ºC (68º to 77ºF). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a sterile environment to prevent contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with local regulations.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen used for?

Children's Ibuprofen is used as a fever reducer and pain reliever for minor aches and pains due to the common cold, flu, sore throat, headache, and toothache.

What is the active ingredient in Children's Ibuprofen?

The active ingredient in Children's Ibuprofen is Ibuprofen, which is a nonsteroidal anti-inflammatory drug (NSAID).

What is the recommended dosage for a child weighing 36-47 lbs?

For a child weighing 36-47 lbs (ages 4-5 years), the recommended dose is 7.5 mL.

How often can I give Children's Ibuprofen?

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

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

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

Is there a risk of allergic reactions with Children's Ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, especially in individuals allergic to aspirin. Symptoms can include hives, facial swelling, and difficulty breathing.

Can I use Children's Ibuprofen for a sore throat?

You can use it for a sore throat, but do not use it for more than 2 days or for children under 3 years of age unless directed by a doctor.

What should I do if my child does not get relief within 24 hours?

If your child does not get any relief within the first day (24 hours) of treatment, stop use and ask a doctor.

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

The provided information does not mention any specific risks or recommendations regarding the use of ibuprofen during pregnancy.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen between 20º to 25º C (68º to 77º F).

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 classified as a nonsteroidal anti-inflammatory drug (NSAID). The active ingredient is ibuprofen, with a strength of 100 mg per 5 mL. This formulation features a berry flavor and is alcohol-free. A dosage cup is included for accurate measurement. It is indicated for use in children aged 2 to 11 years and provides relief that lasts up to 8 hours. The product is tamper-evident; do not use if the printed neckband is broken or missing. Additionally, it is free of parabens and is comparable to the active ingredient in Children's Motrin®†. It is essential to read all product information prior to use and retain the packaging for important details. This product is specifically intended for pediatric use.

Uses and Indications

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

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

Dosage and Administration

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

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

If necessary, doses may be repeated every 6 to 8 hours, but it is crucial not to exceed four doses in a 24-hour period. After use, the original bottle cap should be replaced to ensure child resistance. Healthcare professionals should emphasize that no more than the directed amount should be administered.

Contraindications

Use is contraindicated in the following situations:

  • If the child experiences signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain.

  • If the child exhibits symptoms of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

  • If there is no relief within the first 24 hours of treatment.

  • If fever or pain worsens or persists beyond 3 days.

  • If redness or swelling occurs in the painful area.

  • If any new symptoms develop.

In these cases, it is essential to discontinue use and consult a healthcare professional.

Warnings and Precautions

Ibuprofen may elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, and individuals taking other NSAIDs, whether prescription or over-the-counter, such as aspirin or naproxen. Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

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

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Any new or unusual symptoms should also prompt a discussion with a healthcare professional.

In the event of an overdose, it is critical to seek medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage may increase this risk.

Patients should also be aware of 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 with higher doses or extended duration of use.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation.

Patients should 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 necessitate immediate medical attention.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare professional. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a medical evaluation.

Before using this product, it is advisable for patients to consult a healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have 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, it is important to inform a healthcare provider if the patient is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, it is important to note that the risk of gastrointestinal bleeding is significantly elevated. This risk is further compounded if the child is also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen.

In cases where a child is prescribed a diuretic, it is advisable to consult a healthcare professional prior to administering ibuprofen to ensure safety and appropriate management.

Furthermore, it is recommended that caregivers seek guidance from a doctor or pharmacist before using ibuprofen in conjunction with any other medications the child may be taking, to mitigate potential interactions and 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 healthcare professional. For dosing, the following guidelines apply based on weight:

  • For patients weighing under 24 lbs (under 2 years), consultation with a doctor is required.

  • 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.

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

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, is taking any medications, or has not been adequately hydrated. The medication should not be used for more than 2 days for sore throat or if symptoms worsen. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain persists for more than 3 days, parents should stop use and seek medical advice. It is essential to keep this medication out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Geriatric patients may not have specific use information provided in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for elderly patients. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in this population.

Pregnancy

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

Lactation

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

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 therapy in individuals with reduced kidney function. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

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 at 1-800-222-1222. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose will depend on the substance involved and the severity of the symptoms presented.

It is essential for healthcare providers to follow established protocols for overdose management, which may include supportive care and symptomatic treatment as necessary. Continuous assessment and appropriate interventions are vital to ensure patient safety and recovery.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients with a history of stomach ulcers or bleeding problems, or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, especially associated with prolonged use or doses exceeding the recommended guidelines. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been documented as serious conditions that necessitate prompt medical consultation.

Patient Counseling

Healthcare providers should advise patients 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 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 also be counseled to discontinue use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise.

When using this product, it is recommended that it be taken with food or milk to mitigate potential stomach upset.

Healthcare providers should encourage patients to consult a doctor before use if any of the following conditions apply: the child has a history of stomach bleeding, has experienced stomach problems such as heartburn, has had adverse reactions to pain relievers or fever reducers, has not been 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 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any conditions that may compromise the integrity of the product.

Additional Clinical Information

No further data are available.

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.