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Childrens Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
December 19, 2024
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 2017
Label revision date
December 19, 2024
Manufacturer
FAMILY WELLNESS
Registration number
ANDA209207
NDC root
55319-150
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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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 relief that can last up to 8 hours. This formulation is dye-free and alcohol-free, making it a gentle option for young ones, and it comes in a pleasant dye-free berry flavor.

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 if taken during pregnancy.

Dosage and Administration

Before you use the medication, make sure to shake the bottle well. It's important to use only the dosing cup that comes with the medication; avoid using any other measuring devices to ensure you get the correct amount. To find the right dose, refer to the dosing chart based on your child's weight. If you can, use their weight for a more accurate dose; if not, you can use their age instead.

For children weighing under 24 pounds or younger than 2 years, it's best to consult a doctor for the appropriate dose. For those weighing between 24 and 35 pounds (ages 2-3 years), the dose is 5 mL. If your child weighs between 36 and 47 pounds (ages 4-5 years), the dose increases to 7.5 mL. For children weighing 48 to 59 pounds (ages 6-8 years), the dose is 10 mL, and for those weighing 60 to 71 pounds (ages 9-10 years), the dose is 12.5 mL. Finally, if your child weighs between 72 and 95 pounds (age 11 years), the dose is 15 mL.

If needed, you can repeat the dose every 6 to 8 hours, but remember not to exceed 4 doses in a single day.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal, particularly if used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, stomach bleeding signs (like faintness, vomiting blood, or black stools), or symptoms of heart problems (such as chest pain or trouble breathing), seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

Warnings and Precautions

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

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

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and consult a doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness), or if their condition does not improve within 24 hours. Additionally, seek medical advice if fever or pain worsens or lasts more than three days, or if any new symptoms arise.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen during pregnancy has not been established. In fact, ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen could potentially lead to cardiovascular issues for the fetus.

Before taking any medication, including ibuprofen, you should consult your healthcare provider to discuss your options and ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could pose risks to your infant. Therefore, exercising caution is essential when considering this medication while nursing. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

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

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or has experienced significant fluid loss from vomiting or diarrhea. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, stop using the medication and seek medical advice. Remember to keep the medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your treatment plan. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

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

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these factors can also influence your care plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, taking ibuprofen can lead to severe stomach bleeding, especially if you are also using blood thinners (medications that prevent blood clots) or steroids, or if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen. Additionally, using NSAIDs, except for aspirin, may increase your risk of heart attack and stroke, particularly if you take them more than recommended or for an extended period.

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

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This range is considered a controlled room temperature, which helps maintain the product's quality. Always check the carton before use; do not use the product if the carton is opened or if the bottle wrap marked "SEALED FOR SAFETY" is broken or missing.

Additionally, make sure to look at the bottom panel of the carton for the lot number and expiration date, as this information is important for tracking the product's safety and effectiveness. Proper handling and storage are key to ensuring you get the best results from your product.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a day. If you experience stomach upset, it's advisable to take the medication with food or milk.

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen?

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

What age group is Children's Ibuprofen suitable for?

It is suitable for children aged 2 to 11 years.

How does Children's Ibuprofen work?

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

What should I do before using Children's Ibuprofen?

Shake well before using and use only the enclosed dosing cup to measure the dose.

How often can I give Children's Ibuprofen?

You can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day.

What are the dosing recommendations for Children's Ibuprofen?

Dosing varies by weight: for example, children weighing 24-35 lbs (2-3 years) should receive 5 mL, while those weighing 72-95 lbs (11 years) should receive 15 mL.

Are there any contraindications for using Children's Ibuprofen?

Do not use if your child has had an allergic reaction to ibuprofen or any other pain reliever, or if they are about to undergo heart surgery.

What are the potential side effects of Children's Ibuprofen?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke, especially if used improperly.

What should I do if my child experiences severe side effects?

Stop use and seek medical help immediately if your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours.

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

Safety during pregnancy has not been established, and it is contraindicated, especially in the third trimester.

Can nursing mothers use Children's Ibuprofen?

Nursing mothers should consult a doctor before using this product due to potential risks to the infant.

How should Children's Ibuprofen be stored?

Store at 20° to 25°C (68° to 77°F) and do not use if the carton is opened or if the safety seal is broken.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Childrens 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, USP is formulated as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. Each 5 mL dose contains 100 mg of ibuprofen. The suspension is presented in a 4 fl oz (120 mL) bottle and is characterized by its dye-free and alcohol-free formulation. It is flavored with berry to enhance palatability for pediatric patients.

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

Shake the product well before use. Administration should be performed using only the enclosed dosing cup; other dosing devices are not recommended. Healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight. If weight is not available, age may be used as a secondary reference.

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

If necessary, doses may be repeated every 6 to 8 hours, but should not exceed 4 doses in a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer should not use this product due to the risk of severe allergic reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

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

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

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

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

In the event of an overdose, immediate medical attention is required. Contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Healthcare providers should advise patients to discontinue use and consult a physician 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 indicative 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; or the emergence of any new symptoms.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

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

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

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

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

Patients should not use ibuprofen if they have a history of allergic reactions to the drug or any other pain reliever/fever reducer, and it should not be administered immediately before or after heart surgery. Prior to use, it is essential to consult a healthcare provider if the child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, patients under a doctor's care for serious conditions or those taking other medications should seek advice from a healthcare professional or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen has several notable drug interactions that may impact patient safety and treatment efficacy.

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing ibuprofen to patients who are on these medications. Monitoring for signs of gastrointestinal distress is advised.

Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The use of ibuprofen in conjunction with other NSAIDs, such as aspirin, naproxen, or additional ibuprofen, can elevate the risk of adverse gastrointestinal effects, including severe bleeding. It is recommended that healthcare providers avoid prescribing multiple NSAIDs concurrently and monitor patients closely for any signs of bleeding.

Cardiovascular Risks The use of NSAIDs, excluding aspirin, is associated with an increased risk of cardiovascular events, including heart attack and stroke, particularly when used in higher doses or for extended periods. Clinicians should assess the necessity of NSAID therapy and consider alternative pain management strategies, especially in patients with pre-existing cardiovascular conditions.

Diuretics In pediatric patients, it is essential to consult a healthcare provider if the child is currently taking a diuretic before initiating ibuprofen therapy. This is to ensure appropriate monitoring and to mitigate any potential risks associated with the combined use of these medications.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For dosing, the following guidelines apply:

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

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

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

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

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

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

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, is taking other medications, or has experienced significant fluid loss due to vomiting or diarrhea. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, parents or guardians should stop use and seek medical advice.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with risks such as potential cardiovascular effects on the developing fetus.

Women who are pregnant or planning to become pregnant should consult a healthcare provider before using ibuprofen to discuss the potential risks and benefits. It is essential to consider alternative pain management options that may be safer during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering to nursing mothers due to the potential risk to the infant.

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 cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach for those with hepatic impairment.

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. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and specific interventions based on the substance involved. It is vital for healthcare providers to remain vigilant and prepared to implement necessary measures to ensure patient safety and recovery.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning 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, severe stomach bleeding has been reported, particularly in children with a history of stomach ulcers or bleeding problems, or those concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Reports of serious side effects have included symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling. Other adverse reactions noted in the postmarketing experience encompass gastrointestinal issues, renal impairment, and liver dysfunction.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to take the medication with food or milk if they experience stomach upset. It is important to inform patients to stop use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Additionally, patients should be made aware to discontinue 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 advised to stop use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Healthcare providers should encourage patients to consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues, such as heartburn. It is also essential to advise patients to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea.

Furthermore, patients should be instructed to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with children who have asthma or are taking diuretics should also seek medical advice prior to use. Lastly, it is recommended that patients consult a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a carton that contains a bottle, which must remain sealed until use. It is essential to inspect the carton and bottle wrap prior to use; the product should not be utilized if the carton is opened or if the bottle wrap marked "SEALED FOR SAFETY" is broken or missing.

Storage conditions require the product to be maintained at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. For traceability, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6 to 8 hours as needed, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset.

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

Drug Information (PDF)

This file contains official product information for Childrens 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 Childrens 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.

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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.