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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 2023
Label revision date
March 20, 2025
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 2023
Label revision date
March 20, 2025
Manufacturer
Albertsons
Registration number
ANDA209207
NDC root
21130-656
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 that contains ibuprofen, a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed for children aged 2 to 11 years 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.

This medication comes in a pleasant berry flavor and is dye-free and alcohol-free, making it suitable for children. Each dose provides 100 mg of ibuprofen per 5 mL, and its effects can last for up to 8 hours, providing effective relief when your child needs it.

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 you use this medication, make sure to shake the bottle well. It's important to use only the enclosed dosing cup to measure your dose—other devices may not provide the correct amount. To find the right dose, refer to the dosing chart based on your child's weight. If you can't use weight, you can use their age instead.

For children weighing under 24 pounds (younger than 2 years), it's best to consult a doctor before giving any dose. For those 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 between 60 and 71 pounds (ages 9-10 years), it's 12.5 mL. Finally, if your child weighs 72 to 95 pounds (11 years old), 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 are also warnings regarding heart attack and stroke, as NSAIDs (excluding aspirin) can increase these risks, particularly when used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, stomach pain, or any signs of heart problems (like chest pain or trouble breathing), it’s important to seek medical advice immediately. Always 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 ibuprofen 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 or your child experience severe sore throat symptoms, high fever, or if symptoms persist for more than two days, consult a doctor.

In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222. You should also call your doctor if you notice any signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or trouble breathing), or if there is no relief within 24 hours of treatment. If fever or pain worsens or lasts more than three days, or if new symptoms appear, contact your doctor right away.

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 safety is 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 particular considerations or precautions you need to take when using this medication during lactation (the period of breastfeeding).

Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding, but based on the current information, ibuprofen does not pose specific risks for nursing mothers.

Pediatric Use

When giving this medication to children, it's important to follow the dosing guidelines carefully. You should never exceed the recommended dose. For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor before administering the medication. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the appropriate dose is 5 mL. As children grow, the dosage increases: 7.5 mL for ages 4 to 5 years (36-47 lbs), 10 mL for ages 6 to 8 years (48-59 lbs), 12.5 mL for ages 9 to 10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs).

Additionally, if your child has a sore throat, do not use this medication for more than 2 days, and avoid giving it to children under 3 years old unless a doctor has specifically advised you to do so. Always prioritize safety and consult with a healthcare professional if you have any questions or concerns.

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 adjustments to your dosage or additional monitoring based on your specific health needs. Always prioritize open communication with your doctor regarding your kidney health and any other medical conditions you may have.

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). This is crucial to ensure that the medication is safe and effective for you.

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

Drug Interactions

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

If your child is on a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider. Always discuss any medications or tests with your doctor to ensure safety and avoid serious side effects.

Storage and Handling

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

Additionally, make sure to look at the bottom panel of the carton for the lot number and expiration date, as this information is important for tracking and safety. Proper handling and storage will help you use the product safely and effectively.

Additional Information

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

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

FAQ

What is Children's Ibuprofen?

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

What conditions does Children's Ibuprofen relieve?

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 suitable for children aged 2 to 11 years.

How should I dose Children's Ibuprofen?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight. If possible, use weight to determine the dose; otherwise, use age.

What should I do if my child has a severe sore throat?

Consult a doctor if your child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

What are the signs of a severe allergic reaction to ibuprofen?

Signs may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Seek medical help immediately if these occur.

What precautions should I take regarding stomach bleeding?

Be cautious if your child has a history of stomach ulcers or is taking blood thinners, as ibuprofen may increase the risk of severe stomach bleeding.

Can I use Children's Ibuprofen if my child has had an allergic reaction to pain relievers?

No, do not use Children's Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

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

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 features a berry flavor. It is free from dyes and alcohol, ensuring a suitable option for pediatric use. The effects of the medication can last up to 8 hours.

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

Healthcare professionals should instruct patients to shake the medication well before use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

To determine the appropriate dose, practitioners should refer to the dosing chart, prioritizing weight for dosing whenever possible. If weight is not available, age may be used as a secondary measure. The following dosing recommendations apply:

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

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

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

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

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

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

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

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

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

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

NSAIDs, with the exception of aspirin, are known to elevate the 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.

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

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

Healthcare providers should instruct caregivers to discontinue ibuprofen and contact a physician if the child exhibits any of the following signs of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, medical advice should be sought if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

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, or if any new symptoms arise, it is crucial to seek medical evaluation.

Side Effects

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.

As an NSAID, ibuprofen carries a risk of severe stomach bleeding, which 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, ibuprofen, or naproxen). The risk of stomach bleeding is also increased if the medication is taken in higher doses or for longer durations than recommended.

Additionally, the use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used beyond the directed dosage or duration.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting, and should seek medical attention promptly. It is advised not to use ibuprofen for more than two days or in children under three years of age without a doctor's guidance.

Parents should discontinue use and consult a physician if their child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, 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, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation.

It is contraindicated to use ibuprofen in children with a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, and it should not be administered immediately before or after heart surgery. Prior to use, consultation with a healthcare provider is recommended if the child has a history of stomach issues, has experienced serious side effects from pain relievers, is dehydrated, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Special caution is advised for children with asthma or those taking diuretics. Additionally, it is prudent to consult a doctor or pharmacist if the child 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. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

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

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

For children who are prescribed diuretics, it is advisable to consult a healthcare professional prior to initiating ibuprofen therapy to ensure safe and effective use.

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 should not exceed the recommended dosage. For children under 24 lbs or under 2 years of age, consultation with a healthcare professional is advised before administration. The following dosing chart provides guidance for children aged 2 years and older:

  • 24-35 lbs (2-3 years): 5 mL

  • 36-47 lbs (4-5 years): 7.5 mL

  • 48-59 lbs (6-8 years): 10 mL

  • 60-71 lbs (9-10 years): 12.5 mL

  • 72-95 lbs (11 years): 15 mL

Caution is advised regarding the use of this medication for sore throat. It should not be used for more than 2 days or administered to children under 3 years of age unless directed by a healthcare professional.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The text does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific 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 are no specific considerations or precautions related to lactation mentioned in the provided text.

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, or liver cirrhosis, as these may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

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

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant 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 treatment plan and monitoring requirements.

Overdosage

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

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

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and continuous monitoring of vital signs.

It is essential to document the incident thoroughly, including the substance involved, the amount taken, and the time of ingestion, to facilitate appropriate treatment and follow-up care.

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 limits the assessment of potential risks associated with the compound in these areas.

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, as well as in those taking anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been noted as serious conditions that require prompt medical consultation.

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 informed that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important to avoid use right before or after heart surgery.

Healthcare providers should instruct 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. Furthermore, patients should be advised to seek medical attention if the child shows symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Patients should also be informed 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 for more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, it is recommended that it be taken with food or milk to minimize the risk of stomach upset. 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 problems such as heartburn.

Patients should be advised to seek medical advice before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea. Additionally, it is important to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic.

Finally, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a carton that contains a bottle, with specific handling instructions to ensure safety and efficacy. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

Healthcare professionals should not use the product if the carton has been opened or if the bottle wrap, which is imprinted with "SEALED FOR SAFETY," is broken or missing. 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 experience.

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.