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Childrens Ibuprofen Oral Suspension, Bubble Gum

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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 2025
Label revision date
January 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
January 20, 2025
Manufacturer
Best Choice
Registration number
ANDA210602
NDC root
63941-127
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

Best Choice Children's Ibuprofen Oral Suspension is a medication designed specifically for children aged 2 to 11 years. This oral suspension contains ibuprofen, a type of nonsteroidal anti-inflammatory drug (NSAID), which helps relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it effectively reduces fever and has a pleasant bubble gum flavor to make it more appealing for kids.

The effects of this medication can last up to 8 hours, providing your child with relief when they need it most. Always ensure to read the product information before use to understand how to administer it safely.

Uses

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

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who are pregnant, although you should always consult with your healthcare provider before taking any medication.

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to follow the dosing instructions carefully. You should find the right dose based on the dosing chart, which considers your child's weight and age. If possible, use your child's weight for the most accurate dosage; otherwise, you can use their age. Always use the enclosed dosing cup to measure the dose—other devices may not provide the correct amount.

For children under 2 years old who weigh less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 and 35 pounds, the dose is 5 mL. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, the dose increases to 7.5 mL. For children aged 6 to 8 years weighing 48 to 59 pounds, the dose is 10 mL, while those aged 9 to 10 years and weighing 60 to 71 pounds should take 12.5 mL. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 15 mL. You can repeat the dose every 6 to 8 hours if needed, but do not exceed four doses in a day. Always remember to replace the original bottle cap after use to keep it safe from children.

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 it 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 side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If you notice any of these symptoms, stop using the medication and seek medical help immediately.

Additionally, ibuprofen carries risks of stomach bleeding, heart attack, and stroke. The risk of stomach bleeding is higher if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs. Signs of stomach bleeding include feeling faint, vomiting blood, or having black stools. If your child experiences chest pain, trouble breathing, or weakness on one side of the body, seek medical attention right away. Always consult a doctor if your child has a history of stomach problems, is dehydrated, or has other serious health conditions before using ibuprofen.

Warnings and Precautions

You should be aware that ibuprofen can cause serious allergic reactions, especially 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 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 notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop using ibuprofen and contact your doctor right away.

It's important to consult your doctor if you or your child has a severe sore throat that lasts more than two days, especially if accompanied by high fever, headache, nausea, or vomiting. You should also seek medical advice if symptoms of heart problems or stroke occur, such as chest pain, trouble breathing, weakness on one side of the body, slurred speech, or leg swelling. If there is no relief within 24 hours, or if fever or pain worsens or lasts more than three days, contact your doctor.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, you might notice symptoms such as nausea, vomiting, stomach pain, drowsiness, and headache. In more severe cases, an overdose can cause kidney failure, liver damage, and gastrointestinal bleeding.

If you suspect an overdose, it’s crucial to seek immediate medical attention. Don’t wait for symptoms to worsen; getting help quickly can make a significant difference in treatment and recovery. Always keep medications out of reach and follow the recommended dosages to avoid these risks.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that there is no detailed information available about how it may affect you or your baby, including whether any dosage adjustments or special precautions are necessary.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before starting any new medication. They can provide personalized advice based on your health and circumstances.

Lactation Use

If you are breastfeeding and considering using this product, it's important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of ibuprofen on nursing infants have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

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

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children who are 2 years and older, the dosage depends on their weight. For example, if your child weighs under 24 lbs, consult a doctor first. If they weigh between 24-35 lbs, the recommended dose is 5 mL; for 36-47 lbs, it's 7.5 mL; for 48-59 lbs, it's 10 mL; for 60-71 lbs, it's 12.5 mL; and for those weighing 72-95 lbs, the dose is 15 mL.

It's important to consult a doctor if your child has any history of stomach issues, has not been drinking fluids, or has lost fluids due to vomiting or diarrhea. Additionally, if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic, you should seek medical advice before using this medication. Always follow the dosing instructions carefully, do not exceed 4 doses in a day, and if necessary, doses can be repeated every 6-8 hours.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Always ensure that your doctor is aware of all medications being taken, as older adults may be more sensitive to certain drugs. Regular check-ins with your healthcare team can help monitor for any side effects or changes in health.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. If your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can also heighten this risk.

Before giving ibuprofen to your child, make sure to consult with a healthcare provider, especially if they are on a diuretic (a medication that helps remove excess fluid from the body) or any other medications. Always check with a doctor or pharmacist to ensure that it’s safe to use ibuprofen alongside any other drugs your child may be taking. This helps protect their health and avoid potential complications.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness. Additionally, always check the printed neckband before use; do not use the product if the neckband is broken or missing, as this could indicate that the product is compromised.

When handling the product, be sure to do so with clean hands and in a safe environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Best Choice Children's Ibuprofen Oral Suspension used for?

It is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What is the recommended dosage for children?

Dosage varies by weight and age. For example, children weighing 24-35 lbs (ages 2-3 years) should take 5 mL, while those weighing 72-95 lbs (age 11 years) should take 15 mL.

How often can I give this medication to my child?

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

Are there any warnings associated with this medication?

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

Can I use this medication for children under 2 years old?

For children under 2 years old or weighing less than 24 lbs, you should ask a doctor before use.

Is it safe to use this medication during pregnancy?

There is no specific information regarding the use of this medication during pregnancy, so consult a doctor.

What should I do if my child experiences side effects?

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

How should I store this medication?

Store it between 20-25° C (68-77° F) and do not use if the printed neckband is broken or missing.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen Oral Suspension, Bubble Gum.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Best Choice® Children's Ibuprofen Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) formulated for pediatric use. Each 5 mL dose contains 100 mg of ibuprofen, providing effective pain relief and fever reduction. This oral suspension is specifically designed for children aged 2 to 11 years and is available in a bubble gum flavor to enhance palatability. The product is packaged in a 4 FL OZ (118 mL) bottle, with effects lasting 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

This product is intended for use in pediatric patients and does not contain specific directions or complete warnings for adult use. Healthcare professionals should advise caregivers to adhere strictly to the recommended dosing guidelines and not exceed the directed dosage.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosing chart, which is based on the child's weight. If weight is not available, age may be used as a secondary reference. It is imperative to utilize only the enclosed dosing cup for measurement; other dosing devices are not recommended.

The dosing intervals are as follows: if necessary, the dose may be repeated every 6 to 8 hours, but the total daily administration should not exceed four doses.

For specific dosing based on weight and age, refer to the following chart:

  • For children weighing under 24 lbs (under 2 years of age), consult a doctor for the appropriate dose.

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

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

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

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

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

After use, the original bottle cap should be replaced to ensure child resistance. If there are any uncertainties regarding dosing, healthcare professionals should be consulted for further guidance.

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 indicative of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or others). Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

NSAIDs, with the exception of aspirin, are known to elevate the risk of serious cardiovascular events, including 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 prolonged 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. Furthermore, 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.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice 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. Additionally, symptoms suggestive of heart problems or stroke, such as 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 recommended. Caregivers should also be advised to report any new symptoms that arise during treatment.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Severe allergic reactions may occur, 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 and seek immediate medical assistance.

The use of ibuprofen carries a risk of severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, ibuprofen 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 in excess of the recommended dosage or for longer than directed.

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

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or 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 attention. If relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. Redness or swelling in the painful area or the emergence of new symptoms should also prompt consultation with a healthcare professional.

Before using ibuprofen, it is advisable to consult a doctor if the patient has a history of stomach problems, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has 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. Furthermore, individuals under a doctor's care for any serious condition or those taking other medications should consult a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

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

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

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies if necessary.

Diuretics Patients taking diuretics should consult a healthcare provider prior to using ibuprofen. The interaction may necessitate dosage adjustments or increased monitoring of renal function and electrolyte levels.

General Recommendations It is advisable for patients to seek guidance from a healthcare professional or pharmacist before initiating ibuprofen therapy, especially if they are currently taking other medications. This precaution helps to mitigate potential interactions and ensure safe use.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen Oral Suspension, Bubble Gum.
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 and age:

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

  • 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.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea. Additionally, consultation is recommended for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. If the child is taking a diuretic, a doctor should also be consulted.

The medication should not be used more than directed and should not exceed four doses in a 24-hour period. If necessary, doses may be repeated every 6-8 hours.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific mention of pregnancy use, safety concerns, dosage modifications, or special precautions regarding use during pregnancy in the provided text. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of ibuprofen can lead to serious adverse effects that require prompt medical intervention. Healthcare professionals should be aware of the potential symptoms and management strategies associated with ibuprofen overdosage.

Symptoms of Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, and headache. These symptoms can vary in severity depending on the amount ingested and the individual patient's response.

In more severe cases, an overdose can result in critical complications such as kidney failure, liver damage, and gastrointestinal bleeding. These conditions necessitate immediate medical evaluation and intervention.

Recommended Actions If an overdose is suspected, it is imperative to seek immediate medical attention. Healthcare providers should conduct a thorough assessment of the patient's condition and consider appropriate diagnostic tests to evaluate organ function and identify any potential complications. Management may include supportive care, monitoring of vital signs, and specific treatments aimed at mitigating the effects of the overdose.

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, as well as those taking blood thinners 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

Advise patients to keep this medication out of reach of children to prevent accidental ingestion. Instruct them that in the event of an overdose, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Inform patients 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 advise against its use right before or after heart surgery.

Patients should be instructed 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. They should also seek medical advice 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 swelling in the legs.

Patients should 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, patients should be advised to take it with food or milk if stomach upset occurs. It is also essential to recommend that they consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies.

Patients should be encouraged 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, they should consult a doctor if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke, as well as if the child has asthma or is taking a diuretic.

Finally, patients should be advised to consult a doctor or pharmacist before use if the child is under a doctor's care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25° C (68-77° F) to maintain its integrity and efficacy.

Care should be taken to ensure that the printed neckband remains intact; the product should not be used if the neckband is broken or missing, as this may indicate potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product's quality and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Oral Suspension, Bubble Gum, 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 Oral Suspension, Bubble Gum, 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.