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Childrens Ibuprofen Blue Raspberry, Childrens Ibuprofen Bubblegum, Childrens ...

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
October 13, 2021
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/ Drops
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
October 13, 2021
Manufacturer
Guardian Drug Company
Registration number
ANDA210149
NDC roots
53041-572, 53041-632, 53041-638, 53041-639
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (8 NDCs)
Packaging & NDC Codes (8)

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

GUARDIAN is a children's ibuprofen oral suspension, which is a type of nonsteroidal anti-inflammatory drug (NSAID). It is designed to relieve minor aches and pains caused by common conditions such as the cold, flu, sore throat, headache, and toothache. Additionally, GUARDIAN helps reduce fever in children aged 2 to 11 years.

This medication comes in a bubble gum flavor and is alcohol-free, making it more appealing for kids. Each dose contains 100 mg of ibuprofen per 5 mL, and its effects can last for up to 8 hours.

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.

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; avoid using any other measuring devices to ensure accuracy. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If you’re unsure, it’s best to consult with a doctor, especially for children under 24 pounds or under 2 years old.

Once you have the correct dose, you can take it every 6 to 8 hours if needed, but remember not to exceed 4 doses in a single day. Following these guidelines will help you use the medication safely and effectively.

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 heart surgery, as this could pose serious risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms may include hives, wheezing (asthma), skin redness, facial swelling, shock, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, especially in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for longer than recommended.

If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, persistent stomach pain, or signs of heart problems (like chest pain or difficulty breathing), seek medical attention immediately. It's important to consult a doctor before using ibuprofen if your child has a history of stomach issues, is dehydrated, or has other serious health conditions. Always monitor for any new or worsening symptoms during treatment.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, wheezing, skin reddening, facial swelling, shock, 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 have a severe sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. Do not use ibuprofen for more than two days in these cases or for children under three years old unless directed by a doctor.

If you suspect an overdose, contact a Poison Control Center immediately at 1-800-222-1222. You should also stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or slurred speech), or if your child does not feel better within 24 hours. If fever or pain worsens or lasts more than three days, or if new symptoms appear, seek medical advice.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific details about overdose symptoms or treatment in the available information, general signs of an overdose can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room for assistance. Remember, it's always better to be safe and get checked if you think something might be wrong.

Pregnancy Use

There are no specific guidelines or safety concerns mentioned regarding the use of ibuprofen during pregnancy. This means that the information provided does not indicate any contraindications (situations where the drug should not be used) or necessary dosage adjustments for pregnant individuals.

While the absence of warnings may seem reassuring, it's always best to consult with your healthcare provider before taking any medication during pregnancy. They can provide personalized advice based on your health and circumstances.

Lactation Use

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

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

Pediatric Use

When considering medication for your child aged 2 to 11 years, it's important to follow specific dosing guidelines based on their weight and age. For example, children weighing under 24 pounds or under 2 years old should have their dosage determined by a doctor. For those aged 2-3 years and weighing 24-35 pounds, the recommended dose is 5 mL, while children aged 4-5 years and weighing 36-47 pounds should receive 7.5 mL. As your child grows, the dosage increases, reaching 15 mL for an 11-year-old weighing 72-95 pounds.

Be cautious not to use this medication for more than 2 days or give it to children under 3 years old without a doctor's guidance. It's also crucial to be aware of potential allergic reactions, especially if your child is allergic to aspirin. Additionally, if your child has a history of stomach issues, dehydration, high blood pressure, or other serious health conditions, consult a doctor before use. Always check with a healthcare professional if your child is taking other medications or has any ongoing health concerns.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you are caring for an older adult, be attentive to any changes in their health or behavior after starting a new medication. Regular check-ins with a healthcare professional can help manage any potential risks and ensure the best outcomes.

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 certain medications can interact with each other, potentially leading to serious health issues. For instance, taking ibuprofen, a common pain reliever, alongside blood thinners (medications that prevent blood clots) or steroids can significantly increase the risk of severe stomach bleeding. Additionally, using nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, for longer than recommended can raise your chances of having a heart attack or stroke, except for aspirin, which has different effects.

If you or your child are taking any other medications, it's crucial to discuss this with your healthcare provider. They can help you understand any potential interactions and ensure that your treatment is safe and effective. Always prioritize open communication about your medications to protect your health.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance.

Before using the product, check that the carton is unopened and that the inner seal, marked "SEALED for YOUR PROTECTION," is intact. If the carton is opened or the seal is broken or missing, do not use the product, as this may compromise its safety. Always handle the product with care to ensure it remains in good condition.

Additional Information

You should take this medication orally. If you ever suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is GUARDIAN?

GUARDIAN is a children's ibuprofen oral suspension, classified as a nonsteroidal anti-inflammatory drug (NSAID).

What are the indications for using GUARDIAN?

GUARDIAN 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 dosage for GUARDIAN?

The dosage is 100 mg per 5 mL, and you should follow the dosing chart based on your child's weight or age.

What is the age range for using GUARDIAN?

GUARDIAN is intended for children aged 2 to 11 years.

How long does the effect of GUARDIAN last?

The effects of GUARDIAN can last up to 8 hours.

Are there any warnings associated with GUARDIAN?

Yes, GUARDIAN may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has certain health conditions.

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

If your child experiences symptoms like fainting, vomiting blood, or has black stools, stop use and seek medical help immediately.

Can I use GUARDIAN if my child has had an allergic reaction to ibuprofen?

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

How should I administer GUARDIAN?

Shake well before using and use only the enclosed dosing cup. Do not exceed 4 doses in a day.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Childrens Ibuprofen Blue Raspberry, Childrens Ibuprofen Bubblegum, Childrens Ibuprofen Fruit, Childrens Ibuprofen Grape.
Details

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Blue Raspberry, Childrens Ibuprofen Bubblegum, Childrens Ibuprofen Fruit, Childrens Ibuprofen Grape, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

GUARDIAN is an oral suspension formulation of children's ibuprofen, indicated for use in pediatric patients aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The product is designed to provide relief for up to 8 hours.

GUARDIAN is presented in a 4 FL OZ (120 mL) bottle and features a bubble gum flavor. It is formulated without artificial sweeteners and is alcohol-free. The National Drug Code (NDC) for this product is 53041-572-03.

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

The medication should be shaken well before use. It is imperative to utilize only the enclosed dosing cup for administration; 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 or, if weight is not available, their age.

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

If necessary, the dose may be repeated every 6-8 hours, but it is important not to exceed a total of 4 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 indicative of an allergic reaction may include hives, asthma (wheezing), skin reddening, facial swelling, shock, 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those concurrently using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

NSAIDs, with the exception of aspirin, are associated with 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 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. Consultation with a physician is advised if these symptoms occur. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if the child exhibits any of the following symptoms: signs of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), 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, redness or swelling in the affected area, or the emergence of any new symptoms.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, particularly in individuals with specific pre-existing conditions or those taking certain medications.

Severe allergic reactions may occur, especially in patients with a known allergy to aspirin. Symptoms of such reactions can include hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, and blisters.

The use of ibuprofen is associated with an increased risk of severe stomach bleeding, particularly 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 has been 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 longer than directed.

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 to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having 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, also warrant immediate medical attention. Furthermore, if a child does not achieve 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 consultation with a healthcare professional.

Before using ibuprofen, it is essential to consult a doctor if the child 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. Additionally, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has been associated with significant drug interactions that warrant careful consideration, particularly regarding its use with anticoagulants and corticosteroids.

Anticoagulants and Corticosteroids The concomitant use of ibuprofen with blood-thinning agents (anticoagulants) or steroid medications may increase the risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and to consider alternative pain management strategies if necessary.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The use of NSAIDs, including ibuprofen, has been linked to an elevated risk of cardiovascular events such as heart attack and stroke. This risk is particularly pronounced when these medications are used in higher doses or for extended periods. Clinicians should evaluate the necessity of NSAID therapy and consider the lowest effective dose for the shortest duration possible.

Pediatric Considerations In pediatric patients, it is essential to consult a healthcare provider if the child is taking any other medications, as potential drug interactions may occur. Monitoring for adverse effects and adjusting dosages may be necessary based on the child's overall medication regimen.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen Blue Raspberry, Childrens Ibuprofen Bubblegum, Childrens Ibuprofen Fruit, Childrens Ibuprofen Grape.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may be administered the medication according to the following dosing chart based on weight and age:

  • Under 24 lbs / Under 2 years: Consult a doctor

  • 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

It is important to note that the medication should not be used for more than 2 days or administered to children under 3 years of age unless directed by a healthcare professional.

Healthcare providers should be aware of potential allergy risks, as ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Additionally, there is a warning regarding stomach bleeding, which may be more likely in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using other NSAIDs.

There is also an increased risk of heart attack and stroke associated with NSAID use, excluding aspirin, particularly if the medication is used in excess or for prolonged periods.

Before administering this medication, healthcare professionals should inquire about the child's medical history, including any history of stomach issues, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke, asthma, or if the child is taking diuretics. Consultation with a doctor or pharmacist is advised if the child is under medical care for any serious condition or is taking other medications.

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. Additionally, the insert does not mention any safety concerns, contraindications, or dosage modifications related to pregnancy. Furthermore, no special precautions regarding the use of ibuprofen during pregnancy are provided. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on the management of overdosage cases. It is critical to provide comprehensive care tailored to the patient's needs, including potential interventions based on the clinical presentation.

In summary, due to the lack of specific overdosage information, a cautious and supportive approach is recommended, with an emphasis on monitoring and individualized patient 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that the medication be taken with food or milk if the child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, healthcare providers should inform patients to stop use and seek medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should be counseled to monitor the child’s response to treatment. If the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists for more than three days, they should contact a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a consultation with a doctor.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if any of the following apply: the stomach bleeding warning is relevant to the child; the child has a history of stomach issues such as heartburn; the child has experienced serious side effects from pain relievers or fever reducers; the child has not been adequately hydrated; the child has lost significant fluids due to vomiting or diarrhea; the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke; the child has asthma; or the child is taking a diuretic.

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

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to verify that the printed inner seal, marked "SEALED for YOUR PROTECTION," is intact before utilizing the product.

Storage conditions require the product to be maintained at a temperature range of 20-25°C (68-77°F) to ensure its efficacy and safety. Proper handling and adherence to these storage guidelines are crucial for maintaining product integrity.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients that in the event of an overdose, immediate medical assistance should be sought, or they should contact a Poison Control Center at 1-800-222-1222.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Blue Raspberry, Childrens Ibuprofen Bubblegum, Childrens Ibuprofen Fruit, Childrens Ibuprofen Grape, 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 Blue Raspberry, Childrens Ibuprofen Bubblegum, Childrens Ibuprofen Fruit, Childrens Ibuprofen Grape, 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.