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Basic Care Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
September 9, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
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 2020
Label revision date
September 9, 2020
Manufacturer
Amazon. com Services LLC
Registration number
ANDA076359
NDC root
72288-521
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

Children’s Ibuprofen is a chewable pain reliever and fever reducer designed for children ages 2 to 11. Each grape-flavored tablet contains 100 mg of ibuprofen, which is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing fever and relieving minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

This medication is available in a convenient chewable form, making it easier for children to take. It provides relief that can last up to 8 hours, helping to keep your child comfortable during times of illness.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, as this product does not provide complete warnings for adult use. Always check the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age instead.

For children under 24 pounds or under 2 years old, it's best to consult a doctor before giving this medication. For those weighing between 24 to 35 pounds (ages 2-3 years), the recommended dose is 1 tablet. If your child weighs between 36 to 47 pounds (ages 4-5 years), they should take 1 ½ tablets. For children weighing 48 to 59 pounds (ages 6-8 years), the dose is 2 tablets, and for those weighing 60 to 71 pounds (ages 9-10 years), it's 2 ½ tablets. Finally, if your child weighs 72 to 95 pounds (age 11 years), they should take 3 tablets.

If you need to give another dose, you can repeat it every 6 to 8 hours, but do not exceed 4 doses in a single day. Always ensure you do not give more than the directed amount.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize your child's safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult with a healthcare professional for personalized advice.

Side Effects

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

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always discuss with a healthcare provider before use if your child has any underlying health conditions 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 the medication 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, or if you experience symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, consult a doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

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

Pregnancy Use

The safety of ibuprofen during pregnancy has not been established, and it is generally not recommended, especially in the third trimester (the final three months of pregnancy). Using ibuprofen while pregnant may pose risks to your developing baby, including potential cardiovascular effects.

If you are pregnant or planning to become pregnant, it’s important to consult your healthcare provider before using ibuprofen. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this time.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, and the effects of ibuprofen on nursing infants haven't been thoroughly studied. Because of this uncertainty, you should carefully consider the benefits of using ibuprofen against any potential risks to your baby. Always prioritize your health and your baby's well-being when making decisions about medication while breastfeeding.

Pediatric Use

It's important to be cautious when giving medication to children. For children under 3 years old, you should only use this medication if directed by a doctor. If your child is between 2 and 3 years old and weighs between 24-35 pounds, they can take 1 tablet. For children aged 4-5 years who weigh 36-47 pounds, the dose is 1 ½ tablets, and so on, with specific dosages based on weight and age up to 11 years old. Remember, do not use this medication for more than 2 days without consulting a doctor.

Always keep the medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Before giving this medication, check with your doctor if your child has any history of allergies, stomach issues, or other serious health conditions. It's also a good idea to give the medication with food or milk to prevent stomach upset and to stop use if you notice any signs of stomach bleeding or heart problems.

Geriatric Use

When it comes to using Basic Care Children's Ibuprofen, there are no specific guidelines or dosage adjustments for older adults mentioned in the drug insert. This means that, generally, elderly patients can use this medication without special considerations or safety concerns related to their age.

However, as with any medication, it's always a good idea for you or your caregivers to consult with a healthcare professional before starting any new treatment, especially if there are existing health conditions or other medications involved. This ensures that the medication is safe and appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

Hepatic Impairment

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

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

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

Always consult with your healthcare provider if your child is taking any other medications, especially if they have asthma or are on diuretics (medications that help remove excess fluid from the body). Discussing all medications and health conditions with a doctor can help ensure your child's safety and well-being.

Storage and Handling

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

When handling the product, be sure to check that the printed seal under the cap is intact. If the seal is broken or missing, do not use the product, as this may compromise its safety and effectiveness. Always prioritize these storage and handling guidelines to ensure your safety and the product's reliability.

Additional Information

You should take this medication orally, making sure to chew or crush the tablets completely before swallowing. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. To help prevent mouth or throat burning, consider taking it with food or water, and if you experience stomach upset, taking it with food or milk may help.

It's important to keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is a chewable pain reliever and fever reducer available in 100 mg grape-flavored tablets for children ages 2 to 11.

How does Children's Ibuprofen work?

It reduces fever and relieves minor aches and pains associated with the common cold, flu, sore throat, headaches, and toothaches.

What is the recommended dosage for Children's Ibuprofen?

Dosage is based on weight or age. For example, children weighing 24-35 lb (ages 2-3 years) should take 1 tablet.

How often can I give Children's Ibuprofen?

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

Are there any contraindications for using Children's Ibuprofen?

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

What should I do if my child experiences side effects?

If your child shows signs of stomach bleeding or symptoms of heart problems, stop use and consult a doctor immediately.

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

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated, especially in the third trimester.

Can nursing mothers use Children's Ibuprofen?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

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

Packaging Info

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

Packaging configurations for Basic Care Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Basic Care 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 is a nonsteroidal anti-inflammatory drug (NSAID) formulated as chewable tablets, each containing 100 mg of ibuprofen. The product is designed for pain relief and fever reduction in children aged 2 to 11 years. Each bottle contains 24 grape-flavored tablets, which are intended to be chewed or crushed completely before swallowing. The effects of the medication can last up to 8 hours. This formulation is comparable to the active ingredient found in Children’s Motrin®.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. This product does not provide directions or complete warnings for adult use. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage.

Dosing should be determined using the chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as an alternative. Doses may be repeated every 6 to 8 hours as needed, but should not exceed four doses in a 24-hour period.

Dosing Chart:

  • For patients weighing under 24 lb or under 2 years of age, consult a doctor for appropriate dosing.

  • For patients weighing 24-35 lb or aged 2-3 years, administer 1 tablet.

  • For patients weighing 36-47 lb or aged 4-5 years, administer 1 ½ tablets.

  • For patients weighing 48-59 lb or aged 6-8 years, administer 2 tablets.

  • For patients weighing 60-71 lb or aged 9-10 years, administer 2 ½ tablets.

  • For patients weighing 72-95 lb or aged 11 years, administer 3 tablets.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response 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 an increased risk of severe stomach bleeding. The likelihood of such an event 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 similar agents). Additionally, exceeding the recommended dosage or duration of treatment may further elevate this risk.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to 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 prolonged periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. 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 physician.

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

In the event of an overdose, it is critical to obtain emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk 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 and naproxen. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

There is also an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess or for longer durations than directed.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical attention. 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 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 consultation. Furthermore, 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 any new symptoms should also prompt a consultation.

Before using ibuprofen, it is essential for patients to consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is advised for patients with dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also recommended that patients under a doctor's care for any serious condition or those taking other medications seek guidance prior to use.

Drug Interactions

Ibuprofen is associated with a risk of severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the use of ibuprofen in pediatric patients, it is important to note that the concomitant use of blood thinners (anticoagulants) or steroid medications may significantly increase the risk of gastrointestinal bleeding. Additionally, the risk of stomach bleeding is further elevated if the child is concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen.

In cases where the child has asthma and is also prescribed a diuretic, careful monitoring is advised. It is recommended that healthcare providers be consulted if the child is taking any other medications to ensure safe and effective use of ibuprofen.

Packaging & NDC

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

Packaging configurations for Basic Care Childrens Ibuprofen.
Details

Pediatric Use

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

  • For children weighing under 24 lb and under 2 years of age, consultation with a doctor is required.

  • For children weighing 24-35 lb and aged 2-3 years, the recommended dose is 1 tablet.

  • For children weighing 36-47 lb and aged 4-5 years, the recommended dose is 1 ½ tablets.

  • For children weighing 48-59 lb and aged 6-8 years, the recommended dose is 2 tablets.

  • For children weighing 60-71 lb and aged 9-10 years, the recommended dose is 2 ½ tablets.

  • For children weighing 72-95 lb and aged 11 years, the recommended dose is 3 tablets.

This medication should not be used for more than 2 days in pediatric patients without medical advice. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Before administering this medication, healthcare professionals should inquire if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, stomach issues such as heartburn, or serious side effects from pain relievers. Additional caution is warranted for children who have not been drinking fluids, have lost significant fluid due to vomiting or diarrhea, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke, asthma, or are taking diuretics or other medications.

Mouth or throat burning may occur; therefore, it is advisable to administer the medication with food or water. If stomach upset occurs, taking the medication with food or milk is recommended. Parents and caregivers should be instructed to stop use and consult a doctor if the child exhibits any signs of stomach bleeding or symptoms indicative of heart problems or stroke.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Basic Care Children's Ibuprofen. As such, healthcare providers may not need to implement additional precautions or modifications when prescribing this medication to geriatric patients. However, it is always advisable to monitor elderly patients for any potential adverse effects, given the general increased sensitivity of this population to medications.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Women who are pregnant or planning to become pregnant should consult a healthcare provider before using ibuprofen to discuss the potential risks and benefits.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to weigh the benefits against the potential risks when considering ibuprofen use while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of 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 therapeutic approach for those with hepatic impairment.

Overdosage

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

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and should be considered when evaluating the safety profile of the product.

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.

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.

It is important to counsel patients to discontinue use and consult a doctor 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. Patients should also be advised to seek medical attention if there is any redness or swelling in the area of pain, or if any new symptoms arise.

When using this product, patients should be made aware that mouth or throat burning may occur; therefore, it is recommended to administer the medication with food or water. If stomach upset occurs, taking the product with food or milk may help alleviate discomfort.

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

Furthermore, patients should be counseled to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. If the child has asthma or is taking a diuretic, it is crucial to seek medical advice prior to use. Lastly, patients should be encouraged to consult a doctor or pharmacist 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 configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

The medication is administered orally, with tablets required to be chewed or crushed completely before swallowing. Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period.

Patients should be counseled that mouth or throat burning may occur, and it is advisable to take the medication with food or water to mitigate this effect. If stomach upset occurs, taking the medication with food or milk is recommended. Clinicians should ensure that patients keep the medication out of reach of children and advise them to seek medical assistance or contact a Poison Control Center immediately in the event of an overdose.

Drug Information (PDF)

This file contains official product information for Basic Care 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 Basic Care 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.

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.