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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 2021
Label revision date
August 13, 2021
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 2021
Label revision date
August 13, 2021
Manufacturer
Amazon. com Services LLC
Registration number
ANDA076359
NDC root
72288-763
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Drug Overview

Children’s Ibuprofen is a chewable pain reliever and fever reducer designed for children ages 2 to 11. Each 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 colds, flu, sore throats, headaches, and toothaches.

These dye-free, orange-flavored tablets are easy for kids to take, and they can last up to 8 hours for effective relief.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s 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 dosage instructions carefully and not exceed the recommended amount. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If you can, use weight for a more accurate dose; otherwise, age can be used.

If you need to take another dose, you can do so every 6 to 8 hours, but remember not to take more than four doses in a single day. For children under 2 years old or those weighing less than 24 pounds, it's best to consult a doctor before administering the medication. For those who are 2 to 3 years old or weigh between 24 and 35 pounds, the dose is 1 tablet. As the weight or age increases, the dosage will also increase, so be sure to check the chart to ensure you are taking the correct amount.

What to Avoid

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing, 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. Symptoms to watch for include chest pain, trouble breathing, weakness on one side of the body, slurred speech, and swelling in the legs. If your child experiences any signs of stomach bleeding, such as faintness, vomiting blood, or black stools, or if their symptoms worsen or do not improve within a few days, it’s important to consult a doctor immediately. Always seek medical advice if your child has any pre-existing 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, stop use and contact your doctor right away.

If you or your child has a severe sore throat with high fever, headache, nausea, or vomiting, consult a doctor promptly. Do not use ibuprofen for more than two days without medical advice, especially for children under three years old. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always consult your doctor if symptoms worsen or new symptoms appear.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult your healthcare provider to discuss any concerns and explore safer alternatives for pain relief or inflammation management during pregnancy. Your health and the health of your baby are the top priority, so always seek professional advice when considering medication.

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 on your nursing infant have not been thoroughly studied. Because of this uncertainty, you should carefully consider the benefits of using ibuprofen against any potential risks to your baby. Your healthcare provider can help you make an informed decision that prioritizes both your health and your infant's well-being.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11, the dosage depends on their weight. For example, if your child weighs between 24-35 pounds and is 2-3 years old, they can take 1 tablet. If they weigh 36-47 pounds and are 4-5 years old, the dose increases to 1 ½ tablets.

Make sure to follow the dosing guidelines carefully, repeating the dose every 6-8 hours if necessary, but do not exceed 4 doses in a day. It's best to use your child's weight for dosing, but if that's not possible, you can use their age instead. Remember to chew or crush the tablets completely before swallowing to ensure they are effective.

Geriatric Use

While there is no specific information about the use of Basic Care Children's Ibuprofen in older adults, it's important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this medication. They can provide guidance tailored to your individual health needs and any potential interactions with other medications you may be taking. Always prioritize safety and ensure that any treatment plan is appropriate for your situation.

Renal Impairment

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

Hepatic Impairment

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

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

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications. For instance, if you take blood thinners (medications that help prevent blood clots) or steroids, using ibuprofen may increase your risk of stomach bleeding. Additionally, taking ibuprofen, especially in higher doses or for extended periods, can raise the chances of serious heart issues like heart attack or stroke. You should also avoid using ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, as this can lead to further complications.

Always discuss any medications you are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

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 helps maintain its effectiveness and safety.

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 indicate that it is no longer safe to use. Always prioritize these storage and handling guidelines to ensure your safety and the product's reliability.

Additional Information

No further information is available.

FAQ

What is Children's Ibuprofen?

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

What does Children's Ibuprofen do?

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

How should I administer Children's Ibuprofen?

You should chew or crush the tablets completely before swallowing and follow the dosing chart based on your child's weight or age.

What is the maximum dosage for Children's Ibuprofen?

Do not use more than 4 times a day and repeat doses every 6-8 hours if needed.

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/fever reducer, or right before or after heart surgery.

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

Stop use and ask a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can I use Children's Ibuprofen if my child has high blood pressure or heart disease?

Consult a doctor before use if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke.

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 during the third trimester.

What should nursing mothers know about Children's Ibuprofen?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk and its effects on nursing infants are not well studied.

What are the storage instructions for Children's Ibuprofen?

Store 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 as a pain reliever and fever reducer, providing effects that may last up to 8 hours. These tablets are dye-free and feature an orange flavor, making them suitable for pediatric use. Each package contains 24 orange-flavored chewable tablets.

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. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage. The appropriate dose can be determined using the dosing chart provided below; weight is the preferred method for dosing, but age may be used if weight is not available.

If necessary, the dose may be repeated every 6 to 8 hours, but it is important to note that the medication should not be administered more than four times in a 24-hour period.

Dosing Chart:

Weight (lb):

  • Under 24: Consult a physician

  • 24-35: 1 tablet

  • 36-47: 1 ½ tablets

  • 48-59: 2 tablets

  • 60-71: 2 ½ tablets

  • 72-95: 3 tablets

Age (yr):

  • Under 2: Consult a physician

  • 2-3: 1 tablet

  • 4-5: 1 ½ tablets

  • 6-8: 2 tablets

  • 9-10: 2 ½ tablets

  • 11: 3 tablets

It is essential to adhere strictly to the dosing recommendations to ensure patient safety and efficacy of treatment.

Contraindications

Use is contraindicated in children with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

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 an increased 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 may further elevate this risk.

NSAIDs, excluding aspirin, are known to increase the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. The 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 administered for more than two days, nor should it be given 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 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 alert for the emergence of any new symptoms and seek medical advice accordingly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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 warning for potential severe stomach bleeding. The risk of this adverse reaction 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.

Patients should also be aware of the 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 prolonged durations.

In clinical settings, patients presenting with severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, should be evaluated promptly, as these symptoms may indicate a serious condition. It is advised not to use ibuprofen for more than two days in such cases or to administer it to children under three years of age without medical guidance.

Patients are advised to discontinue use and consult a healthcare professional if they experience 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 attention. Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

Before using ibuprofen, it is essential for patients to consult a doctor if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical advice prior to use. Additionally, patients with asthma or those taking diuretics should consult a healthcare professional before using this medication.

Lastly, it is recommended that patients under a doctor's care for any serious condition or those taking other medications discuss their use of ibuprofen with a healthcare provider or pharmacist.

Drug Interactions

Ibuprofen may interact with various drug classes, leading to significant clinical effects.

Pharmacodynamic Interactions:

Ibuprofen has the potential to increase the risk of gastrointestinal bleeding when administered concurrently with anticoagulants or steroid medications. Healthcare professionals should monitor patients closely for signs of gastrointestinal distress and consider alternative pain management strategies if necessary.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may elevate the risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used at higher doses or for extended periods. It is advisable to use the lowest effective dose for the shortest duration necessary to mitigate these risks.

Pharmacokinetic Interactions:

Ibuprofen should not be co-administered with other medications containing NSAIDs, whether prescription or nonprescription, such as aspirin or naproxen. The concomitant use of these agents may lead to an increased risk of adverse effects without providing additional therapeutic benefit.

No specific laboratory test interactions have been identified in the available data.

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 healthcare professional. For children aged 2 to 11 years, dosing is based on weight when possible; otherwise, age may be used. The recommended dosages are as follows:

  • For children under 24 lb (under 2 years): consult a doctor.

  • For children weighing 24-35 lb (2-3 years): 1 tablet.

  • For children weighing 36-47 lb (4-5 years): 1 ½ tablets.

  • For children weighing 48-59 lb (6-8 years): 2 tablets.

  • For children weighing 60-71 lb (9-10 years): 2 ½ tablets.

  • For children weighing 72-95 lb (11 years): 3 tablets.

Doses may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. Tablets should be chewed or crushed completely before swallowing to ensure proper administration.

Geriatric Use

There is no specific information regarding the use of Basic Care Children's Ibuprofen in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the administration of this medication to elderly patients, as the absence of data necessitates careful monitoring and individualized assessment of potential risks and benefits.

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

Hepatic Impairment

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

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

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

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate 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 help 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 effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified 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 routine pharmacovigilance activities.

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 crucial to 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, patients should be cautioned against using this product right before or after heart surgery.

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 persistent stomach pain. Furthermore, they should 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.

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

When using this product, patients may experience mouth or throat burning; therefore, it is advisable to administer it with food or water. If stomach upset occurs, taking the medication with food or milk is recommended.

Patients should be encouraged to consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues such as heartburn. It is also important 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.

Additionally, healthcare providers should recommend consulting a doctor before use if the child has 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. Lastly, it is prudent for patients to consult a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure its stability 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 compromise of the product's integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

No further data are available.

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.