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Basic Care Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
September 7, 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
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 7, 2021
Manufacturer
Amazon. com Services LLC
Registration number
ANDA074937
NDC root
72288-897
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

Children’s Ibuprofen is an oral suspension medication designed for children aged 2 to 11 years. It serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. As a nonsteroidal anti-inflammatory drug (NSAID), it works by reducing inflammation and providing relief that can last up to 8 hours.

This medication is alcohol-free and comes in a pleasant berry flavor, making it easier for children to take. It is available in an 8 FL OZ (240 mL) bottle, providing a convenient option for parents looking to manage their child's discomfort and fever effectively.

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 is 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.

Dosage and Administration

Before using this product, it's important to note that it does not come with complete directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You should find the right dose by referring to the dosing chart provided, which is based on weight. If weight is not available, you can use age as a guide.

Use the enclosed dosing cup to measure the medication accurately; do not use any other device. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. After using the dosing cup, wash it thoroughly to keep it clean. Finally, always replace the original bottle cap to ensure it remains child-resistant and safe. If your child weighs under 24 pounds (or is under 2 years old), consult a doctor for guidance.

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 safety by following these guidelines closely. If you have any concerns or questions about your child's health or 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 check with a healthcare professional 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, asthma (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 2 days without a doctor's guidance, especially if they are under 3 years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 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

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, because it may harm the developing fetus. Potential risks include cardiovascular problems and kidney issues for the baby.

Before taking ibuprofen, you should always consult your healthcare provider, particularly if you are in the later stages of your pregnancy. They can help you understand the best options for managing any discomfort you may experience.

Lactation Use

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

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

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 10 years, the dosage depends on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, consult a doctor first. If they weigh between 24-35 lbs and are 2-3 years old, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 lbs), 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for an 11-year-old (72-95 lbs).

Always use the enclosed dosing cup to measure the medication, and do not exceed four doses in a day, with each dose taken every 6-8 hours. Keep the medication out of reach of children, and in case of an overdose, seek medical help immediately. It's important to consult a doctor if your child has a history of stomach issues, dehydration, or any serious health conditions, such as high blood pressure or kidney disease, or if they are taking certain medications.

Geriatric Use

When considering this medication, it's important to note that it does not provide specific directions or complete warnings for adult use, including older adults. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for personalized guidance.

Always ensure that any medication is appropriate for your health needs, especially if there are concerns about age-related changes in health or medication tolerance. Your healthcare provider can help determine the right dosage and monitor for any potential side effects.

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 doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (blood tests that check how well your liver is working) 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, using ibuprofen, especially in higher doses or for extended periods, can raise the risk of serious heart issues like heart attack, heart failure, and stroke. You should also avoid taking 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 for your health needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure a safe experience.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. It's important to keep this 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.

To avoid stomach upset, consider taking the medication with food or milk. Always use the enclosed dosing cup for measuring your dose, and make sure to shake the bottle well before use. Do not use the medication if the printed neckband is broken or missing, and store it at room temperature (20-25°C or 68-77°F). Avoid freezing the medication.

FAQ

What is Children's Ibuprofen?

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

What age group can use Children's Ibuprofen?

Children's Ibuprofen is intended for children aged 2 to 11 years.

How does Children's Ibuprofen work?

Children's Ibuprofen works as a nonsteroidal anti-inflammatory drug (NSAID) to relieve pain and reduce fever, lasting up to 8 hours.

What are the indications for using Children's Ibuprofen?

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

What should I do if my child has a history of allergies?

Do not use Children's Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What are the dosing instructions for Children's Ibuprofen?

Dosing is based on weight; for example, a child weighing 24-35 lbs (2-3 years) should receive 5 mL. Always use the enclosed dosing cup.

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.

What should I do if my child experiences side effects?

If your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours, 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 precautions should I take when using Children's Ibuprofen?

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

How should I store Children's Ibuprofen?

Store Children's Ibuprofen at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact.

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 an oral suspension formulated to provide pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is alcohol-free and features a berry flavor for palatability. It is packaged in an 8 fluid ounce (240 mL) bottle, with effects lasting up to 8 hours.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to consult a physician for patients weighing under 24 lbs (under 2 years of age).

For patients weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Patients weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be administered 12.5 mL. Finally, for patients weighing 72-95 lbs (11 years), the appropriate dose is 15 mL.

Dosing should be performed using only the enclosed dosing cup; other dosing devices are not recommended. It is crucial to shake the product well before each use. If necessary, doses may be repeated every 6-8 hours, but the total daily administration should not exceed four doses. After each use, the dosing cup should be washed thoroughly.

To maintain child resistance, the original bottle cap must be replaced securely after each use. Healthcare professionals should ensure that patients and caregivers are aware of these instructions to promote safe and effective use of the product.

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, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment may further elevate this risk.

NSAIDs, with the exception of aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified 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, particularly 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 to children under three years of age, unless directed by a healthcare provider.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive 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; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In cases of overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay (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 warning for the potential 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 a significant risk associated with the use of NSAIDs, excluding aspirin, for heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the directed dosage or duration.

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 consultation. 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.

In the event of any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, patients should discontinue use and seek medical advice immediately. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant urgent 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 consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

Before using ibuprofen, it is essential for patients to consult a doctor if any of the following apply: a history of stomach bleeding, previous serious side effects from pain relievers or fever reducers, dehydration due to vomiting or diarrhea, or pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. It is also advisable to consult a doctor or pharmacist if the patient is under care for any serious condition or is taking other medications.

Drug Interactions

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

Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies where appropriate.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Ibuprofen should not be administered alongside other NSAIDs, whether prescription or nonprescription, such as aspirin or naproxen. The combined use of these agents can increase the risk of adverse effects, including gastrointestinal complications.

Cardiovascular Risks The use of ibuprofen, particularly at higher doses or for extended periods, may heighten the risk of serious cardiovascular events, including heart attack, heart failure, and stroke. Clinicians should evaluate the necessity of ibuprofen therapy in patients with existing cardiovascular conditions and consider alternative pain management strategies when appropriate.

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 doctor. For dosing, the following guidelines apply based on weight and age:

  • For patients weighing under 24 lbs (under 2 years of age), consultation with a doctor is required.

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

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

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

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

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

It is essential to use only the enclosed dosing cup and not any other dosing device. Doses may be repeated every 6-8 hours, but should not exceed 4 doses in a 24-hour period.

This medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, such as heartburn, or has experienced an allergic reaction to ibuprofen or any other pain reliever/fever reducer. Additionally, consultation is recommended if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea, or if there are concerns regarding high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. It is also important to consult a doctor if the child is taking a diuretic or is under care for any serious condition.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is essential to evaluate the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of ibuprofen during pregnancy may pose risks to the fetus, including potential cardiovascular issues and renal impairment. Pregnant women should consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy.

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 monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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 liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications and may require more frequent clinical assessments to monitor for any signs of hepatic decompensation. It is crucial to tailor treatment plans based on the severity of hepatic impairment to optimize outcomes while minimizing risks.

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 symptoms may vary depending on the substance involved. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate appropriate management procedures based on the clinical presentation and the specific agent involved in the overdose.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to implement standard protocols for overdose management, which may include decontamination, symptomatic treatment, and, if applicable, the use of antidotes.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include hives, facial swelling, asthma characterized by wheezing, shock, skin reddening, rash, and blisters.

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 to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to ask a doctor before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Patients should also be advised to consult a healthcare professional if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke. If the child has asthma or is taking a diuretic, a discussion with a doctor prior to use is essential.

Furthermore, healthcare providers should recommend that patients speak with a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications. This ensures safe and effective use of the medication while minimizing potential risks.

Storage and Handling

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

Freezing the product is strictly prohibited, as it may compromise its quality. Additionally, healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for ensuring the product's effectiveness.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs. It is essential to use only the enclosed dosing cup for administration and to shake the product well before use.

Patients should be counseled to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Additionally, the product should not be used if the printed neckband is broken or missing, and it should be stored at a temperature of 20-25°C (68-77°F), avoiding freezing.

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

Last AI update:

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.