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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 2021
Label revision date
June 5, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
June 5, 2025
Manufacturer
Amazon. com Services LLC
Registration number
ANDA074937
NDC root
72288-660
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 Oral Suspension is a medication designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

This alcohol-free suspension comes in a pleasant grape flavor, making it easier for children to take. If your child is experiencing discomfort or fever, this medication may be a suitable option to help them feel better.

Uses

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

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus if taken during pregnancy.

Dosage and Administration

Before using this product, it's important to know that it doesn't 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, which is based on your child's weight or age.

Use the enclosed dosing cup to measure the dose accurately; do not use any other device. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times a day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. If your child weighs less than 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24 and 95 pounds, the dosing chart provides specific amounts to use based on their weight.

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.

Be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Dependence (a condition where the body becomes reliant on a substance) can also occur, so it's crucial to follow these guidelines closely to ensure your child's safety.

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 (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, heart failure, 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 they do not find relief within 24 hours, it’s important to consult a doctor immediately. Always seek medical advice 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 ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get 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 particularly contraindicated (not recommended) during the third trimester. Using ibuprofen while pregnant may pose risks to your fetus, including potential cardiovascular effects.

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

Lactation Use

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

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

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years old unless a doctor specifically advises you to do so. For children aged 2 to 10 years, the dosage depends on their weight and age. For example, a child weighing between 24-35 pounds (about 2-3 years old) should receive 5 mL, while a child weighing 72-95 pounds (11 years old) should receive 15 mL. Always use the enclosed dosing cup for accurate measurement and avoid using any other devices.

Make sure to keep this medication out of reach of children and do not use it for more than 2 days without consulting a doctor. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 specific guidelines or adjustments based on your kidney health. Always prioritize open communication with your healthcare provider to ensure your safety and well-being.

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 will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these 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 taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. 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 other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen are being used.

Using ibuprofen can also raise the chances of serious heart issues, such as heart attack or stroke, especially if taken in higher doses or for longer than recommended. Always consult with a healthcare provider before starting ibuprofen or if your child is taking any other medications, to ensure safety and avoid harmful interactions.

Storage and Handling

To ensure the safety and effectiveness 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 indicate a safety issue.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your product.

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 four 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.

Before using the medication, shake the bottle well and use only the enclosed dosing cup to measure your dose. Make sure to find the correct dose on the provided chart, using weight if possible; otherwise, use age. After each use, wash the dosing cup thoroughly. Do not use the medication if the printed neckband is broken or missing, and store it at room temperature between 20-25°C (68-77°F). Avoid freezing the medication.

FAQ

What is Children's Ibuprofen Oral Suspension used for?

Children's Ibuprofen Oral Suspension is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What is the active ingredient in Children's Ibuprofen Oral Suspension?

The active ingredient is ibuprofen, which is a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce fever.

What is the recommended dosage for children aged 2-3 years?

For children aged 2-3 years weighing 24-35 lbs, the recommended dose is 5 mL.

How often can I give Children's Ibuprofen Oral Suspension?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any contraindications for using this medication?

Do not use Children's Ibuprofen Oral Suspension if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or if they are about to undergo heart surgery.

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor immediately.

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

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

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen Oral Suspension?

Store the medication at 20-25°C (68-77°F) and do not freeze it. Ensure the printed neckband is intact.

Can I use any dosing device for Children's Ibuprofen Oral Suspension?

You should only use the enclosed dosing cup and not any other dosing device to ensure accurate dosing.

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 Oral Suspension contains 100 mg of ibuprofen per 5 mL. This formulation serves as a nonsteroidal anti-inflammatory drug (NSAID) that acts as both a pain reliever and a fever reducer. The product is alcohol-free and is flavored with grape. It is packaged in a 4 FL OZ (118 mL) bottle.

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 dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dosage. For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose is 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. For patients weighing 72-95 lbs (11 years), the dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. 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. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use 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 children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, elevate the 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 extended periods.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should advise caregivers to discontinue use and seek medical attention 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 new symptoms that arise should also prompt a discussion with a healthcare professional.

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

Side Effects

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

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

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.

Patients should also be informed 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 longer durations than prescribed.

In pediatric patients, a severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition requiring prompt medical consultation. 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 a doctor's direction.

Patients should discontinue use and seek medical advice 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 there is no 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 crucial for patients to consult a doctor if any of the following apply: a history of stomach problems, such as heartburn; 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 healthcare professional 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.

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

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Additionally, the risk of stomach bleeding is elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Monitoring for gastrointestinal symptoms is advised in patients receiving these combinations.

Cardiovascular Risks There is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, associated with ibuprofen, particularly when used in higher doses or for extended periods. Healthcare providers should evaluate the necessity of ibuprofen therapy and consider alternative treatments when appropriate.

Consultation Recommendations It is recommended that healthcare providers consult with a physician if the patient is taking any other medications. This ensures a comprehensive review of potential interactions and appropriate management strategies.

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 children aged 2 to 11 years, dosing is based on weight and age, as outlined in the following chart:

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

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

Dosing should be performed using the enclosed dosing cup; other dosing devices are not recommended. It is advised to use weight for dosing whenever possible; otherwise, age may be used as a guide.

The medication should not be used for more than 2 days in pediatric patients. In case of overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Additionally, this product should be kept out of reach of children.

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 potential risks to the fetus. The use of ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options. It is essential for healthcare professionals to consider these factors when prescribing medications to pregnant patients.

Lactation

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

Renal Impairment

Patients with renal impairment 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, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to adjust the dosage as needed.

Additionally, patients with a history of significant comorbidities such as high blood pressure, heart disease, kidney disease, or a history of stroke should be monitored closely, as these conditions may further complicate the management of their 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. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Reports of the following adverse reactions have been received during postmarketing use of ibuprofen.

Allergic reactions have been documented, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding, heart attack, and stroke have been reported. These events were identified through voluntary reporting and surveillance programs.

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 adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

Patients should also be advised to consult a healthcare professional if the child has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of 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 consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is currently 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 configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, ensuring that only intact and properly sealed items are utilized.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to shake the medication well before use and to utilize only the enclosed dosing cup for accurate measurement, ensuring that the correct dose is determined based on the provided chart, preferably using the patient's weight or age.

It is crucial 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. Patients should also be instructed to wash the dosing cup after each use and to avoid using the medication if the printed neckband is broken or missing. Proper storage conditions include maintaining the medication at 20-25°C (68-77°F) and 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

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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.