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Care One 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 2004
Label revision date
June 13, 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 2004
Label revision date
June 13, 2025
Manufacturer
American Sales Company
Registration number
ANDA074937
NDC root
41520-166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

CAREone® is a children's ibuprofen (a type of medication that helps relieve pain and reduce fever) oral suspension designed for children aged 2 to 11 years. It comes in a bubble gum flavor and is alcohol-free and gluten-free. This medication is effective in relieving minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, and it can also help reduce fever. The effects of CAREone® can last for up to 8 hours, providing your child with much-needed comfort.

Uses

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

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with specific 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; avoid using any other device. If necessary, you can repeat the dose every 6 to 8 hours, but do not use it more than four times a day. After each use, wash the dosing cup to keep it clean, and remember to replace the original bottle cap to ensure it remains child-resistant. If your child weighs under 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24 to 95 pounds, the dosing chart provides specific amounts to use based on their weight.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. 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, or leg swelling. 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 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 a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, consult a doctor. In case of an overdose, seek 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

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no stated contraindications (conditions that would make the use of a drug inadvisable) or special precautions for pregnant individuals. Additionally, the text does not provide any recommendations for dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

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 particular considerations or precautions you need to take when using this medication during lactation (the period of breastfeeding).

Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding, but based on the current information, ibuprofen appears to be safe for nursing mothers.

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 years, the dosage depends on their weight and age. For example, a child weighing between 24-35 pounds (about 2-3 years old) can take 5 mL, while a child weighing 72-95 pounds (11 years old) can take 15 mL. Always consult a doctor if your child has a history of stomach issues, heart disease, asthma, or is taking other medications.

Make sure to monitor your child closely. If they have not been drinking fluids, are experiencing vomiting or diarrhea, or if you notice any serious side effects, contact a doctor immediately. This medication should not be used for more than 2 days without medical advice, and doses can be repeated every 6-8 hours, but not more than 4 times a day. Always keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center right away.

Geriatric Use

When it comes to using this product for older adults, there isn't specific information available about its use in this age group. This means that the product may not have been tested thoroughly in older patients, and there are no detailed guidelines or warnings tailored for their needs.

If you are caring for an older adult, it's important to consult with a healthcare professional before starting this medication. They can provide guidance based on the individual's health status and any other medications they may be taking. Always prioritize safety and ensure that any treatment plan is appropriate for their unique 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 may suggest adjustments to your dosage or additional monitoring based on your specific health needs. Always prioritize open communication with your doctor regarding your kidney health and any other medical conditions you may have.

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 health and treatment. Conditions like high blood pressure, heart disease, and kidney disease can complicate your situation, so close monitoring is essential.

You should discuss any existing liver issues with your healthcare provider, as they may need to adjust your medication dosages or monitor your liver function tests (blood tests that check how well your liver is working) more frequently. Always keep your doctor informed about your health history, including any strokes or other significant medical events, to ensure you receive the safest and most effective care.

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Additionally, if your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if your child is using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

To ensure your child's safety, always consult with a healthcare provider before starting ibuprofen or any other medication. Discussing all medications your child is taking, including over-the-counter drugs, is crucial to avoid potential interactions and complications.

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 safety.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its effectiveness.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup for accurate measurement, and make sure to wash it after each use.

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

FAQ

What is CAREone®?

CAREone® is an oral suspension containing ibuprofen, designed for children ages 2 to 11 years, and is used as a pain reliever and fever reducer.

How should I dose CAREone®?

Use the enclosed dosing cup to measure the dose based on your child's weight or age. Do not exceed 4 doses in a day.

What are the indications for using CAREone®?

CAREone® relieves minor aches and pains from the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

Are there any warnings associated with CAREone®?

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

Can I give CAREone® to my child if they are under 2 years old?

You should ask a doctor before giving CAREone® to children under 2 years old.

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

If your child feels faint, vomits blood, or has bloody or black stools, stop use and seek medical help immediately.

Is CAREone® safe to use during pregnancy or while breastfeeding?

The provided information does not specify any risks or recommendations for use during pregnancy or breastfeeding.

How should I store CAREone®?

Store CAREone® at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

What flavor does CAREone® come in?

CAREone® is available in a bubble gum flavor.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Care One Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Care One Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

CAREone® is an oral suspension formulation containing Children’s IBUPROFEN, designed for pediatric use in children aged 2 to 11 years. Each 5 mL dose delivers 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) effective as a pain reliever and fever reducer. The product is alcohol-free and gluten-free, with a bubble gum flavor to enhance palatability. The suspension is packaged in a 4 FL OZ (118 mL) bottle, and a dosage cup is included for accurate administration. The analgesic and antipyretic effects of this formulation can last 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 specific dosing instructions must be followed. Healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight or age.

Prior to administration, the product must be shaken well. The enclosed dosing cup should be used exclusively for measuring the dose; no other dosing devices should be utilized. The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of 4 doses per day.

The dosing chart is as follows:

  • For patients weighing under 24 lbs or under 2 years of age, the dose should be determined by consulting a physician.

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

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

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

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

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

It is imperative to replace the original bottle cap after each use to maintain child resistance. Additionally, the dosing cup should be washed thoroughly after each use to ensure proper hygiene and prevent cross-contamination. Dosing may also be adjusted as directed by a healthcare professional.

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 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 carries a 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.

NSAIDs, with the exception of aspirin, are associated with 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. Consultation with a physician is advised in such cases. Additionally, ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a healthcare provider.

It is crucial to advise patients 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 indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

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, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, 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 direction.

Patients are instructed to 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 experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if a 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 consult a healthcare professional. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a medical evaluation.

Before using ibuprofen, it is essential for patients to consult a healthcare provider if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have 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 recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional or pharmacist before using ibuprofen.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to patients with such allergies.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further amplified when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen, especially those who are concurrently taking anticoagulants, steroids, or other NSAIDs. Additionally, consultation with a healthcare professional is recommended if the patient is taking any other medications, to ensure safe and effective use of ibuprofen.

Packaging & NDC

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

Packaging configurations for Care One 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 10 years, dosing is based on weight and age as follows: for those under 24 lbs (under 2 years), consultation with a doctor is required; for 24-35 lbs (2-3 years), the dose is 5 mL; for 36-47 lbs (4-5 years), the dose is 7.5 mL; for 48-59 lbs (6-8 years), the dose is 10 mL; for 60-71 lbs (9-10 years), the dose is 12.5 mL; and for 72-95 lbs (11 years), the dose is 15 mL.

Dosing may be repeated every 6-8 hours, but should not exceed 4 doses in a 24-hour period. The medication should not be used for more than 2 consecutive days in pediatric patients under 3 years of age without medical advice.

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, consultation is necessary if the child has not been adequately hydrated due to vomiting or diarrhea, or if there are pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Parents should also seek medical advice if the child is taking a diuretic, is under care for any serious condition, or is taking any other medications. It is crucial to keep this medication out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for geriatric patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits when prescribing this product to elderly patients, taking into account the lack of established safety and efficacy data in this population. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of geriatric patients.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the text does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider these factors when advising pregnant patients or women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there are no specific considerations or precautions related to lactation or breastfeeding mentioned in the provided text. Therefore, lactating mothers may use ibuprofen without special concerns related to 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, 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 identify any potential adverse effects related to liver function.

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.

It is essential for healthcare providers to weigh the benefits and risks of therapy in this patient population and to adjust treatment plans accordingly.

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 attention can significantly influence outcomes. 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.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Allergic reactions, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters, have been reported in the postmarketing experience. Serious adverse reactions such as headache, nausea, and vomiting may also occur. A warning regarding stomach bleeding is applicable to children with a history of stomach problems, such as heartburn, or those who have experienced serious side effects from pain relievers or fever reducers. Additionally, symptoms indicative of heart problems or stroke have been reported, including chest pain, difficulty breathing, weakness in one part or side of the body, slurred speech, and leg swelling. Reports of severe allergic reactions, including anaphylaxis, have been noted in the postmarketing experience.

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 child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, healthcare providers should inform patients to stop use and seek medical attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

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

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

Finally, healthcare providers should encourage patients to consult a doctor or pharmacist before use if the child is currently under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). Care must be taken to ensure that the product is not frozen, as freezing may compromise its integrity. Additionally, the product must not be used if the printed neckband is broken or missing, as this indicates potential tampering or compromise of the product's safety. Proper handling and storage conditions are essential to maintain the quality and efficacy of the product.

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.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and the necessity of seeking immediate medical assistance or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients are instructed to use only the enclosed dosing cup for administration and to wash it after each use to ensure proper hygiene.

Drug Information (PDF)

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