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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
May 22, 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
May 22, 2025
Manufacturer
American Sales Company
Registration number
ANDA074937
NDC root
41520-897
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

CAREone® is an oral suspension that contains ibuprofen, a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed for children aged 2 to 11 years and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, CAREone® helps reduce fever, providing comfort when your child is feeling unwell.

This medication comes in a berry flavor and is alcohol-free and gluten-free, making it a suitable option for many children. Each 4 FL OZ (118mL) bottle contains a dosage cup for easy measurement, ensuring you can give the correct amount to your child.

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 provided, which is based on weight. If you can't use weight, you can use age as a guide.

When measuring the dose, use only the enclosed dosing cup, as other devices may not provide accurate measurements. For children, if the dose is needed again, you can repeat it every 6 to 8 hours, but do not use it more than four times in a single 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), it's best to consult a doctor before giving this medication.

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 discuss any concerns with a healthcare professional before using ibuprofen, especially if your child has existing health issues 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

If you are pregnant or planning to become pregnant, it's important to be cautious with medications like ibuprofen. The use of ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby, including potential cardiovascular issues and other complications. Additionally, taking nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy has been linked to an increased risk of miscarriage and other negative outcomes.

Before considering any medication, including ibuprofen, you should consult your healthcare provider. They can help determine if any dosage adjustments are necessary and guide you on safe options for managing pain or inflammation during your pregnancy. Always prioritize your health and your baby's well-being by seeking professional advice.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it’s important to consult your doctor first. This is because ibuprofen can potentially be passed into your breast milk, which may pose risks to your nursing infant. Therefore, exercising caution is advised when taking this medication while breastfeeding. Always prioritize your health and your baby's safety by discussing any medications with your healthcare provider.

Pediatric Use

It's important to be cautious when giving medication to children. For children under 3 years old, you should only use this medication if directed by a doctor. If your child is between 2 and 3 years old and weighs between 24-35 pounds, the recommended dose is 5 mL. For older children, the dosage increases based on their weight and age, so be sure to follow the dosing chart or consult your doctor for guidance.

You should not use this medication for more than 2 days without a doctor's advice. Always keep it out of reach of children, and in case of an overdose, seek medical help immediately. If your child has a history of allergies to pain relievers or is taking other medications, consult a doctor or pharmacist before use. Additionally, if your child experiences any unusual symptoms, such as stomach pain, vomiting blood, or if their condition worsens, stop use and contact a healthcare professional.

Geriatric Use

When considering the use of this medication, it's important to note that its safety and effectiveness for older adults have not been fully established. If you are caring for an elderly person, be aware that they may have reduced kidney function, which can affect how the body processes ibuprofen. This means that the medication may stay in their system longer, potentially increasing the risk of side effects.

Older adults can also be more sensitive to the side effects of nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, which can include serious issues such as gastrointestinal bleeding and heart problems. Because of these factors, dosage adjustments may be necessary to ensure safety. Always consult with a healthcare provider to determine the appropriate dosage and monitor for any adverse 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.

Hepatic Impairment

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

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 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 necessary, you can repeat the dose every 6 to 8 hours, but do not exceed 4 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, a pain reliever and fever reducer, suitable for children aged 2 to 11 years.

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 the recommended doses.

What are the side effects of CAREone®?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Consult a doctor if any serious symptoms occur.

Can I give CAREone® to my child if they have allergies?

Do not use CAREone® if your child has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is CAREone® safe during pregnancy?

The use of ibuprofen during pregnancy is contraindicated, especially in the third trimester, due to potential risks to the fetus.

What should I do if my child experiences stomach bleeding?

Stop using CAREone® and seek medical help if your child shows signs of stomach bleeding, such as faintness, vomiting blood, or black stools.

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.

Can I give CAREone® with food?

Yes, it is recommended to give CAREone® with food or milk if your child experiences stomach upset.

What if my child does not get relief from CAREone®?

If your child does not experience relief within the first 24 hours, or if symptoms worsen, consult a doctor.

What is the maximum dosage for CAREone®?

Do not use CAREone® more than 4 times a day, and doses should be repeated every 6-8 hours as needed.

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 use in children aged 2 to 11 years. Each 5 mL dose delivers 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The product is alcohol-free and gluten-free, and it features a berry flavor for palatability. The suspension is packaged in a 4 FL OZ (118 mL) bottle, and a dosage cup is included for accurate measurement. The effects of the medication 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 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 recommended dose is 15 mL.

The product should be shaken well before use. It is crucial to utilize only the enclosed dosing cup for administration; other dosing devices are not recommended. Doses may be repeated every 6-8 hours as needed, but should not exceed four 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. 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those concurrently using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

NSAIDs, with the exception of aspirin, are associated with an elevated 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 an extended period.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the medication is to be administered to children under three years of age without a doctor's directive.

It is crucial to advise caregivers to discontinue use and consult a physician if the child exhibits any of the following signs of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing stomach pain that does not improve. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. 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, a healthcare provider should be consulted. Any new symptoms that arise should also prompt a discussion with a physician.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

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 potential severe stomach bleeding. The risk of this serious adverse effect 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, exceeding the recommended dosage or duration of use increases the likelihood of stomach bleeding.

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, and the risk is amplified when the medication is used in excess of the recommended guidelines.

In clinical observations, severe or persistent sore throat, particularly 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 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 advisable for patients to consult a doctor if any of the following apply: a history of stomach problems, 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. Patients with asthma or those taking diuretics should also seek medical advice prior to use. Additionally, individuals under a doctor's care for any serious condition or those taking other medications should consult a healthcare professional 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 compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including 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. Consultation with a physician is recommended if the patient is on any additional 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 11 years, dosing is based on weight and age, as follows:

  • 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 may also be directed by a physician. The medication should not be used for more than 2 days in children under 3 years of age without medical advice. It is important to keep the medication out of reach of children.

Healthcare professionals should advise parents to seek medical help or contact a Poison Control Center immediately in the event of an overdose. Prior to administration, it is recommended to consult a doctor if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, is under a doctor's care for any serious condition, or is taking other medications.

To minimize gastrointestinal discomfort, the medication can be given with food or milk. Parents should be instructed to stop use and consult a doctor if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if the child does not experience relief within the first 24 hours, if fever or pain worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms appear, medical advice should be sought.

Geriatric Use

Elderly patients may exhibit altered pharmacokinetics, necessitating careful consideration when prescribing this product. The safety and efficacy of ibuprofen in geriatric patients have not been established, which underscores the importance of cautious use in this population.

It is important to note that geriatric patients may have reduced kidney function, potentially affecting the clearance of ibuprofen. Consequently, dosage adjustments may be necessary to mitigate the risk of adverse effects. Additionally, elderly patients may be more sensitive to the side effects associated with nonsteroidal anti-inflammatory drugs (NSAIDs), including gastrointestinal bleeding and cardiovascular events.

Healthcare providers should closely monitor geriatric patients for these risks and consider individual patient factors when determining the appropriate dosage and treatment regimen.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. Ibuprofen may pose risks to the fetus, including potential cardiovascular effects and other complications. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, during pregnancy has been associated with an increased risk of miscarriage and other adverse outcomes.

Dosage modifications may be necessary, and it is advised that pregnant patients consult a healthcare provider before using ibuprofen. Special precautions should be taken, and pregnant women should avoid using ibuprofen unless specifically directed by a healthcare professional.

Lactation

Lactating mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. Caution is advised when administering ibuprofen to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

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

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

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects effectively.

Overdosage

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

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and 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 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 the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of ongoing safety monitoring.

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 discuss the child's fluid intake; patients should be advised to seek medical advice if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea.

Healthcare providers should also inquire about the child's medical history, specifically if there are any existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. It is crucial to ask about asthma and the use of diuretics, as these factors may influence the safety of the medication.

Furthermore, patients should be encouraged to consult a doctor or pharmacist if the child is under care for any serious condition or is taking any other medications, to ensure safe and effective use of the medication.

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.

Healthcare professionals should also ensure that the product is not utilized if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and storage conditions are crucial for ensuring the product remains safe and effective for patient use.

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

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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.