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Care One Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film Coated
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 3, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film Coated
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 3, 2025
Manufacturer
American Sales Company
Registration number
ANDA072096
NDC root
41520-604
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (8 NDCs)
Packaging & NDC Codes (8)

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Drug Overview

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that comes in 200mg tablets. It is commonly used to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. Additionally, ibuprofen can help reduce fever and alleviate discomfort associated with the common cold.

This medication works by blocking certain substances in the body that cause inflammation and pain, making it effective for various everyday ailments. If you're looking for a way to manage mild pain or fever, ibuprofen may be a suitable option for you.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it can help reduce fever for a short period.

It's important to note that there are no teratogenic effects (which means it does not cause birth defects) associated with this medication, ensuring it is safe in that regard.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed while you have symptoms. If you find that 1 tablet isn’t enough to relieve your pain or fever, you may take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises you otherwise.

For children under 12 years old, it’s best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after heart surgery, as it may pose risks in these situations. Always consult with your healthcare provider if you have any concerns or questions about your health and medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers or bleeding, or who consume alcohol regularly. The risk of heart attack and stroke is also increased with ibuprofen use, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain or weakness on one side of the body. It's important to talk to your doctor before using ibuprofen if you have a history of serious side effects from pain relievers, high blood pressure, heart disease, or other significant health issues.

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 are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use 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.

You should seek medical attention if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Also, contact your doctor if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or swelling in your legs. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, stop using ibuprofen and consult your doctor. In case of an overdose, get emergency medical help or contact a Poison Control Center at 1-800-222-1222.

Overdose

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

Do not wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs of overdose to ensure your safety and the safety of those around you.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using ibuprofen. This medication can pose risks to your unborn child and may lead to complications during delivery.

Particularly, you should avoid using ibuprofen after 20 weeks of pregnancy unless your doctor specifically advises you to do so. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you can give 2 tablets, but be careful not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always follow these guidelines to ensure safe and effective use.

Geriatric Use

As you age, it's important to be aware of certain risks associated with medications, especially nonsteroidal anti-inflammatory drugs (NSAIDs), which include many common pain relievers. If you are 60 years or older, you have a higher chance of experiencing severe stomach bleeding when taking these medications. Additionally, using NSAIDs (except for aspirin) can increase your risk of heart attack, heart failure, and stroke, particularly if you take more than the recommended dose or use them for an extended period.

To stay safe, always follow your healthcare provider's instructions regarding dosage and duration of use. If you have any concerns or experience unusual symptoms while taking these medications, be sure to discuss them with your doctor. Your health and well-being are the top priority, and understanding these risks can help you make informed decisions about your pain management.

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 (severe liver damage), asthma, or have experienced a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition closely to ensure your safety.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan. Your well-being is the priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking blood thinners (medications that prevent blood clots) or steroids. You should also check with them if you are using other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin, ibuprofen, or naproxen, as these can interact with each other. If you take aspirin for heart protection, be aware that ibuprofen may reduce its effectiveness.

Additionally, if you notice any signs of stomach bleeding—such as feeling faint, vomiting blood, having black or bloody stools, or persistent stomach pain—you should stop using the medication and consult your doctor. Similarly, if you experience symptoms of heart problems or a stroke, like chest pain, difficulty breathing, weakness on one side of your body, slurred speech, or swelling in your legs, seek medical attention immediately. Always prioritize discussing your medications and any potential interactions with your healthcare provider to ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep it away from high humidity and avoid exposing it to excessive heat, which can be anything above 40°C (104°F).

Before using the product, check the end panel for the lot number and expiration date to confirm its safety and effectiveness. Proper storage and handling will help maintain the quality of the product, so please follow these guidelines closely.

Additional Information

You should take this medication orally, with the recommended dose being 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve your pain or fever, you may take 2 tablets. However, do not exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication, especially after 20 weeks of pregnancy, as it may pose risks to your unborn child or lead to complications during delivery. Always keep this medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is ibuprofen used for?

Ibuprofen is used to temporarily relieve minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

What is the recommended dosage for adults and children 12 years and older?

You should take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, you may take 2 tablets, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

Can children under 12 years take ibuprofen?

Consult a doctor before giving ibuprofen to children under 12 years.

What should I do if I experience signs of stomach bleeding?

Stop use and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not get better.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if you have a history of stomach problems or are taking other medications.

Is ibuprofen safe to use during pregnancy?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

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 ibuprofen be stored?

Store ibuprofen between 20-25°C (68-77°F) and avoid high humidity and excessive heat above 40°C (104°F).

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

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) available in tablet form, each containing 200 mg of the active ingredient. It is indicated for the relief of pain and reduction of fever. The formulation is gluten-free and is supplied in a package containing 50 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened with the use of higher than recommended doses or prolonged use.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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 significant risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in higher doses or for extended periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any 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, patients should seek medical advice if their pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a healthcare provider if they have experienced serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use. Additionally, patients taking diuretics or aspirin for heart attack or stroke should consult a doctor or pharmacist, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking anticoagulants or steroid medications. The potential for increased bleeding risk necessitates careful consideration and monitoring.

Additionally, individuals using other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, should seek advice from a healthcare provider. The concomitant use of these medications may elevate the risk of adverse effects.

Particular caution is advised for patients taking aspirin for cardiovascular protection. The co-administration of ibuprofen may diminish the cardioprotective effects of aspirin, which warrants a discussion with a healthcare professional.

Patients are advised to discontinue use and seek medical attention if they experience any signs indicative of gastrointestinal bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or persistent stomach pain.

Furthermore, individuals should stop using the medication and consult a healthcare provider if they exhibit symptoms suggestive of cardiovascular events or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Monitoring for these symptoms is essential to ensure patient safety.

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 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal complications.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further heightened in elderly patients who exceed the recommended dosage or duration of treatment. Therefore, careful consideration of dosage adjustments and ongoing assessment of the patient's cardiovascular status is advised when prescribing NSAIDs to geriatric patients.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, especially if they are in the later stages of pregnancy or breastfeeding. It is particularly important to avoid the use of ibuprofen after 20 weeks of gestation unless explicitly directed by a physician. The use of ibuprofen during pregnancy may pose risks to the unborn child and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for women of childbearing potential when contemplating the use of this medication.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication 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, liver cirrhosis, asthma, 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 should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in patients with hepatic impairment to ensure appropriate management and to mitigate potential risks associated with the use of this medication.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

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 essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). For tracking purposes, the lot number and expiration date can be found on the end panel of the packaging.

Additional Clinical Information

Patients should take the medication orally, with a recommended dosage of 1 tablet every 4 to 6 hours as needed for symptom relief. If symptoms do not improve with 1 tablet, 2 tablets may be taken. However, the total daily dosage should not exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen after 20 weeks of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

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.