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Physicians Care Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2016
Label revision date
October 31, 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, 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 2016
Label revision date
October 31, 2025
Manufacturer
Acme United Corporation
Registration number
ANDA075010
NDC root
0924-0075
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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Drug Overview

Ibuprofen is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. It is commonly used to temporarily relieve minor aches and pains associated with various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain. Additionally, ibuprofen can help reduce fever, making it a versatile option for managing discomfort and illness.

This medication is available in coated tablet form, typically packaged in tamper-evident packets for safety. Each tablet contains 200 mg of ibuprofen, and it is important to use it as directed to ensure effectiveness and safety.

Uses

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

This medication is designed to provide you with quick relief from discomfort, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

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 otherwise.

For children under 12 years of age, this medication is not recommended, so please do not give it to them. Remember to take the tablets by mouth, and only use them as directed to ensure your safety and effectiveness of the treatment.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to 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 eligibility to use this medication.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, and blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

Additionally, ibuprofen carries risks of stomach bleeding, particularly for individuals over 60, those with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for extended periods. Be alert for signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, as well as symptoms of heart problems or stroke, like chest pain or weakness on one side of the body. If you notice any concerning symptoms, contact your doctor right away.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this medication. First, if you have a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, or blisters. If you experience any of these symptoms, stop using the medication and seek emergency medical help immediately.

This medication can also increase the risk of serious stomach bleeding, especially 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 it for longer than directed. Additionally, using NSAIDs (nonsteroidal anti-inflammatory drugs) like ibuprofen can raise the risk of heart attack and stroke, particularly if taken in higher doses or for extended periods.

You should stop using this medication and contact your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black or bloody stools. Also, seek medical advice if you experience chest pain, trouble breathing, leg swelling, weakness on one side of your body, slurred speech, or if your pain or fever worsens or lasts longer than expected. Always consult your doctor if you notice any new or unexpected symptoms.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always seek guidance from your doctor to ensure the safety of both you and your baby.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time without a doctor's guidance may lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking professional advice.

Pediatric Use

It's important to be cautious when giving medication to children. You should not give this medication to children under 12 years of age. For those who are 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets, but be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always consult with a healthcare professional if you have any questions or concerns about medication for your child.

Geriatric Use

As you age, it's important to be aware of certain risks associated with medications, especially those containing NSAIDs (nonsteroidal anti-inflammatory drugs). If you are 60 years or older, the chance of experiencing severe stomach bleeding increases. This is a serious concern, so it's crucial to follow the dosage instructions carefully and not exceed the recommended amount.

Additionally, using these medications for longer than directed can raise your risk of heart attack or stroke, particularly in older adults. Always consult with your healthcare provider to ensure that you are using these medications safely and effectively, keeping your health and well-being in mind.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and ensure the best possible care for your health.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25ºC (68-77°F). It's important to keep it away from excessive heat, so avoid temperatures above 40°C (104°F). When handling the product, make sure to only use packets that are unopened and intact; do not use any that are opened or torn, as this could compromise the product's safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure it works as intended.

Additional Information

No further information is available.

FAQ

What is Ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that temporarily relieves minor aches and pains associated with headaches, toothaches, backaches, menstrual cramps, common colds, muscular aches, and minor arthritis pain.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and older should take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

Can children under 12 take Ibuprofen?

No, do not give Ibuprofen to children under 12 years of age.

What should I do if I experience an allergic reaction?

If you experience symptoms of a severe allergic reaction, such as hives, facial swelling, or difficulty breathing, stop using Ibuprofen and seek medical help immediately.

What are the warnings associated with Ibuprofen?

Ibuprofen may cause severe stomach bleeding, especially in older adults or those with certain medical conditions. It also increases the risk of heart attack and stroke, particularly if used more than directed.

Is it safe to use Ibuprofen during pregnancy?

If you are pregnant or breastfeeding, consult 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.

How should I store Ibuprofen?

Store Ibuprofen at 20-25ºC (68-77°F) and avoid excessive heat above 40°C (104°F). Do not use any opened or torn packets.

What should I do if I have stomach bleeding symptoms?

Stop using Ibuprofen and ask a doctor if you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools.

Packaging Info

Below are the non-prescription pack sizes of Physicians Care Ibuprofen (ibuprofen 200mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Physicians Care Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, common cold, muscular aches, and minor arthritis pain. 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 orally 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, the medication is contraindicated and should not be administered.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any 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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, 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 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.

Furthermore, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment.

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should seek medical attention if they exhibit symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, leg swelling, weakness on one side of the body, or slurred speech. Patients should also be instructed to contact their healthcare provider 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 or unexpected symptoms arise.

In cases of an allergic reaction, it is crucial to stop the medication and obtain emergency medical help immediately.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, and blisters. In the event of an allergic reaction, patients should discontinue use immediately and seek medical assistance.

The use of this NSAID is also associated with an increased risk of severe stomach bleeding, particularly 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. Signs of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should seek medical advice if any of these symptoms occur.

Additionally, the use of NSAIDs, excluding aspirin, has been linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should be vigilant for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, leg swelling, weakness on one side of the body, or slurred speech, and should seek medical attention if these occur.

Common adverse reactions may include worsening pain that lasts longer than 10 days, fever that worsens or persists beyond three days, redness or swelling in the affected area, or any new or unexpected symptoms.

Patients are advised to consult a healthcare professional prior to use if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended that patients taking aspirin for heart attack or stroke consult a doctor, as ibuprofen may diminish the cardioprotective effects of aspirin.

In summary, while ibuprofen can be effective for pain relief, it is essential for patients to be aware of the potential serious adverse reactions and to seek medical advice when necessary.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Physicians Care Ibuprofen (ibuprofen 200mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Physicians Care Ibuprofen.
Details

Pediatric Use

Children under 12 years of age should not be administered this medication. For pediatric patients 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 taken. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, as the likelihood of gastrointestinal complications may be heightened in this population.

Additionally, the risk of cardiovascular events, such as heart attack or stroke, is elevated in elderly patients who exceed the recommended dosage or duration of use. Therefore, it is crucial to adhere strictly to the prescribed guidelines and monitor these patients closely for any signs of adverse effects.

Healthcare providers should consider these factors when evaluating treatment options for geriatric patients and may need to implement dose adjustments or enhanced monitoring protocols to ensure patient safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the benefits and risks when considering the use of this medication in pregnant patients, especially in the later stages of pregnancy.

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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports include gastrointestinal bleeding, renal impairment, and cardiovascular events. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of liver enzyme elevations and liver failure have been reported.

Anaphylactic reactions have been noted in patients taking ibuprofen, and there have been instances of asthma exacerbation in individuals with a history of asthma. Furthermore, postmarketing data indicate an increased risk of heart attack and stroke, particularly in patients with pre-existing cardiovascular conditions.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is important to inform patients that they should not use this medication right before or after heart surgery.

Healthcare providers should instruct patients to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be advised to seek medical attention if they exhibit symptoms of heart problems or stroke, such as chest pain, difficulty breathing, leg swelling, weakness on one side of the body, or slurred speech.

Patients should be informed to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. They should also be advised to seek medical advice if there is redness or swelling in the painful area, or if any new or unexpected symptoms arise.

When using this product, patients should be encouraged to take it with food or milk if they experience stomach upset. Healthcare providers should recommend that patients consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Patients should also be advised to seek medical advice if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems such as heartburn. Furthermore, it is essential to inform patients to consult a doctor before use if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Patients taking a diuretic should also be advised to consult a doctor before using this medication. Additionally, healthcare providers should recommend that patients speak with a doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are under medical care for any serious condition or if they are taking any other medications.

Storage and Handling

The product is supplied in packages that must be stored at a temperature range of 20-25ºC (68-77°F). It is essential to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Healthcare professionals should ensure that opened or torn packets are not utilized, as this may compromise the integrity of the product. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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