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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)
Marketed in the U.S.
Since 2020
Label revision date
January 3, 2022
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
Marketed in the U.S.
Since 2020
Label revision date
January 3, 2022
Manufacturer
RITE AID
Registration number
ANDA091237
NDC root
11822-7893

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Drug Overview

Ibuprofen is a medication that temporarily relieves minor aches and pains caused by various conditions, such as backaches, headaches, menstrual cramps, arthritis, muscular aches, the common cold, and toothaches. In addition to alleviating pain, ibuprofen also helps to reduce fever, making it a versatile option for managing discomfort and illness.

Uses

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

This medication is designed to provide you with quick relief from these everyday discomforts, making it easier for you to go about your daily activities. Always remember to follow the recommended guidelines for use.

Dosage and Administration

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

For children under 12 years of age, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

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 serious 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 side effects, including severe allergic reactions, particularly in individuals allergic to aspirin. Symptoms of an allergic reaction may include wheezing, blisters, facial swelling, hives, rash, shock, and skin reddening. Additionally, this medication can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking blood thinners or other NSAIDs. 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 a heart problem or stroke, like chest pain, difficulty breathing, 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 stomach issues, high blood pressure, heart disease, or if you are taking other medications.

Warnings and Precautions

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

Ibuprofen 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-thinning medications, consume three or more alcoholic drinks daily, or use it for longer than recommended. Additionally, using ibuprofen may raise your risk of heart attack and stroke, particularly if taken in higher doses or for extended periods.

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

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 during the last three months of pregnancy, as using ibuprofen during this time can lead to potential 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.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication, including ibuprofen. During the last three months of pregnancy, you should avoid ibuprofen unless your doctor specifically advises you to take it, as it may pose risks to your unborn child or lead to complications during delivery. Always prioritize your health and the health of your baby by seeking professional guidance.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is one caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may give two caplets, but be careful not to exceed six caplets in a 24-hour period unless a doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware of certain precautions when taking medications like ibuprofen. If you are 60 or older, you have a higher risk of experiencing severe stomach bleeding. To help prevent stomach upset, consider taking ibuprofen with food or milk.

When using ibuprofen, it's best to use the smallest effective dose, especially for older adults. Be cautious not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. Always consult with your healthcare provider if you have any concerns or questions about your medication.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications and substances. For instance, if you take ibuprofen along with aspirin for heart health, it may reduce the effectiveness of aspirin. Additionally, if you are on blood thinners (medications that prevent blood clots) or steroids, using ibuprofen can increase your risk of stomach bleeding. This risk is even higher if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, or if you consume three or more alcoholic drinks daily.

Always discuss any medications you are taking, including over-the-counter drugs like ibuprofen, with your healthcare provider. They can help you understand the potential risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25ºC (68-77ºF). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is ibuprofen used for?

Ibuprofen is used to temporarily relieve minor aches and pains from conditions like backache, headache, menstrual cramps, arthritis, muscular aches, the common cold, and toothache, as well as to reduce fever.

How should adults and children 12 years and over take ibuprofen?

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

What should I do if I experience stomach bleeding while taking ibuprofen?

If you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop use and ask a doctor immediately.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increases the risk of heart attack and stroke. It's important to follow dosing instructions carefully.

Can I take ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using ibuprofen, especially during the last 3 months of pregnancy.

What should I do if I have a history of allergic reactions to pain relievers?

Do not use ibuprofen if you have ever had an allergic reaction to it or any other pain reliever/fever reducer.

How should ibuprofen be taken to avoid stomach upset?

It is recommended to take ibuprofen with food or milk if stomach upset occurs.

What should I do if my pain or fever lasts more than the recommended duration?

If your pain worsens or lasts more than 10 days, or if your fever lasts more than 3 days, stop use and consult a doctor.

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SPL Code 34089-3 corresponds to Ibuprofen 200 mg caplets, which are presented in an orange color. The product is available in two packaging formats: bottles and cartons. The bottle packaging is offered in quantities of 50 and 100 caplets, while the carton packaging is also available in quantities of 50 and 100 caplets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, headache, menstrual cramps, minor pain of arthritis, muscular aches, the common cold, and toothache. 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 over are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets 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 is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

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

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

  • Are aged 60 years or older

  • Have a history of stomach ulcers or bleeding disorders

  • Are concurrently using anticoagulants or steroid medications

  • Are taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

  • Consume three or more alcoholic beverages daily while using this product

  • Exceed the recommended dosage or duration of use

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who exceed the recommended dosage or duration of treatment.

Monitoring and Consultation Healthcare professionals should advise patients to discontinue ibuprofen and consult a physician if they experience any of the following symptoms, which may indicate stomach bleeding:

  • Feeling faint

  • Vomiting blood

  • Presence of bloody or black stools

  • Persistent stomach pain that does not improve

Additionally, patients should seek medical advice if they exhibit symptoms suggestive of heart problems or stroke, including:

  • Chest pain

  • Difficulty breathing

  • Weakness localized to one side of the body

  • Slurred speech

  • Swelling in the legs

Patients should also be instructed to consult a 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 symptoms arise.

Emergency Medical Help In the event of an overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

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 asthma (wheezing), blisters, facial swelling, hives, rash, shock, and skin reddening.

The use of this NSAID is also associated with an increased 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 while using this product, or exceed the recommended dosage or duration of use.

Additionally, there is a significant 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 dosage or for prolonged periods.

Patients should 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, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise, patients should seek medical advice.

Before using this product, patients should consult a healthcare provider 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 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. It is important for patients taking aspirin for heart attack or stroke to consult a doctor, as ibuprofen may diminish the cardioprotective effects of aspirin. Additionally, patients under a physician's care for any serious condition or those taking other medications should discuss their use of ibuprofen with a healthcare professional.

Drug Interactions

Ibuprofen may interact with several classes of drugs, leading to significant clinical effects, particularly concerning gastrointestinal safety and cardiovascular efficacy.

Pharmacodynamic Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when both medications are used concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin for these indications to ensure optimal therapeutic outcomes.

The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider alternative analgesics or implement stringent monitoring protocols for patients requiring both ibuprofen and these agents.

Pharmacokinetic Interactions

The risk of gastrointestinal bleeding is further exacerbated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. It is recommended that healthcare providers assess the necessity of multiple NSAID therapies and consider dose adjustments or alternative pain management strategies.

Additionally, the consumption of alcohol, particularly in amounts of three or more drinks daily, while using ibuprofen increases the likelihood of stomach bleeding. Patients should be counseled on the risks associated with alcohol use during ibuprofen therapy and advised to limit or avoid alcohol consumption to mitigate this risk.

Packaging & NDC

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

Packaging configurations for 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 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. Due to this heightened risk, it is advisable for geriatric patients to take ibuprofen with food or milk to mitigate potential stomach upset.

When prescribing ibuprofen to older adults, healthcare providers should utilize the smallest effective dose to achieve the desired therapeutic effect. Additionally, it is crucial not to exceed 6 caplets within a 24-hour period unless specifically directed by a physician, with particular caution exercised for elderly patients. Regular monitoring and assessment of the patient's response to treatment are recommended to ensure safety and efficacy.

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 during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare provider, 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 in lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No additional non-teratogenic effects or specific nonclinical toxicology details have been identified in the available data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including cases of anaphylaxis, angioedema, and various skin reactions such as rash, pruritus, and urticaria. Gastrointestinal adverse events have also been reported, encompassing gastrointestinal bleeding, ulceration, and perforation.

Cardiovascular events, including myocardial infarction and stroke, have been documented. Additionally, renal adverse events such as acute renal failure and interstitial nephritis have been observed. Hepatic adverse events, including elevations in liver enzymes and instances of hepatitis, have been reported as well.

Hematologic adverse reactions, including thrombocytopenia and aplastic anemia, have been noted. Central nervous system effects, such as headache, dizziness, and drowsiness, have also been documented. Other adverse reactions reported include tinnitus and visual disturbances.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients must be informed not to use this medication if they have ever experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Patients should be instructed 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. They should also seek medical advice if they exhibit symptoms of a heart problem or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

It is important to inform patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Patients should be advised to take the medication with food or milk if they experience stomach upset. They should also be encouraged to consult a doctor before use if they have a history of problems or serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning applies to them.

Furthermore, patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice before using this medication. Those taking diuretics or aspirin for heart attack or stroke should also consult a doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should discuss their use of this product with a healthcare professional.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25ºC (68-77ºF) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range at all times.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.

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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.