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Ibuprofen Pain Reliever/Fever Reducer

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
October 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Capsule, Liquid Filled
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 2011
Label revision date
October 25, 2024
Manufacturer
Amneal Pharmaceuticals LLC
Registration number
ANDA202300
NDC root
65162-770
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains caused by various conditions, such as headaches, toothaches, backaches, menstrual cramps, muscular aches, and even minor arthritis pain. Additionally, it can help reduce fever, making it a versatile option for managing discomfort associated with common ailments like the cold.

By targeting the sources of pain and discomfort, this medication provides you with relief when you need it most, allowing you to feel more comfortable in your daily activities.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even minor arthritis pain. It can also help ease discomfort associated with the common cold.

In addition to pain relief, this medication is effective in temporarily reducing fever. It's important to remember that while it can help with these symptoms, it does not address the underlying causes of your discomfort.

Dosage and Administration

When you need relief from pain or fever, adults and children aged 12 years and older can take 1 capsule every 4 to 6 hours as long as symptoms continue. If you find that 1 capsule isn’t enough to ease your discomfort, you can take 2 capsules instead. However, it’s important not to exceed 6 capsules in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it’s best to consult a doctor before giving them this medication. This ensures that they receive the appropriate care and dosage for their age and condition. Always follow these guidelines to use the medication safely and effectively.

What to Avoid

It's important to be cautious when considering this medication. You should not use it if you have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it may pose serious risks in these situations.

If you have a history of allergies to pain relievers or fever reducers, or if you are scheduled for heart surgery, please consult your healthcare provider for alternative options. Your safety is paramount, so make sure to discuss any concerns with a medical professional.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

If you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, you should stop using ibuprofen and consult a doctor. It's important to talk to your healthcare provider before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if you are 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 immediately and seek medical help.

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. Before using ibuprofen, consult your doctor if you have any stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if you are taking diuretics or other medications.

If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, stop taking ibuprofen and contact your doctor. Additionally, if your fever worsens or lasts more than three days, or if you develop new symptoms, seek medical advice.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, stomach pain, drowsiness (extreme tiredness), headache, and confusion.

If you suspect an overdose, seek immediate medical help or contact a Poison Control Center right away. Acting quickly can make a significant difference in ensuring safety and receiving the appropriate care.

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 can potentially cause issues for 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 you have a child 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 1 capsule every 4 to 6 hours as needed for symptoms. If one capsule does not relieve pain or fever, you may give 2 capsules, but be careful not to exceed 6 capsules in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, extra caution is needed when taking certain medications, especially those that can irritate the stomach.

Always consult with your healthcare provider about the safest options for you, and make sure to discuss any medications you are currently taking. Being proactive about your health can help minimize risks and ensure you receive the best care possible.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 be aware of how certain medications can interact with each other. For instance, if you take aspirin to prevent heart attacks or strokes, using it alongside ibuprofen may reduce the effectiveness of aspirin. Additionally, ibuprofen can increase the risk of severe stomach bleeding, particularly if you are also taking blood thinners (medications that prevent blood clots) or steroids.

Moreover, using ibuprofen for longer than recommended can raise your chances of experiencing a heart attack or stroke. Always discuss any medications you are taking, including over-the-counter drugs like ibuprofen, with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20º to 25ºC (68º to 77ºF). It's important to avoid exposing it to excessive heat, particularly temperatures above 40ºC (104ºF), as this can affect its effectiveness. Always keep the carton for storage, as it helps protect the product.

When handling the product, check that the printed foil under the cap is intact. If it is broken or missing, do not use the product, as this could indicate that it has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Specifically, avoid using ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis.

How does this drug help with fever?

It temporarily reduces fever.

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

You should take 1 capsule every 4 to 6 hours while symptoms persist, and you can use 2 capsules if pain or fever does not respond to 1 capsule. Do not exceed 6 capsules in 24 hours unless directed by a doctor.

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 contraindications for using this drug?

Do not use this drug if you have ever had an allergic reaction to any other pain reliever or fever reducer, or right before or after heart surgery.

What precautions should I take if I am pregnant or breastfeeding?

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

What should I do if I have a history of stomach problems?

Ask a doctor before use if you have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to you.

What are the allergy alerts associated with this drug?

This drug may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives, facial swelling, and asthma (wheezing).

What storage conditions are recommended for this drug?

Store at 20º to 25ºC (68º to 77ºF) and avoid excessive heat above 40ºC (104ºF).

Packaging Info

Below are the non-prescription pack sizes of Ibuprofen Pain Reliever/Fever Reducer (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen Pain Reliever/Fever Reducer.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis. 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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, a dosage of 2 capsules may be administered. It is imperative that the total daily dosage does not exceed 6 capsules 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 prior to administration.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks related to surgical recovery and cardiovascular stability.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using 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.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, existing gastrointestinal issues such as heartburn, or comorbidities including high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics should seek medical advice before use.

Patients under medical supervision for serious conditions or those taking aspirin for cardiovascular protection should also consult a healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin. It is advisable for patients to discuss any concurrent medications with their doctor or pharmacist.

In the event of symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days, patients should discontinue use and contact their healthcare provider. Furthermore, if fever persists or worsens beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise, medical consultation is warranted.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the 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 the product, or exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain that worsens. Other concerning symptoms include fever that worsens or lasts more than three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended to consult a healthcare provider if the stomach bleeding warning applies or if the patient is under treatment for any serious condition, is taking aspirin for cardiovascular protection, or is using any other medications.

Drug Interactions

The concomitant use of ibuprofen with aspirin, particularly in the context of cardiovascular protection, may diminish the therapeutic efficacy of aspirin. This interaction is significant for patients who are using aspirin for the prevention of heart attacks or strokes.

When ibuprofen is administered alongside anticoagulants or steroid medications, there is an increased risk of severe gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of gastrointestinal complications when these medications are co-prescribed.

Additionally, prolonged use of ibuprofen beyond the recommended dosage may elevate the risk of cardiovascular events, including heart attack and stroke. It is advisable for healthcare providers to assess the necessity of ibuprofen therapy and to ensure that patients adhere to the prescribed duration and dosage to mitigate these risks.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen Pain Reliever/Fever Reducer (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen Pain Reliever/Fever Reducer.
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 capsule every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for gastrointestinal symptoms and bleeding is advised in geriatric patients, especially when initiating or adjusting dosages of medications known to affect gastric mucosa. Dose modifications may be necessary based on individual patient assessments and the presence of comorbidities that could further elevate the risk of adverse effects.

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 prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 outlined 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

Overdosage of ibuprofen can lead to significant health risks and serious harm. Healthcare professionals should be aware of the potential symptoms and recommended actions in the event of an overdose.

Symptoms of Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. These symptoms can vary in severity and may require prompt medical evaluation.

Recommended Actions In the event of an overdose, it is crucial to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance. Timely intervention is essential to mitigate the potential adverse effects associated with ibuprofen overdosage.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, severe stomach bleeding has been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking anticoagulants or steroid medications, individuals consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage.

Furthermore, reports of cardiovascular events, including heart attack and stroke, have been associated with the use of ibuprofen, especially when utilized in higher doses or for extended periods.

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 immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Healthcare providers should counsel 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, experiencing persistent stomach pain, or if pain worsens or lasts more than 10 days. Patients should also be advised to seek medical attention if fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms appear.

When using this product, patients should be encouraged to take it with food or milk if they experience an upset stomach. It is important to inform patients that the risk of heart attack or stroke may increase if they use more than the recommended dose or for a longer duration than directed.

Patients should be advised to consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have experienced problems or serious side effects from taking pain relievers or fever reducers in the past. Those with a history of stomach issues, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also seek medical advice prior to use.

Furthermore, patients taking a diuretic or under a doctor’s care for any serious condition should consult their healthcare provider or pharmacist before using this medication. It is also essential to inform patients that if they are taking aspirin for heart attack or stroke, they should discuss this with their doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients should be encouraged to consult their healthcare provider or pharmacist if they are taking any other medications.

Storage and Handling

The product is supplied in a carton that should be retained for storage. It is essential to store the product at a temperature range of 20º to 25ºC (68º to 77ºF). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Additionally, the product should not be used if the printed foil under the cap is broken or missing, as this may indicate compromised integrity.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Ibuprofen Pain Reliever/Fever Reducer, 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 Pain Reliever/Fever Reducer, 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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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.