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Pain Reliever / Fever Reducer

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
May 17, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet
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 2021
Label revision date
May 17, 2021
Manufacturer
Pioneer Life Sciences, LLC
Registration number
part343
NDC root
72090-002
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Ibuprofen is a medication that temporarily relieves minor aches and pains caused by various conditions, such as headaches, toothaches, backaches, menstrual cramps, and muscular aches. It is also effective in alleviating minor pain associated with arthritis and can help reduce fever. This makes ibuprofen a versatile option for managing discomfort and promoting overall well-being.

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, helping you feel more comfortable when you're not feeling well.

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. For adults and children aged 12 years and older, you should take 1 tablet every 4 to 6 hours as needed while your symptoms last. If you find that 1 tablet isn't enough to relieve your pain or fever, you can take 2 tablets instead. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

If you are giving this medication to a child under 12 years old, it's best to consult with a doctor first to determine the appropriate dosage. Always remember to use the smallest effective dose to manage your symptoms safely.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, always use it responsibly and as directed. Your health and safety are paramount, so please follow these guidelines closely.

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. If you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools, you should stop using ibuprofen and consult a doctor immediately.

It's important to avoid ibuprofen if you have had allergic reactions to pain relievers or if you are about to undergo heart surgery. Before using this medication, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, or are taking other medications, especially aspirin for heart conditions, as ibuprofen may reduce its effectiveness. If you are pregnant or breastfeeding, seek advice from a healthcare professional before use, particularly in the last trimester of pregnancy. Always keep this medication out of reach of children and seek immediate medical help in case of overdose.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, particularly 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. Additionally, this medication can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or use other NSAIDs (nonsteroidal anti-inflammatory drugs).

Before using ibuprofen, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking diuretics or other medications. It’s also important to take ibuprofen with food or milk to help prevent stomach upset. If you notice signs of stomach bleeding (like fainting, vomiting blood, or black stools), or symptoms of heart problems or stroke (such as chest pain or trouble breathing), stop using the medication and contact your doctor right away.

If you are pregnant or breastfeeding, consult a healthcare professional before using ibuprofen, especially during the last three months of pregnancy. Keep this medication out of reach of children, and in case of overdose, seek medical assistance or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy and be aware of the signs that indicate you need urgent assistance. Your health is important, so don’t hesitate to reach out for help if you think you’ve taken too much of a medication.

Pregnancy 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 using ibuprofen unless your doctor specifically advises you to do so, as it can potentially harm your unborn child or lead to complications during delivery. 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 any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, as using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, you can administer 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you may give 2 tablets. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate dosage for your child.

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 should be taken when using 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 taking to help minimize potential risks. Your health and safety are paramount, so staying informed and proactive is key.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. This information helps ensure that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor regarding your health status and any medications you are considering.

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 more closely.

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 affect your treatment plan. Your safety is the priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to be aware that if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. This means that if you're relying on aspirin for heart health, you should discuss your use of ibuprofen with your healthcare provider to ensure you're getting the full benefit of your medications.

Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, can increase your risk of stomach bleeding. Always talk to your healthcare provider about all the medications you are taking, including over-the-counter drugs, to avoid potential interactions and 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 avoid exposing it to excessive heat, as temperatures above 40°C (104°F) can compromise its effectiveness.

When handling the product, always do so with clean hands and in a sterile field (a clean area free from germs) to maintain safety and prevent contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Ibuprofen used for?

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

What should I know about taking Ibuprofen?

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

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin, and it can increase the risk of stomach bleeding, particularly in older adults or those with certain medical conditions.

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

If you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools, stop using Ibuprofen and seek medical help immediately.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Ibuprofen. It is especially important not to use it during the last 3 months of pregnancy unless directed by a doctor.

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

If you have a history of stomach problems, such as ulcers or bleeding, or if you have high blood pressure, heart disease, or other serious conditions, ask a doctor before using Ibuprofen.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

How should I store Ibuprofen?

Store Ibuprofen at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).

Packaging Info

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

Packaging configurations for Pain Reliever / Fever Reducer.
Details

Drug Information (PDF)

This file contains official product information for Pain Reliever / Fever Reducer, 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) with the chemical formula C13H18O2. The molecular weight of ibuprofen is 206.28 g/mol. Specific physical characteristics and inactive ingredients are not provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including 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

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be administered. However, it is imperative not to exceed 6 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before administration.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of an allergic reaction 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 experiencing 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.

Ibuprofen should not be used in individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer, or in the immediate pre- or post-operative period following heart surgery.

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, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking diuretics should seek medical advice before using this product.

Patients under medical supervision for serious conditions or those taking aspirin for cardiovascular protection should also consult a healthcare provider before use, as ibuprofen may diminish the cardioprotective effects of aspirin. It is advisable to take ibuprofen with food or milk to mitigate potential stomach upset.

Patients should discontinue use and seek medical attention if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, patients should consult a healthcare professional.

For pregnant or breastfeeding individuals, it is crucial to seek guidance from a healthcare professional before use. Ibuprofen should be avoided during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the fetus or complicate delivery.

This medication must be kept out of reach of children. In the event of an overdose, immediate medical attention should be sought or contact with a Poison Control Center is recommended.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

Another significant concern is the risk of severe stomach bleeding, which is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using ibuprofen. Patients should be advised to avoid ibuprofen if they have previously experienced an allergic reaction to any pain reliever or fever reducer, or if they are undergoing heart surgery.

Common adverse reactions may include gastrointestinal discomfort, which can be mitigated by taking ibuprofen with food or milk. Patients should be instructed to discontinue use and seek medical attention if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Additionally, symptoms of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

Patients are also cautioned to consult a healthcare professional before using ibuprofen if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is important to note that ibuprofen may interfere with the cardioprotective effects of aspirin when taken concurrently for heart attack or stroke prevention.

In the context of pregnancy and breastfeeding, patients should seek advice from a healthcare provider prior to use, particularly during the last trimester of pregnancy, as ibuprofen may pose risks to the unborn child or complicate delivery.

In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, concurrent use of ibuprofen with aspirin for these indications is not recommended.

Additionally, the concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription, such as aspirin or naproxen, may elevate the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of gastrointestinal complications when these medications are used together.

Packaging & NDC

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

Packaging configurations for 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a dose of 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 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

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 healthcare professional before 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 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 and any potential risks associated with the medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate the overall health status of patients with compromised liver function before initiating therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame. In cases where specific antidotes are available, their use should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement these measures swiftly to ensure optimal patient outcomes in cases of overdose.

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 have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with overdose. Patients should be instructed to seek medical help or contact a Poison Control Center immediately in the event of an overdose. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

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 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.

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.