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Ibuprofen

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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 2012
Label revision date
October 9, 2012
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 2012
Label revision date
October 9, 2012
Manufacturer
Western Family Foods, Inc.
Registration number
ANDA079174
NDC root
55312-218
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen tablets are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve pain and reduce fever. You can use ibuprofen to temporarily alleviate minor aches and pains caused by headaches, muscular aches, toothaches, backaches, arthritis, menstrual cramps, and even discomfort from the common cold. Additionally, it can help lower a fever, making it a versatile option for managing various mild health issues.

Uses

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

This medication is designed to provide you with quick relief from these everyday discomforts, allowing you to feel more comfortable in your daily activities.

Dosage and Administration

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

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

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks.

Be cautious about the dosage; using more than directed or for longer than recommended can increase your risk of heart attack or stroke. Always follow the instructions provided to ensure your safety and well-being.

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, wheezing (asthma), 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, having bloody or black stools, or persistent stomach pain, it’s important to stop using ibuprofen and consult a doctor.

Before using ibuprofen, you should talk to your doctor if you have a history of serious side effects from pain relievers, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also crucial to inform your doctor if you are taking aspirin for heart protection, as ibuprofen may reduce its effectiveness.

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. Additionally, this medication can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use other NSAIDs.

Before using ibuprofen, consult your doctor if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also important to check with your doctor or pharmacist if you are taking aspirin for heart protection, as ibuprofen may reduce its effectiveness. If you suspect an overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222.

You should stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, seek medical advice if your pain worsens or lasts more than 10 days, your fever gets worse or lasts more than 3 days, or if you notice any new symptoms.

Overdose

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

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

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 the health of your baby by seeking professional advice.

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 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you can give 2 tablets. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 or older, there is a higher chance of experiencing severe stomach bleeding. To help prevent stomach upset, it’s recommended to take your medication with food or milk.

Additionally, be cautious about the dosage. Using more than the recommended amount or taking the medication for longer than directed can increase the risk of heart attack or stroke, especially in older adults. Always follow your healthcare provider's instructions closely to ensure your safety and well-being.

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 if you also have high blood pressure, heart disease, or liver cirrhosis, as these conditions can affect how your body processes the medication.

Always follow your doctor's advice regarding dosage and any necessary monitoring, especially if you have renal impairment (kidney issues). Taking these precautions can help ensure your safety and the effectiveness of your treatment.

Hepatic Impairment

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

Always inform your doctor about any existing health issues, including high blood pressure, heart disease, or kidney disease, as these can also affect how the medication works for you. Your well-being is a priority, so don't hesitate to reach out for guidance.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin, especially if you're using aspirin to help prevent heart attacks or strokes. This means that if you are prescribed aspirin for these reasons, you should discuss any use of ibuprofen with your healthcare provider.

Always talk to your doctor or pharmacist about all the medications you are taking, including over-the-counter drugs like ibuprofen, to ensure they work well together and to keep you safe.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F and 77°F). This temperature range helps maintain the product's effectiveness and safety.

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.

Additional Information

No further information is available.

FAQ

What is Ibuprofen Tablets used for?

Ibuprofen Tablets are used to temporarily relieve minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, menstrual cramps, and to reduce fever.

How should I take Ibuprofen Tablets?

Adults and children 12 years and older should take 1 tablet every 4 to 6 hours while symptoms persist. If needed, you can take 2 tablets, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

What should I do if I experience stomach bleeding?

Stop use and call your doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

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.

Can I use Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. 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?

You should ask a doctor before using Ibuprofen if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

What should I do if I am taking aspirin?

If you are taking aspirin to prevent heart attack or stroke, consult a doctor before using Ibuprofen, as it may decrease the effectiveness of aspirin.

What are the storage conditions for Ibuprofen Tablets?

Store Ibuprofen Tablets between 20°C - 25°C (68°F - 77°F).

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

Ibuprofen Tablets are nonsteroidal anti-inflammatory drugs (NSAIDs) indicated for the relief of pain and reduction of fever. These tablets are manufactured by Granules India Limited, located in Madhapur, Hyderabad, India, and are distributed by Western Family Foods, Inc., based in Portland, Oregon, USA. For complete warnings and product information, it is advised to retain the outer carton. Further details can be accessed at www.westernfamily.com.

Uses and Indications

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

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

Dosage and Administration

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

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

Contraindications

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

Warnings and Precautions

Ibuprofen may 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 they have experienced problems or serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have a history of gastrointestinal issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or those taking diuretics should seek medical advice before using ibuprofen.

Patients should also be cautioned to consult a doctor or pharmacist if they are taking aspirin for cardiovascular protection, as ibuprofen may diminish the antiplatelet effect of aspirin. Furthermore, individuals under medical supervision for serious conditions or those taking other medications should seek guidance before using this product.

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

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, redness or swelling in the affected area, or the emergence of any new symptoms.

Side Effects

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

Serious adverse reactions include the potential for severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Additionally, ibuprofen carries a warning for the risk of severe stomach bleeding, which is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications or steroids, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently.

Patients are advised to discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain that worsens. Other concerning symptoms warranting medical attention include pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling in the painful area, or the emergence of any new symptoms.

Common adverse reactions may include gastrointestinal discomfort, and patients should be cautious if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also recommended that patients consult a healthcare provider before using ibuprofen if they are taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in preventing heart attacks or strokes.

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

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to consider alternative analgesics that do not interfere with aspirin's efficacy in such clinical scenarios. Monitoring for cardiovascular outcomes may be warranted in patients receiving both medications.

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 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. It is advisable for geriatric patients to take the medication with food or milk to mitigate potential stomach upset.

Additionally, there is a heightened risk of heart attack or stroke associated with the use of this medication, especially if it is taken in higher doses or for an extended duration than recommended. Careful monitoring and adherence to prescribed dosages are essential for elderly patients to minimize these risks.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is especially important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the risks when considering the use of this medication in pregnant patients.

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 explicitly 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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for patients with compromised liver function to receive appropriate medical guidance to ensure safe and effective use of the medication. Monitoring of liver function may be necessary, and any dosage adjustments should be made based on the healthcare provider's assessment of the patient's overall health status and liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop as a result of the overdose.

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 specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

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, cases of stomach bleeding have been reported, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, there is an observed increase in the risk of heart attack or stroke associated with prolonged use or higher than directed doses. Reports of gastrointestinal adverse events, including ulcers and bleeding, have also been noted in the postmarketing experience.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed that if they experience stomach upset, it is recommended to take the medication with food or milk to alleviate discomfort.

Additionally, it is important to discuss the potential risks associated with the medication, specifically that the risk of heart attack or stroke may increase if the patient uses more than the directed dosage or for a duration longer than prescribed.

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 within the temperature range of 20°C to 25°C (68°F to 77°F) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

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.

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.