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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, Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
May 16, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
May 16, 2013
Manufacturer
Velocity Pharma
Registration number
ANDA091239
NDC root
76168-012
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

This medication is designed to temporarily relieve minor aches and pains, such as those caused by headaches, toothaches, backaches, menstrual cramps, arthritis, muscular aches, and even discomfort from the common cold. Additionally, it can help reduce fever for a short period.

If you're experiencing any of these types of pain or fever, this medication may provide you with the relief you need. Always consult with a healthcare professional for guidance on its use and to ensure it's appropriate for your situation.

Uses

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

It's important to note that this medication does not have any teratogenic effects, meaning it does not cause birth defects.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should not take more than the directed amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 to 6 hours as needed while symptoms persist. If you find that 1 tablet isn't enough to relieve your pain or fever, you can take 2 tablets instead.

However, be cautious not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. If you have a child under 12 years old, it's essential to consult a doctor before giving them this medication. Always prioritize safety and consult with a healthcare professional if you have any questions or concerns.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

This product may cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, it contains a nonsteroidal anti-inflammatory drug (NSAID), which can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume alcohol regularly, or use other NSAIDs.

You should avoid using this product if you have ever had an allergic reaction to pain relievers or fever reducers, or if you are about to undergo heart surgery. Consult your doctor before use if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. If you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop using the product and seek medical attention immediately. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before use, especially during the last three months of pregnancy.

Warnings and Precautions

This product may cause a severe allergic reaction, particularly if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the product immediately and seek medical help.

Be cautious 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 ibuprofen. It's important to take this product with food or milk to help reduce the risk of stomach issues. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop using the product and contact your doctor right away. Additionally, consult your doctor before use if you have high blood pressure, heart disease, liver or kidney issues, or asthma, or if you are pregnant or breastfeeding.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

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 specifically instructed by your doctor, 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 advice.

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 your child is under 12 years old, it's important to consult with a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets, but be sure not to exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. 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 affect the stomach.

Always consult with your healthcare provider about any medications you are considering or currently taking. They can help you understand the risks and adjust dosages or suggest alternatives that are safer for older adults. Your health and safety are the top priority, so don't hesitate to ask questions and seek guidance.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis, and asthma can complicate your kidney issues. It's essential to monitor your kidney function regularly, especially if you are taking medications that may impact your kidneys.

Make sure to discuss any necessary dosage adjustments with your healthcare provider, as they may need to modify your treatment based on your kidney function. Keeping an open line of communication with your doctor will help ensure that your health is managed effectively.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or monitor your liver function closely. This is because your liver plays a crucial role in processing medications, and any impairment can change how your body responds to them.

Make sure to communicate openly with your doctor about your liver condition and any other health issues you may have, such as high blood pressure, heart disease, kidney disease, or asthma. This information will help them provide you with the safest and most effective care tailored to your needs.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin, especially if you're using aspirin to prevent heart attacks or strokes. This means that if you are prescribed aspirin for these serious health issues, 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. This way, you can ensure that your treatments work effectively and safely together.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25 °C (68-77 °F). It's important to avoid exposing it to excessive heat, which can occur if the temperature exceeds 40 °C (104 °F).

When handling the product, check that the safety seal under the cap is intact. If the seal is broken or missing, do not use the product, as this may compromise its safety. 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 with 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 can lead to issues for the unborn child or complications during delivery.

FAQ

What is this drug used for?

This drug temporarily relieves minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, minor arthritis pain, muscular aches, and the common cold. It also temporarily reduces fever.

What should I do if I experience severe allergic reactions?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using the product and seek medical help immediately.

What are the dosage instructions for adults and children over 12?

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

Are there any warnings I should be aware of?

Yes, this product may cause severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or take certain medications. Consult your doctor if any of these apply to you.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is particularly important not to use this drug during the last 3 months of pregnancy unless directed by a doctor.

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

Stop using the product and contact your doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

What should I do if I am under 12 years old?

If you are under 12 years old, you should ask a doctor before using this product.

How should I store this medication?

Store the medication 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 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

The product is identified by the National Drug Code (NDC) 76168-012-08 and is available in a quantity of 40 count.

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, minor pains of arthritis, muscular aches, and discomfort related to the common cold. Additionally, this drug 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 administration guidelines. 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 otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

This product may cause a severe allergic reaction, particularly in individuals with a known allergy to aspirin. Symptoms of an allergic reaction may 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.

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

This product should not be used by 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 be consulted prior to use if the following conditions apply: a history of stomach bleeding, previous serious side effects from pain relievers or fever reducers, a history of gastrointestinal issues such as heartburn, or existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Additionally, it is advisable to consult a doctor or pharmacist before use if the patient is under medical care for any serious condition, is taking aspirin for the prevention of heart attack or stroke (as ibuprofen may diminish the efficacy of aspirin), or is using any other medications.

When administering this product, it is recommended to take it with food or milk to mitigate gastrointestinal irritation. Caution should be exercised, as the risk of heart attack or stroke may increase if the product is taken in excess of the recommended dosage or for an extended period.

Patients should discontinue use and seek medical advice 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 longer than 10 days. Additionally, if fever worsens or persists beyond three days, or if redness or swelling occurs in the painful area, medical consultation is warranted. Any new symptoms that arise should also prompt a discussion with a healthcare provider.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before use. Special caution is advised against the use of ibuprofen during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Side Effects

This product may cause serious adverse reactions, including severe allergic reactions and gastrointestinal complications. Patients with a known allergy to aspirin may experience symptoms such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), is 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 the product, or exceed the recommended dosage or duration of use.

Patients should not use this product if they have previously experienced an allergic reaction to any pain reliever or fever reducer, or if they are undergoing heart surgery. It is advised that patients consult their healthcare provider before use if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if they are under medical care for any serious condition. Additionally, patients taking aspirin for cardiovascular protection should be aware that ibuprofen may diminish the effectiveness of aspirin.

While using this product, it is recommended to take it with food or milk to mitigate gastrointestinal irritation. Patients should be vigilant for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or noticing any new symptoms. If any of these symptoms occur, patients should discontinue use and seek medical attention.

For pregnant or breastfeeding patients, it is crucial to consult a healthcare professional before use. The use of ibuprofen during the last trimester of pregnancy is particularly discouraged unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

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 monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

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. The maximum allowable dosage is 6 tablets within a 24-hour period, unless otherwise 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 when treating this population to ensure optimal safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of ibuprofen during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the developing fetus or complications during delivery. Therefore, it is essential that pregnant patients only use ibuprofen in this period if explicitly directed by a healthcare provider.

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 doctor, 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, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or asthma, it is essential to evaluate renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy, as changes in clearance may impact drug metabolism and excretion. Healthcare professionals should exercise caution and consider potential dose modifications based on the severity of renal impairment and the specific pharmacokinetics of the medication being prescribed.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with significant liver disease, particularly those with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy. Patients with compromised liver function should be closely observed for any signs of adverse reactions or changes in therapeutic response.

Due to the potential for increased risk of side effects, it is advised that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed 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

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports indicate occurrences of gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which include anaphylaxis and various skin reactions. Additionally, serious cardiovascular events, such as myocardial infarction and stroke, have been reported.

There have been instances of liver enzyme elevations and cases of liver failure noted in the postmarketing data. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Furthermore, reports have indicated asthma exacerbation in patients with a prior history of asthma, as well as cases of hypertension and fluid retention.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25 °C (68-77 °F). Care must be taken to avoid exposure to excessive heat, as temperatures above 40 °C (104 °F) may compromise the integrity of the product.

Additionally, it is imperative that the product is not used if the imprinted safety seal under the cap is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are essential to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. 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, 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.