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Pain Relief

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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 15, 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 15, 2012
Manufacturer
Select Corporation
Registration number
ANDA091239
NDC root
52904-447
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 commonly used to temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. It is also effective for alleviating pain associated with arthritis and the common cold. In addition to pain relief, ibuprofen temporarily reduces fever, making it a versatile option for managing discomfort and fever symptoms.

Uses

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

This medication is designed to provide you with quick relief from discomfort, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. You should never take more than what is directed, and it's best to use the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the recommended dose is to take 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, make sure 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 with a doctor before giving them this medication. Always prioritize safety and follow the guidance provided by healthcare professionals.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding 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

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 any signs 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 immediately. It's important to talk to your healthcare provider before using ibuprofen if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if you are taking other medications.

Warnings and Precautions

You should be aware that ibuprofen can cause severe allergic reactions, especially if you are allergic to aspirin. Symptoms of an allergic reaction 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 serious 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 it for longer than directed. It's important to consult your doctor before using ibuprofen if you have any history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, if you are taking aspirin for heart attack or stroke prevention, check with your doctor, as ibuprofen may reduce the effectiveness of aspirin.

You should stop using ibuprofen and contact your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or if your stomach pain worsens or lasts more than 10 days. Also, seek medical advice if your fever worsens or lasts more than three days, or if you notice any new symptoms.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel uncertain, 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 professional assistance if you think you or someone else may have taken too much of a medication. Remember, timely intervention can be crucial.

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. 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 effective for pain or fever, you may give 2 tablets, but be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise.

Always keep this medication out of reach of children to ensure their safety.

Geriatric Use

As you age, it's important to be aware of certain health risks when taking medications. If you are 60 or older, you may have a higher chance of experiencing severe stomach bleeding. This risk is especially significant if you have a history of stomach issues, such as heartburn, or conditions like high blood pressure, heart disease, liver cirrhosis (a liver condition), or kidney disease.

Before starting any new medication, it's wise to consult with your doctor, particularly if you fall into this age group or have any of the mentioned health concerns. Your doctor can help ensure that the medication is safe for you and discuss any necessary precautions.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your doctor will help determine if it's safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

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 can help determine if it's safe for you, especially if you also have other conditions like high blood pressure or heart disease.

Always prioritize your health by discussing any existing liver issues with your doctor to ensure proper care and monitoring.

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 rely on aspirin for your heart health, you should be cautious about using ibuprofen alongside it.

Always talk to your healthcare provider or pharmacist before starting any new medication, including over-the-counter drugs like ibuprofen. They can help you understand potential interactions with any other medications you may be taking, ensuring your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the product protected from light to maintain its quality. Always keep it out of reach of children to prevent accidental ingestion or misuse. Once you open the product, remember to discard it after use to avoid any potential risks associated with contamination or degradation.

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 is Ibuprofen used for?

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

What is the recommended dosage 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, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. It can also cause stomach bleeding, particularly in individuals over 60 or those with a history of stomach problems.

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

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

Can I use 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, high blood pressure, heart disease, liver cirrhosis, or kidney disease, ask a doctor before using Ibuprofen.

How should I store Ibuprofen?

Store Ibuprofen at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Pain Relief, 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) indicated for the relief of pain. It is available in a packet form, which contains individual doses for convenient administration. The active ingredient, ibuprofen, is known for its analgesic and anti-inflammatory properties. The formulation is designed to provide effective pain relief while minimizing gastrointestinal side effects commonly associated with NSAIDs.

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

The medication should be administered according to the following guidelines to ensure safety and efficacy.

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 dose of 2 tablets may be taken. However, 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 advised to consult a doctor for appropriate dosing recommendations.

Healthcare professionals should emphasize the importance of using the smallest effective dose and adhering strictly to the prescribed dosage to avoid potential adverse effects.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 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, 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 by individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer, nor should it be administered immediately before or after heart surgery.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen 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 use.

Patients should also be cautioned to consult a doctor or pharmacist if they are taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin. Furthermore, individuals under medical supervision for serious conditions or those taking other medications should seek guidance before using ibuprofen.

When administering this product, it is recommended to take it with food or milk to mitigate potential stomach upset. It is important to note that the risk of heart attack or stroke may increase with the use of ibuprofen beyond the directed dosage or duration.

Patients should be instructed to discontinue use and consult a healthcare professional 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 advice should be sought. Any new symptoms that arise should also prompt a consultation with a healthcare provider.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions and gastrointestinal complications.

Severe allergic reactions may occur, 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.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the risk of severe stomach bleeding. The likelihood of this adverse reaction is increased 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 not to use ibuprofen if they have previously experienced an allergic reaction to any other pain reliever or fever reducer, or if they are scheduled for heart surgery. It is also recommended that patients consult a healthcare provider prior to use if they have a history of serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning applies to them.

Other conditions that warrant consultation with a healthcare provider before using ibuprofen include a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Patients taking diuretics or aspirin for cardiovascular protection should also seek medical advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

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

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. This interaction is particularly relevant for patients who rely on aspirin for its antiplatelet properties.

Patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to using ibuprofen in conjunction with any other medications. This precaution is essential to ensure safe and effective use, as potential interactions may vary based on individual health conditions and concurrent therapies.

Packaging & NDC

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

Packaging configurations for Pain Relief.
Details

Pediatric Use

Children under 12 years of age should consult a doctor before use. 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, 2 tablets may be administered. However, the total dosage must not exceed 6 tablets in a 24-hour period unless directed by a healthcare professional. It is important to keep this medication out of reach of children.

Geriatric Use

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

Before initiating treatment, healthcare providers should inquire about any history of stomach problems, including heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease, especially in geriatric patients. Such medical histories may necessitate careful monitoring and potential dosage adjustments to ensure patient safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. There is limited data regarding the excretion of this medication in breast milk and its effects on breastfed infants. Caution is particularly warranted during the last three months of pregnancy, as the use of ibuprofen in this period may lead to complications for the unborn child or during delivery. Therefore, healthcare providers should carefully evaluate the risks and benefits when considering this medication for 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 the 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 these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

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

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

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

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in their home environment.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light exposure. Additionally, it is crucial to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product should be discarded to ensure safety and efficacy.

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 Pain Relief, 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 Relief, 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.