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Dye Free Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film 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 1999
Label revision date
August 26, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film 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 1999
Label revision date
August 26, 2025
Manufacturer
Walgreen Company
Registration number
ANDA075139
NDC root
0363-4381
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 dye-free pain reliever and fever reducer available in 200 MG tablets. It belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). You can use ibuprofen to temporarily relieve minor aches and pains caused by headaches, backaches, the common cold, arthritis, toothaches, menstrual cramps, and muscular aches. Additionally, it helps to temporarily reduce fever.

This medication is recommended by pharmacists and is comparable to the active ingredient found in Motrin® IB Tablets. If you're looking for a way to manage pain or reduce fever, ibuprofen may be a suitable option for you.

Uses

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

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication.

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 to do so.

For children under 12 years of age, it’s best to consult with 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. Always consult with your healthcare provider if you have any concerns or questions about your eligibility to use this medication. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in those allergic to aspirin. Symptoms of an allergic reaction may include rash, facial swelling, asthma (wheezing), hives, skin reddening, shock, and blisters. Additionally, this medication can lead to severe stomach bleeding, especially if you take it for longer than recommended, are over 60, have a history of stomach ulcers, or consume alcohol regularly. There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, having bloody or black stools, or vomiting blood. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain or slurred speech. It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, are taking certain medications, or have conditions like high blood pressure or kidney disease.

Warnings and Precautions

You should be aware that ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms of an allergic reaction may include rash, facial swelling, wheezing, hives, skin reddening, shock, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication can also lead to severe stomach bleeding, particularly if you take it for longer than recommended, are over 60, have a history of stomach ulcers, or consume three or more alcoholic drinks daily while using it. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods. Before using ibuprofen, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, or are taking other medications.

If you experience signs of stomach bleeding, such as feeling faint, having bloody or black stools, or vomiting blood, stop taking ibuprofen and call your doctor. Seek immediate medical help if you notice symptoms of heart problems or stroke, such as chest pain, slurred speech, or trouble breathing. Also, contact your doctor if your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days.

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 typical side effects.

Always err on the side of caution—if you or someone else is experiencing concerning symptoms after taking medication, don’t hesitate to reach out for professional assistance. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using ibuprofen. This is particularly important if you are 20 weeks pregnant or later, 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 ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to 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.

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, 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, but be careful not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

If you are an older adult or caring for one, it's important to be aware of certain risks when using this medication. It contains a type of pain reliever known as an NSAID, which can increase the risk of severe stomach bleeding, especially for those aged 60 and older.

Before using this product, you should consult with a doctor if you have any of the following conditions: high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, asthma, or if you have previously had a stroke. Taking these precautions can help ensure safer use of the medication.

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, liver cirrhosis (a severe liver condition), asthma, or a history of stroke. Your doctor can help determine if this medication is safe for you and whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health by discussing any concerns with your healthcare provider.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe liver scarring), 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 other health issues you may have, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these can also affect your treatment plan. Your well-being is the priority, so open communication with your healthcare team is essential.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin, especially when aspirin is used to prevent heart attacks or strokes. Additionally, if you are on blood thinners (anticoagulants) or steroids, there is a higher risk of stomach bleeding.

Before starting any new medication, including over-the-counter drugs, you should consult with your healthcare provider, especially if you are taking diuretics or have conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Always discuss any other medications you are taking with your doctor or pharmacist to ensure your safety and well-being.

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). It's important to avoid exposing it to excessive heat, which can occur at temperatures above 40°C (104°F).

Before using the product, check the end flap for the expiration date and lot number to confirm its safety and effectiveness. Proper storage and handling are key to maintaining the quality of the product, so please follow these guidelines closely.

Additional Information

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it may pose risks to your unborn child or lead to complications during delivery.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center for help.

FAQ

What is Ibuprofen?

Ibuprofen is a dye-free pain reliever and fever reducer available in 200 MG tablets. It belongs to a class of drugs known as NSAIDs (nonsteroidal anti-inflammatory drugs).

What does Ibuprofen temporarily relieve?

Ibuprofen temporarily relieves minor aches and pains from headaches, backaches, the common cold, arthritis, toothaches, menstrual cramps, and muscular aches. It also temporarily reduces fever.

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

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

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

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if you have a history of stomach problems or are taking other medications.

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 at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

What should I avoid while taking Ibuprofen?

Avoid taking Ibuprofen if you have had an allergic reaction to any pain reliever/fever reducer or if you are about to undergo heart surgery. Also, limit alcohol consumption and consult a doctor if you are taking blood thinners or have certain health conditions.

Packaging Info

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

Packaging configurations for Dye Free Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Dye Free Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, backache, the common cold, minor pain of arthritis, toothache, menstrual cramps, and muscular aches. 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 over 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, administration is contraindicated 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 rash, facial swelling, asthma (wheezing), hives, skin reddening, shock, 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 increases under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, being aged 60 years or older, having a history of stomach ulcers or bleeding disorders, consuming three or more alcoholic beverages daily while using this product, or taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for an extended period.

Before prescribing or recommending ibuprofen, it is advisable to consult a physician if any of the following conditions apply: a history of stomach bleeding, previous stomach issues such as heartburn, current use of diuretics, or pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients should be advised to consult a healthcare provider if they are under treatment for any serious medical condition, are taking aspirin for cardiovascular protection (as ibuprofen may diminish the efficacy of aspirin), or are using any other medications.

In the case of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue ibuprofen and contact their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, also 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 seek medical advice promptly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include rash, facial swelling, asthma (wheezing), hives, skin reddening, shock, and blisters.

The use of ibuprofen is associated with an increased risk of severe stomach bleeding, particularly in patients who take higher doses or use the medication for extended periods. This risk is further elevated in individuals who are older than 60 years, have a history of stomach ulcers or bleeding problems, consume three or more alcoholic drinks daily, or are concurrently using blood thinners (anticoagulants) or steroid medications.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries warnings regarding the potential for heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events increases with higher doses or prolonged use.

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

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, such as heartburn, or if they are taking diuretics, have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients under a doctor's care for serious conditions or those taking aspirin for heart attack or stroke prevention to discuss their use of ibuprofen, as it may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, concurrent use of these medications should be approached with caution.

The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

Patients taking diuretics should consult a healthcare professional prior to using ibuprofen, as potential interactions may necessitate monitoring or dosage modifications.

Individuals with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke are advised to seek medical advice before initiating ibuprofen therapy.

Furthermore, it is recommended that patients consult with a healthcare provider or pharmacist before using ibuprofen in conjunction with any other medications to ensure safety and efficacy.

Packaging & NDC

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

Packaging configurations for Dye Free 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, may have an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). Therefore, caution is advised when prescribing this medication to geriatric patients.

It is essential for healthcare providers to assess the overall health status of elderly patients prior to initiating treatment. Patients with a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a previous stroke should consult with their healthcare provider before using this product. Monitoring for potential adverse effects is recommended to ensure patient safety and to make any necessary dose adjustments based on individual health conditions.

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 after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully consider the potential benefits and risks when prescribing this medication to pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, 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 during lactation.

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 status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no reported adverse events or case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20 ̊C to 25 ̊C (68 ̊F to 77 ̊F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40 ̊C (104 ̊F). For tracking purposes, the expiration date and lot number are located on the end flap of the packaging. Proper handling and storage conditions are crucial to maintain the integrity of the product.

Additional Clinical Information

No additional information is available regarding laboratory tests, abuse information, or postmarketing experience.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly crucial to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Dye Free 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 Dye Free 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.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.