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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
December 12, 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
December 12, 2025
Manufacturer
Walgreen Company
Registration number
ANDA075139
NDC root
0363-0438
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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

Drug Overview

Ibuprofen is a medication that comes in 200 mg tablets and is commonly used as a pain reliever and fever reducer. It belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). You can take ibuprofen to temporarily relieve minor aches and pains caused by headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. Additionally, it helps to lower fever.

This medication is recommended by pharmacists and is dye-free, making it a suitable option for many people seeking relief from discomfort. Always ensure that the safety seal under the cap is intact before use.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even minor arthritis pain. It can also help ease discomfort associated with the common cold.

In addition to pain relief, this medication is effective in temporarily reducing fever. It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

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. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

If you are considering this medication for a child under 12 years old, it's essential to consult with a doctor first to determine the appropriate dosage. Always prioritize safety and follow the guidance provided by healthcare professionals.

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 this medication right before or after undergoing heart surgery, as it may pose risks to your health. Always consult with your healthcare provider if you have any concerns or questions about your specific situation.

Side Effects

Using ibuprofen can lead to some serious side effects that you should be aware of. It may cause severe allergic reactions, especially if you are allergic to aspirin. Symptoms can include rash, facial swelling, asthma (wheezing), hives, skin reddening, shock, and blisters. Additionally, ibuprofen is an NSAID (nonsteroidal anti-inflammatory drug) that can increase the risk of severe stomach bleeding, particularly if you take it for longer than recommended, are over 60, have a history of stomach ulcers, or consume alcohol regularly.

There is also a risk of heart attack and stroke associated with NSAIDs, which can be fatal. This risk increases if you exceed the recommended dosage or duration of use. If you experience symptoms like faintness, bloody or black stools, chest pain, or weakness on one side of your body, you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have a history of stomach issues, heart disease, or are taking other medications.

Warnings and Precautions

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

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.

Be aware of signs that require you to stop using ibuprofen and consult your doctor, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain, slurred speech, or weakness on one side of your body. If your pain worsens or lasts more than 10 days, or if you have a fever that persists for more than three days, contact your healthcare provider. In case of an overdose, get emergency medical help or contact a Poison Control Center right away.

Overdose

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

Don’t wait for symptoms to worsen; acting quickly can be vital. Always keep emergency contact information handy, and remember that your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including 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 seek guidance from your doctor to ensure the safety of both you and your baby.

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 with a doctor before using 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 instead. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek professional guidance when it comes to treating your child's health.

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. To help minimize this risk, it is recommended that you take the smallest effective dose of your medication. Additionally, your doctor may need to adjust your dosage, as older adults often have a heightened sensitivity to side effects. Always consult with your healthcare provider to ensure that your treatment is safe and effective for your specific needs.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). It's important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), as this can affect its effectiveness.

Additionally, always check the end flap for the expiration date and lot number to ensure you are using a safe and effective product. Proper handling and storage are key to maintaining the quality and safety of your device.

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 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.

FAQ

What is Ibuprofen used for?

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

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

If you feel faint, have bloody or black stools, vomit blood, or have stomach pain that does not improve, stop using Ibuprofen and ask a doctor 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. Do not exceed 6 tablets in 24 hours unless directed by a doctor.

Can I take 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 Ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I have an allergic reaction to Ibuprofen?

If you experience symptoms like rash, facial swelling, or difficulty breathing, stop using Ibuprofen and seek medical help right away.

Are there any contraindications for using Ibuprofen?

Do not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever or fever reducer, or if you are using it right before or after heart surgery.

What should I do if I have kidney disease?

If you have kidney disease, ask a doctor before using Ibuprofen.

How should I store Ibuprofen?

Store Ibuprofen between 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 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)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

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

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. However, the total daily dosage must 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.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks to surgical outcomes and patient safety.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may 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 is associated with an increased risk of severe stomach bleeding. The likelihood of such an event is heightened under certain conditions, including prolonged use beyond the recommended duration, concurrent use of blood-thinning agents (anticoagulants) or steroid medications, being aged 60 years or older, a history of stomach ulcers or bleeding disorders, consumption of three or more alcoholic beverages daily while using this product, and the use of other medications containing NSAIDs (such as aspirin, ibuprofen, or naproxen).

Healthcare professionals should be aware that NSAIDs, excluding aspirin, elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced with dosages exceeding the recommended limits or with extended use.

In cases of suspected overdose, immediate medical attention is required. Contacting a Poison Control Center is also advised.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, warrant immediate medical evaluation.

Further, if pain persists or worsens 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 more than the recommended dose or for an extended duration. Additional risk factors include concurrent use of blood thinners or steroid medications, being aged 60 or older, having a history of stomach ulcers or bleeding problems, consuming three or more alcoholic drinks daily while using the product, and taking other NSAIDs, whether prescription or over-the-counter, such as aspirin or naproxen.

Furthermore, the use of NSAIDs, including ibuprofen, has been linked to 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 longer than directed.

Patients are advised to discontinue use and consult a healthcare professional if they experience any 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. Additionally, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

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 to inform the healthcare provider if the patient is under medical care for any serious condition or is taking aspirin for heart attack or stroke prevention, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. Therefore, it is recommended that healthcare providers prescribe the smallest effective dose to minimize this risk.

Additionally, dosage adjustments may be necessary for geriatric patients due to their heightened sensitivity to side effects. Careful monitoring and consideration of individual patient factors are essential when determining the appropriate dosage for this population.

Pregnancy

Pregnant patients and women 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.

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 renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 tests may be warranted to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

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

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

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols as necessary, ensuring the safety and well-being of the patient.

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 specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have included gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious cardiovascular events, such as myocardial infarction and stroke, have also been reported. Additionally, cases of severe allergic reactions, including anaphylaxis and angioedema, have been documented.

Other adverse reactions noted in postmarketing data encompass skin reactions, specifically Stevens-Johnson syndrome and toxic epidermal necrolysis. There have been instances of elevated blood pressure in patients taking ibuprofen. Furthermore, postmarketing surveillance has indicated that some patients may experience dizziness or headache as side effects.

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 to ensure their safety and well-being.

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° to 25°C (68° 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

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 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.

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.

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.