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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
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
February 15, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 1999
Label revision date
February 15, 2017
Manufacturer
Breeden Brothers, LLC
Registration number
ANDA075139
NDC root
70729-002
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains, such as those caused by backaches, muscular aches, arthritis, headaches, menstrual cramps, toothaches, and even discomfort from the common cold. Additionally, it helps to reduce fever, providing you with comfort when you're not feeling your best.

While the specific mechanism of action isn't detailed, you can trust that this medication is formulated to help alleviate your discomfort and improve your overall well-being during times of minor pain or illness.

Uses

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

This medication is designed to provide you with quick relief from these everyday discomforts, making it easier for you to go about your daily activities. Always remember to follow the recommended guidelines for use.

Dosage and Administration

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

For children under 12 years 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, do not take it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in individuals allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication 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 three or more alcoholic drinks daily, or use it for longer than recommended. 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, vomiting blood, or having bloody or black stools. 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, high blood pressure, heart disease, or are taking other medications, especially aspirin for heart conditions, as ibuprofen may reduce its effectiveness.

Warnings and Precautions

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

This medication can also lead to severe 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 other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal.

You should get emergency medical help if you suspect an overdose or contact a Poison Control Center at 1-800-222-1222. Stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding (such as feeling faint, vomiting blood, or having black stools), symptoms of heart problems or stroke (like chest pain or slurred speech), if your pain worsens or lasts more than 10 days, if your fever worsens or lasts more than 3 days, or if you develop any new symptoms or notice redness or swelling in the painful area.

Overdose

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

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help if you think an overdose has occurred.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. During the last three months of pregnancy, you should avoid using ibuprofen unless your doctor specifically advises you to do so, as it can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, as using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult 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 guidance if you have any questions about your child's health.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 or older, you should know that the risk of severe stomach bleeding increases with age. This means that if you experience any unusual stomach pain or discomfort while taking certain medications, you should seek medical advice promptly.

Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs), which are commonly used for pain relief, can raise the risk of heart attack, heart failure, and stroke, especially if taken in higher doses or for longer than recommended. Before starting any new medication, it's wise to consult with your doctor, particularly if you are over 60 and have concerns about stomach bleeding or other health issues. Your healthcare provider can help ensure that you use medications safely and effectively.

Renal Impairment

If you have kidney disease or other health conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, it's important to be cautious with your medications. Additionally, if you are taking a diuretic (a type of medication that helps your body get rid of excess fluid), you should be particularly mindful of how it may affect your kidney function.

Always consult your healthcare provider for guidance on medication adjustments and monitoring, as they can help ensure that your treatment is safe and effective given your kidney health. Regular check-ups and open communication with your doctor are key to managing your condition effectively.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be cautious with certain medications. Your healthcare provider may need to adjust your dosage or monitor your liver function closely. This is to ensure that the medication is safe and effective for you, as your liver plays a crucial role in processing many drugs.

Always inform your doctor about your liver condition, as well as any other health issues you may have, like high blood pressure or heart disease. This information helps them make the best decisions regarding your treatment plan.

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 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, which can occur at temperatures above 40°C (104°F). Always check the expiration date on the package and make sure to use the product before that date.

When handling the product, be cautious of its packaging. If the outer package is opened or if the blister (the sealed compartment that holds the product) is torn or broken, do not use it. This tamper-evident feature is designed to protect you, so always ensure the packaging is intact before use.

Additional Information

No further information is available.

FAQ

What is the primary use of this medication?

This medication temporarily relieves minor aches and pains from conditions like backache, muscular aches, arthritis, headache, menstrual cramps, toothache, 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 medication 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, not exceeding 6 tablets in 24 hours unless directed by a doctor.

Are there any warnings regarding stomach bleeding?

Yes, this medication contains an NSAID, which may cause severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or take blood thinners.

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

If you feel faint, vomit blood, or have bloody or black stools, stop using the medication and contact a doctor immediately.

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

If you are pregnant or breastfeeding, consult a health professional before use, especially during the last 3 months of pregnancy.

What should I do if pain or fever persists?

If pain worsens or lasts more than 10 days, or if fever lasts more than 3 days, stop use and consult a doctor.

How should I store this medication?

Store the medication 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

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, muscular aches, minor pain of arthritis, headache, menstrual cramps, toothache, and discomfort related to the common cold. 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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased 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 concurrently using anticoagulants or steroid medications, are taking 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.

NSAIDs, excluding aspirin, are also linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended dosage or for prolonged periods.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center (1-800-222-1222) without delay.

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, 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. Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if any new symptoms arise, or if there is redness or swelling in the affected area.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding, especially 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, or exceed the recommended dosage or duration of use.

The use of NSAIDs, excluding aspirin, is also associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used inappropriately, such as taking more than directed or for an extended period.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or 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.

Patients should seek medical advice before using ibuprofen if they have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended that individuals taking diuretics or those who have experienced serious side effects from pain relievers or fever reducers consult a healthcare provider prior to use. Furthermore, patients under a doctor's care for serious conditions or those taking other medications, particularly aspirin for heart attack or stroke prevention, should discuss the use of ibuprofen with their doctor or pharmacist, as it may diminish the cardioprotective effects of aspirin.

Patients are encouraged to monitor their symptoms closely and to seek medical attention if pain persists beyond 10 days, fever worsens or lasts more than 3 days, new symptoms arise, or if there is redness or swelling in the affected area.

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 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, 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 when using this medication. It is essential for healthcare providers to exercise caution and consider this heightened risk when prescribing to geriatric patients.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an elevated risk of heart attack, heart failure, and stroke. This risk is further amplified if the medication is used in dosages exceeding the recommended limits or for durations longer than advised.

Healthcare providers should advise elderly patients to consult with a physician prior to initiating treatment, especially if they are 60 years of age or older and are concerned about the potential for stomach bleeding. Close monitoring and appropriate dose adjustments may be necessary to ensure the safety and efficacy of treatment in this population.

Pregnancy

Pregnant patients 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 unborn child and lead to complications during delivery. The potential fetal impacts associated with ibuprofen use in late pregnancy warrant careful consideration and professional guidance. Additionally, breastfeeding women should also seek advice from a healthcare provider prior to use.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment 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 kidney disease, the pharmacokinetics of the medication may be altered.

It is essential to monitor renal function closely in patients who are also taking diuretics, as these medications can further impact kidney performance. Adjustments to the dosing regimen may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis or significant hepatic impairment, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Patients with a history of liver disease, including cirrhosis, should be evaluated carefully, as the presence of hepatic impairment may necessitate restrictions on the use of this medication. It is crucial to consider the overall health status of patients, particularly those with concurrent conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these factors may further complicate treatment decisions.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

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 will depend on the substance involved and the severity of the symptoms presented.

It is essential to follow established protocols for overdose management, which may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is recommended to ensure appropriate interventions are implemented in a timely manner.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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 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 reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including manifestations such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning (anticoagulant) or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. The risk of stomach bleeding may also increase with prolonged use or higher than directed dosages.

Furthermore, there is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with the use of NSAIDs. These events can be fatal, particularly when the medication is used beyond the recommended duration or dosage.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be instructed to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if they are subject to stomach bleeding warnings. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously experienced a stroke.

Patients should also be advised to consult a doctor before use if they are currently taking a diuretic or if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Furthermore, patients under a doctor's care for any serious condition should seek guidance from their healthcare provider or pharmacist prior to using the medication.

Lastly, patients should be encouraged to inform their healthcare provider or pharmacist about any other medications they are taking, including aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin in these situations.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to inspect the outer package for any signs of tampering, such as an opened outer package or a torn or broken blister, as these conditions indicate that the product should not be used.

Storage conditions require that the product be maintained at a temperature between 20°-25°C (68°-77°F). It is crucial to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). The expiration date indicated on the package must be adhered to, ensuring the product is used within the specified timeframe for optimal safety and efficacy.

Additional Clinical Information

No further data are available.

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.