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Clear Choice Ibuprofen

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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
November 7, 2016
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
November 7, 2016
Manufacturer
Athlete's Needs Inc
Registration number
ANDA079129
NDC root
53185-003
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 modern pain relief medication that helps temporarily relieve minor aches and pains, including headaches, muscular aches, toothaches, backaches, and menstrual cramps. It is also effective in reducing fever and can be used for discomfort associated with the common cold and minor arthritis pain. Importantly, ibuprofen does not contain aspirin and is caffeine-free, making it a suitable option for many individuals seeking relief from pain and fever.

Uses

You can use this medication to temporarily relieve minor aches and pains from various conditions. This includes headaches, muscular aches, minor arthritis pain, toothaches, backaches, and discomfort from the common cold. It can also help ease menstrual cramps and reduce fever for a short period.

This medication is designed to provide you with quick relief, making it easier to manage everyday discomforts. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

When using this medication, it’s important to follow the directions carefully. You should take the smallest effective dose to manage your symptoms, and avoid using it for more than 10 days unless your doctor advises otherwise. For adults and children aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If you find that 1 tablet isn’t enough to relieve your pain or fever, you can take 2 tablets instead. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor tells you to do so.

If you have a child under 12 years old, it’s best to consult with a doctor before giving them this medication. Always remember to take it as directed to ensure your safety and effectiveness of the treatment.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to other pain relievers or fever reducers. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious risks to your health.

Be cautious about the dosage; using more than directed or for longer than recommended can increase your risk of heart attack or stroke. Always follow the instructions provided to ensure your safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs 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, with a history of stomach ulcers or bleeding, or who are taking blood thinners or other NSAIDs. Drinking three or more alcoholic beverages daily while using ibuprofen can also increase this risk.

You should stop using ibuprofen and consult a doctor if you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. If your pain worsens or lasts more than 10 days, or if you develop a fever that lasts more than three days, seek medical advice. It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if you are taking other medications.

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 immediately and seek medical help.

This medication is a nonsteroidal anti-inflammatory drug (NSAID) and may 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. If you notice signs of stomach bleeding—such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain—stop using ibuprofen and contact your doctor. Additionally, if your pain worsens or lasts more than 10 days, or if you have a fever that lasts more than 3 days, seek medical advice.

In case of an overdose, it is crucial to get emergency medical help or contact a Poison Control center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. During the last three months of pregnancy, you should avoid ibuprofen unless your doctor specifically advises you to take it, as it can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking professional 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 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 enough to relieve pain or fever, you may give 2 tablets, but be careful not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

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

Before starting any new medication, it's wise to consult with your doctor, especially if any of these warnings apply to you. Your healthcare provider can help ensure that the medication is safe and appropriate for your specific health needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that certain medications can interact with each other, which may affect how well they work or increase the risk of side effects. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for heart attack or stroke prevention. Additionally, combining ibuprofen with blood thinners (medications that help prevent blood clots) or steroids can raise the risk of stomach bleeding. This risk is even greater if you are also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

To ensure your safety and the effectiveness of your medications, always discuss any current medications or supplements with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan as needed.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25 degrees Celsius (68-77 degrees Fahrenheit). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check that the seal under the bottle cap is intact. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness. Always prioritize these storage and handling guidelines to ensure your safety and the product's reliability.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it 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, menstrual cramps, and to reduce fever.

How should I take Ibuprofen?

Adults and children 12 years and older 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 associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin, and it can increase the risk of stomach bleeding, particularly in older adults or those with certain medical conditions.

Can I take Ibuprofen if I am pregnant or breastfeeding?

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

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 help immediately.

What should I avoid while taking Ibuprofen?

Avoid taking Ibuprofen if you have had an allergic reaction to other pain relievers, if you are about to have heart surgery, or if you are taking blood thinners or other NSAIDs.

How should I store Ibuprofen?

Store Ibuprofen between 20-25 degrees Celsius (68-77 degrees Fahrenheit) and do not use it if the seal under the bottle cap is broken or missing.

Packaging Info

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

Packaging configurations for Clear Choice Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Clear Choice Ibuprofen is a modern pain medicine formulated for the relief of pain and fever. Each tablet contains 200 mg of ibuprofen and is caffeine-free. This product is available in a bottle containing 100 tablets and does not contain aspirin. It is important to note that this product is not manufactured or distributed by Wyeth Consumer Healthcare, the owner of the registered trademark Advil®. Clear Choice Ibuprofen is manufactured for A.N.I. in Toledo, OH 43623, under code 27541.

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

Patients should adhere strictly to the prescribed dosage and administration guidelines. The smallest effective dose should be utilized, and treatment should not exceed 10 days unless otherwise directed by a healthcare professional.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be administered. However, the total daily dosage must not exceed 6 tablets within a 24-hour period unless specifically instructed by a physician.

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 other pain relievers or fever reducers. Additionally, the product should not be administered 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 such reactions include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Should any signs of an allergic reaction manifest, 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 concurrently using blood-thinning medications (anticoagulants) or steroids, 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.

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. 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 affected area, or if any new symptoms arise.

In the event of an overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control center at 1-800-222-1222 for guidance.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

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

Additionally, ibuprofen carries a warning regarding the risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning medications or steroids, and those consuming three or more alcoholic drinks daily while using this product. Patients who take ibuprofen for longer than directed or in higher doses may also be at increased risk.

Clinical trial data and postmarketing experiences indicate that patients should 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 experiencing persistent stomach pain. Furthermore, patients are advised to seek medical attention if their pain worsens or lasts more than 10 days, if fever persists beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma or those taking diuretics should also seek medical advice prior to use. It is important for patients taking aspirin for cardiovascular protection to be aware that ibuprofen may diminish the effectiveness of aspirin in preventing heart attacks or strokes. Additionally, individuals under a doctor's care for any serious condition or those taking other medications should consult a healthcare professional before using ibuprofen.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attacks or strokes. Therefore, concurrent use of these medications should be approached with caution, particularly in patients relying on aspirin for cardiovascular protection.

The concomitant use of ibuprofen with anticoagulants or corticosteroids may elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider appropriate dosage adjustments or alternative therapies as necessary.

Additionally, the risk of gastrointestinal bleeding is further increased when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. It is advisable to avoid the simultaneous use of multiple NSAIDs to mitigate this risk.

Packaging & NDC

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

Packaging configurations for Clear Choice 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 in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding. It is advisable for these patients to consult a healthcare provider prior to using this medication, especially if they have a history of stomach issues, such as heartburn.

Additionally, geriatric patients with pre-existing conditions, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, should exercise caution. These conditions may necessitate careful monitoring and potential dosage adjustments to ensure safety and efficacy.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is especially important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available 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 while breastfeeding.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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. Patients should be informed that taking the medication with food or milk may help alleviate any stomach upset that occurs.

It is important to discuss the potential risks associated with the medication, including an increased risk of heart attack or stroke if the patient uses more than the directed dosage or for a longer duration than recommended. Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients should also be advised to discontinue use and seek medical advice if their pain worsens or lasts longer than 10 days, if their fever worsens or persists for more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should be advised to seek medical guidance prior to use.

Patients taking diuretics or those under a doctor's care for any serious condition should also be encouraged to consult a healthcare professional before using the medication. Furthermore, it is essential to inform patients that they should speak with a doctor or pharmacist if they are taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Lastly, patients should be reminded to consult a healthcare professional if they are taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the seal under the bottle cap is broken or missing, as this may compromise the product's safety and effectiveness. Proper handling and storage conditions are essential to ensure the quality of the product throughout its shelf life.

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 three months 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 Clear Choice 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 Clear Choice 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.