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Henry Schein 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 2015
Label revision date
September 8, 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 2015
Label revision date
September 8, 2025
Manufacturer
Henry Schein Inc.
Registration number
ANDA075010
NDC root
0404-0017
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Ibuprofen is a medication commonly used for the temporary relief of minor aches and pains, including headaches, toothaches, backaches, menstrual cramps, and muscular aches. It is also effective in reducing fever. As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen works by blocking certain substances in the body that cause inflammation and pain, helping you feel more comfortable during times of discomfort.

Uses

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

In addition to pain relief, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well.

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 otherwise.

For children under 12 years of age, this medication is not recommended, so please do not give it to them. Always follow the guidance of a healthcare professional for the best results and safety.

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, or if you are about to undergo or have just had heart surgery. It's important to be aware of potential serious side effects. If you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, stop using the medication and consult your doctor immediately.

Additionally, seek medical attention if you experience symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of your body, slurred speech, or swelling in your legs. You should also stop using the medication if your pain worsens or lasts longer than 10 days, if your fever worsens or lasts more than 3 days, if you see redness or swelling in the painful area, or if you develop any new or unexpected symptoms.

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, skin reddening, asthma (wheezing), facial swelling, rash, shock, 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, heart failure, and stroke associated with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods. If you experience symptoms such as fainting, vomiting blood, black or bloody stools, chest pain, trouble breathing, 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, high blood pressure, 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 hives, skin reddening, asthma (wheezing), facial swelling, rash, 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 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 or stroke, which can be fatal.

You should get emergency medical help if you suspect an overdose. Stop using ibuprofen and contact 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), or if your pain or fever worsens or lasts longer than expected.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when in doubt, it’s better to err on the side of caution and seek assistance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always 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 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 may 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 healthcare provider regarding any medications you may consider while breastfeeding.

Pediatric Use

It's important to be cautious when giving medication to children. You should not give this medication to children under 12 years of age. For those who are 12 years 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, but be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always consult with a healthcare professional if you have any questions or concerns 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 years or older, there is a higher chance of experiencing severe stomach bleeding. To help minimize this risk, it is recommended that you take the smallest effective dose of your medication and avoid using it for longer than directed.

Always consult with your healthcare provider about the best approach for your specific needs, especially if you are managing multiple medications or have other health concerns. Your safety and well-being are the top priority.

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 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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

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

When handling the product, make sure to use only tamper-evident sealed packets. If you notice any packets that are opened or torn, do not use them, as this could pose a safety risk. Following these guidelines will help you maintain the integrity of the product and ensure safe usage.

Additional Information

No further information is available.

FAQ

What is Ibuprofen used for?

Ibuprofen is used for temporary relief of minor aches and pains associated with headaches, toothaches, backaches, menstrual cramps, muscular aches, minor arthritis pain, and for the reduction of fever.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years and older 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.

Can children under 12 years take Ibuprofen?

No, Ibuprofen should not be given to children under 12 years of age.

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

Stop using Ibuprofen and ask a doctor if you experience symptoms like feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not get better.

What are the allergy alerts for Ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms can include hives, skin reddening, asthma, facial swelling, rash, shock, and blisters.

Is there a risk of heart attack or stroke with Ibuprofen?

Yes, NSAIDs like Ibuprofen increase the risk of heart attack, heart failure, and stroke, especially if used more than directed or for longer than directed.

What should I do if I overdose on Ibuprofen?

In case of overdose, get medical help or contact a Poison Control Center right away.

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 during the last 3 months of pregnancy unless directed by a doctor.

How should I store Ibuprofen?

Store Ibuprofen at 68-77°F (20-25°C) and avoid excessive heat above 40°C (104°F).

Packaging Info

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

Packaging configurations for Henry Schein Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Henry Schein 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, the common cold, toothache, muscular aches, backache, menstrual cramps, 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

Adults and children aged 12 years and older 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, this medication is contraindicated and should not be administered.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications.

Patients should discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

Further contraindications include worsening pain lasting more than 10 days, fever persisting beyond 3 days, presence of redness or swelling in the affected area, or the emergence of any new or unexpected symptoms.

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, skin reddening, asthma (wheezing), facial swelling, rash, 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 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 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, with the exception of aspirin, are known to elevate the 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 extended periods.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help 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, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts longer than 3 days, if there is redness or swelling in the affected area, or if any new or unexpected symptoms arise. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this serious adverse reaction is heightened 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 use other NSAIDs concurrently.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who exceed the recommended dosage or duration of use.

Common adverse reactions may include gastrointestinal symptoms, 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, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

Patients should seek medical advice if pain persists beyond 10 days, fever worsens or lasts more than three days, redness or swelling occurs in the affected area, or any new or unexpected symptoms arise.

Before using this product, patients with a history of serious side effects from pain relievers or fever reducers, those with stomach bleeding concerns, or individuals with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should consult a healthcare provider. It is also recommended that patients taking aspirin for cardiovascular protection discuss their use of ibuprofen with a doctor, as it may diminish the cardioprotective effects of aspirin.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Henry Schein Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Henry Schein Ibuprofen.
Details

Pediatric Use

Children under 12 years of age should not be administered this medication. For pediatric patients aged 12 years and older, the recommended dosage is 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, 2 tablets may be taken. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. Therefore, it is crucial for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

To minimize the risk of adverse effects, it is recommended that the smallest effective dose be administered, and the duration of use should not exceed the directed limits. Close monitoring of these patients is advised to ensure safety and efficacy while managing their treatment.

Pregnancy

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

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

There is no specific information available 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 these patients to ensure safety and efficacy.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial for healthcare professionals to document all findings and interventions thoroughly and to report any adverse events or overdose cases to the appropriate regulatory authorities as per local guidelines.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically 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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has indicated that several adverse reactions have been reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes.

Additional adverse reactions noted encompass allergic reactions, such as anaphylaxis, as well as skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. Reports of cardiovascular events, including heart attack and stroke, have also been associated with the use of NSAIDs, including ibuprofen. Furthermore, cases of hypertension have been documented in patients taking ibuprofen.

Serious skin reactions, such as exfoliative dermatitis and erythema multiforme, have been reported. Additionally, some patients have experienced a worsening of asthma symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is important to inform patients that they should not use this product right before or after undergoing heart surgery.

Healthcare providers should instruct patients 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 seek medical attention if they exhibit symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Patients should be informed to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts longer than 3 days, if there is redness or swelling in the painful area, or if any new or unexpected symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. Healthcare providers should encourage patients to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past, or if the warning regarding stomach bleeding applies to them.

Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to seek medical advice before using this medication. Additionally, patients with asthma or those taking diuretics should consult a doctor prior to use.

Healthcare providers should also recommend that patients taking aspirin for heart attack or stroke consult a doctor or pharmacist before using this medication, as ibuprofen may diminish the cardiovascular benefits of aspirin. Finally, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to discuss their use of this product with their healthcare provider or pharmacist.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at a temperature range of 68-77°F (20-25°C). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Opened or torn packets must not be used to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Henry Schein 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 Henry Schein 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.