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Aerotab Ibuprofen

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Active ingredient
Ibuprofen 200 mg/1000 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2018
Label revision date
February 26, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg/1000 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2018
Label revision date
February 26, 2025
Manufacturer
Aero Healthcare
Registration number
ANDA091239
NDC root
55305-133
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Ibuprofen is a medication that belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is commonly used to temporarily relieve minor aches and pains, such as those caused by headaches, toothaches, backaches, menstrual cramps, muscular aches, and even minor arthritis pain. Additionally, ibuprofen is effective in reducing fever, making it a versatile option for managing discomfort and illness.

The way ibuprofen works is by reducing inflammation in the body, which helps alleviate pain and lower fever. Whether you're dealing with a common cold or everyday aches, ibuprofen can provide relief and help you feel more comfortable.

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 pain associated with arthritis. It can also help ease discomfort from the common cold. Additionally, this medication is effective in temporarily reducing fever.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

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, it’s best to consult a doctor before giving them this medication. Always follow the doctor’s instructions and use the smallest effective dose to ensure safety. Remember, taking more than the recommended amount can lead to serious health risks, so it’s crucial to adhere to the guidelines provided.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication as outlined in the provided information. Additionally, there are no explicit instructions regarding situations in which you should not take or use this medication.

If you have any concerns or questions about your health or medication, it's always best to consult with your healthcare provider for personalized advice.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

Additionally, ibuprofen carries risks of stomach bleeding, particularly for individuals over 60, those with a history of stomach ulcers or bleeding, and those taking certain medications like blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for extended periods. If you notice signs of stomach bleeding (such as feeling faint, vomiting blood, or having black stools) or symptoms of heart problems (like chest pain or trouble breathing), stop using ibuprofen and consult a doctor right away. Always talk to your doctor before using ibuprofen if you have any underlying health conditions or are taking other medications.

Warnings and Precautions

You should be aware that ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (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 it for longer than recommended. Additionally, ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should stop using ibuprofen and contact your doctor if you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms include chest pain, trouble breathing, weakness on one side of the body, slurred speech, or swelling in the legs. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center (1-800-222-1222) right away, even if no symptoms are present.

Overdose

Taking too much ibuprofen can be very harmful. If you or someone you know has taken an overdose, you might notice symptoms such as nausea (feeling sick), vomiting, stomach pain, dizziness, and drowsiness. In more serious situations, an overdose can lead to kidney failure, liver damage, and gastrointestinal bleeding (bleeding in the stomach or intestines).

If you suspect an overdose, it’s crucial to seek immediate medical attention. Don’t wait for symptoms to worsen; getting help quickly can make a significant difference in the outcome. Always remember that it’s better to be safe and consult a healthcare professional if you have any concerns about medication use.

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 prioritize your health and the health of your baby by seeking guidance from your doctor.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using 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 pose risks to your unborn child or lead to complications during delivery. Always prioritize your health and the health of your baby by seeking professional guidance.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before giving them this medication. For children aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you can give 2 tablets, but make sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise.

Always use the smallest effective dose for children to minimize risks. Be aware that if an overdose occurs, it's crucial to seek medical help immediately, even if there are no noticeable symptoms. Your child's safety is the top priority, so don't hesitate to reach out to a healthcare professional with any questions or concerns.

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, you have a higher chance of experiencing severe stomach bleeding. This risk is particularly significant if you take medications that can irritate the stomach lining. Additionally, using these medications in higher doses or for longer than recommended can increase your risk of heart attack and stroke.

To stay safe, always follow your healthcare provider's instructions regarding dosage and duration of any medication. If you have concerns about your medications or their effects, don’t hesitate to discuss them with your doctor or pharmacist. Your health and safety are the top priority.

Renal Impairment

If you have kidney issues, 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 for the medication do not change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to adjust your treatment plan based on your overall condition and any other medications you may be taking.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help monitor your liver function and make any necessary adjustments to your care.

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 are taking aspirin to prevent a heart attack or stroke, using ibuprofen at the same time may reduce the benefits of aspirin. Additionally, ibuprofen can interact with blood thinners (medications that help prevent blood clots), potentially increasing the risk of stomach bleeding. This risk is even higher if you are also taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

To ensure your safety and the effectiveness of your medications, always consult your doctor or pharmacist before starting any new medication, especially if you are already taking other drugs. They can help you navigate these interactions and make informed decisions about your health.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check the packaging carefully. It should be tamper evident, meaning you should not use it if the packet is torn, cut, or opened, as this could compromise its safety and effectiveness. Always prioritize these guidelines to ensure safe usage.

Additional Information

No further information is available.

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 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.

What should children under 12 do before taking Ibuprofen?

Children under 12 years should ask a doctor before use and should not take more than directed.

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

Stop use and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not get better.

Are there any warnings associated with taking Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke, especially if used more than directed or for longer than directed.

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.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

How should I store Ibuprofen?

Store Ibuprofen between 20°C to 25°C (68°F to 77°F) and do not use if the packet is torn, cut, or opened.

Packaging Info

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

Packaging configurations for Aerotab Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

AeroTab is a pharmaceutical formulation containing Ibuprofen USP at a dosage strength of 200 mg per tablet. It is classified as an anti-inflammatory agent, serving as both a fever reducer and pain reliever. Each box contains 50 tablets, with packets containing 2 tablets each, totaling 250 tablets per box.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothaches, 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

Adults and children 12 years of age 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, it is recommended to consult a doctor prior to administration. Care should be taken to adhere to the prescribed dosage, ensuring that the smallest effective dose is utilized to minimize the risk of overdose.

Contraindications

There are no contraindications explicitly stated for this product. It is important to evaluate individual patient circumstances and clinical judgment when considering its use.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can 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.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

  • Are aged 60 years or older

  • Have a history of stomach ulcers or bleeding disorders

  • Are concurrently using anticoagulants or steroid medications

  • Are taking other NSAIDs, including prescription medications such as aspirin, ibuprofen, or naproxen

  • Consume three or more alcoholic beverages daily while using this product

  • Exceed the recommended dosage or duration of use

Healthcare professionals should monitor patients for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is 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 treatment.

Signs to Discontinue Use and Consult a Doctor Patients should be advised to stop using ibuprofen and consult a healthcare provider if they experience any of the following symptoms:

  • Faintness

  • Vomiting blood

  • Bloody or black stools

  • Persistent stomach pain

  • Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling

  • Worsening pain lasting more than 10 days

  • Fever that worsens or persists beyond three days

  • Redness or swelling in the affected area

  • Any new or unusual symptoms

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no signs or symptoms are apparent. Prompt intervention is essential for both adults and children.

Side Effects

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

Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. In the event of an allergic reaction, patients are advised to discontinue use and seek immediate medical assistance. Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding, particularly 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 exceeding the recommended dose or duration.

Common adverse reactions may include gastrointestinal symptoms, and patients should be vigilant for signs of stomach bleeding, which necessitate immediate medical consultation. These signs include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain. Patients should also seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, leg swelling, or if pain worsens or lasts longer than 10 days. Furthermore, if fever persists or worsens beyond three days, or if redness or swelling occurs in the painful area, medical attention should be sought.

Before using ibuprofen, patients are advised to consult a healthcare professional if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking diuretics. It is also recommended to discuss use with a doctor if the patient is under care for any serious condition or is taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in this context.

Drug Interactions

Taking aspirin for the prevention of heart attack or stroke may diminish the therapeutic effects of aspirin when administered concurrently with ibuprofen. This interaction suggests that patients should be cautious when using these medications together, as the intended benefits of aspirin may not be fully realized.

Ibuprofen has the potential to interact with anticoagulant medications, which may elevate the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is used in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription medications such as aspirin and naproxen.

Given these interactions, it is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating ibuprofen if they are currently taking any other medications. Monitoring for signs of gastrointestinal bleeding may also be warranted in patients using these combinations.

Packaging & NDC

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

Packaging configurations for Aerotab Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered; however, the total dosage must not exceed 6 tablets within a 24-hour period unless otherwise directed by a physician.

It is important to utilize the smallest effective dose for pediatric patients. Additionally, an overdose warning is applicable; prompt medical attention is essential for both children and adults, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications. Healthcare providers should closely monitor these patients for any signs of stomach bleeding and consider alternative therapies when appropriate.

Additionally, the risk of heart attack and stroke is significantly elevated in geriatric patients who exceed the recommended dosage or duration of treatment. It is essential for healthcare providers to adhere to prescribed guidelines and to counsel elderly patients on the importance of following dosing instructions to mitigate these risks. Regular assessment and monitoring of cardiovascular health in this population are advised to ensure patient safety.

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 explicitly 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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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

Overdosage of ibuprofen can result in significant health risks. Healthcare professionals should be aware of the potential symptoms and management strategies associated with such incidents.

Symptoms of Overdosage Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, dizziness, and drowsiness. These symptoms can vary in severity depending on the amount ingested and the individual’s health status.

In more severe cases, an overdose can lead to critical complications such as kidney failure, liver damage, and gastrointestinal bleeding. These conditions require immediate medical evaluation and intervention.

Recommended Actions If an overdose is suspected, it is imperative to seek immediate medical attention. Prompt assessment and treatment are essential to mitigate the potential for serious harm. Healthcare providers should be prepared to conduct a thorough evaluation and initiate appropriate management protocols based on the severity of the symptoms and the clinical presentation of the patient.

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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 must be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. It is crucial to emphasize that quick medical attention is necessary for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, they should be aware of symptoms indicating potential heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, leg swelling, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, redness or swelling in the painful area, or the appearance of any new symptoms.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is also important for healthcare providers to recommend that patients consult a doctor before use if they have a history of stomach bleeding, serious side effects from pain relievers or fever reducers, or any stomach problems such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, a history of stroke, or those taking diuretics should also seek medical advice prior to use.

Furthermore, patients should be encouraged to ask a doctor or pharmacist before using this medication if they are under a doctor's care for any serious condition, are taking aspirin for a heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or are taking any other medications.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize the product if the packet is torn, cut, or opened.

For optimal storage, the product should be maintained at a temperature range of 20°C to 25°C (68°F to 77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aerotab 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 Aerotab 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.