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Assured Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
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 2017
Label revision date
December 26, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
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 2017
Label revision date
December 26, 2019
Manufacturer
Spirit Pharmaceutical LLC
Registration number
ANDA079174
NDC root
68210-0081
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

ASSURED™ is a medication that contains ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). 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, ASSURED™ can help reduce fever, making it a versatile option for managing discomfort and illness.

When you take ASSURED™, it works by blocking certain substances in the body that cause pain and inflammation, helping you feel more comfortable during times of discomfort. Whether you're dealing with a common cold or everyday aches, this medication can provide relief to help you get through your day.

Uses

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

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

Dosage and Administration

It's important to follow the dosage instructions carefully when taking this medication. You should not take more than the recommended amount, and it's best to use the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the typical dose is 1 tablet every 4 to 6 hours as needed while symptoms persist. If you find that 1 tablet isn't enough to relieve your pain or fever, you can take 2 tablets instead. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

If you are considering this medication for a child under 12 years old, it's essential to consult a doctor first. Additionally, you should not use this medication for longer than 10 days unless directed by a healthcare professional. Always prioritize your health and safety by following these guidelines closely.

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 heart surgery or have just had one. It's important to stop using the product and consult 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. Additionally, if your pain worsens or lasts more than 10 days, or if your fever lasts more than 3 days, you should seek medical advice.

While using this medication, be aware that taking more than the recommended dose or using it for an extended period can increase your risk of serious issues like heart attack or stroke. Always follow the directions carefully to minimize these risks.

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, 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 ibuprofen, particularly if used in higher doses or for extended periods. If you experience symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, you should stop using ibuprofen and consult a doctor. It's important to talk to your healthcare provider before using ibuprofen if you have any existing health conditions 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, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help. Additionally, this medication is a nonsteroidal anti-inflammatory drug (NSAID) that can 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 directed. NSAIDs, except for aspirin, can also increase the risk of heart attack, heart failure, and stroke, especially with prolonged use.

Before using ibuprofen, consult your doctor if you have ever had an allergic reaction to pain relievers, are scheduled for heart surgery, or have conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also important to talk to your doctor if you are taking aspirin for heart issues, as ibuprofen may reduce its effectiveness. If you experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, stop taking ibuprofen and contact your doctor. Seek emergency medical help or call Poison Control at 1-800-222-1222 if you suspect an overdose.

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.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

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. 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 giving them this medication. For those aged 12 and older, you can administer 1 tablet every 4 to 6 hours as needed while symptoms persist. 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 directed by a healthcare professional. Always prioritize safety and seek guidance if you have any concerns about your child's health.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This risk is particularly significant if you have a history of stomach ulcers or bleeding issues, are taking blood thinners (medications that prevent blood clots), or are using steroids. Additionally, if you are taking other medications that contain NSAIDs (nonsteroidal anti-inflammatory drugs), drinking three or more alcoholic beverages daily, or using this product for longer than recommended, your chances of experiencing stomach bleeding may rise.

To help protect your health, make sure to discuss your complete medication list with your healthcare provider, especially if you fall into these categories. They can guide you on safe usage and help you manage any potential risks effectively.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any existing conditions, including high blood pressure, heart disease, liver cirrhosis, or asthma, as these can affect how the medication works in your body.

Always prioritize your health by discussing any concerns with your doctor to ensure safe and effective treatment tailored to your needs.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it’s important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition closely to ensure your safety.

Always inform your doctor about any other health issues you may have, including high blood pressure, heart disease, kidney disease, or asthma, as these can also affect your treatment plan. 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 talk to your healthcare provider about any medications you are taking, including ibuprofen. If you are using ibuprofen along with aspirin for heart protection, be aware that ibuprofen may reduce the effectiveness of aspirin. Additionally, if you are on blood thinners (medications that prevent blood clots) or steroids, using ibuprofen can increase your risk of stomach bleeding.

Also, using ibuprofen for longer than recommended or in higher doses can raise your chances of having a heart attack or stroke. Always consult with your healthcare provider to ensure that your medications are safe to use together and to discuss any potential risks.

Storage and Handling

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

Before using the product, make sure to read all warnings and directions carefully. Keeping the carton is also recommended, as it contains important information that may be useful for future reference. By following these guidelines, you can help ensure safe handling and optimal use of the product.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult 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 ASSURED™?

ASSURED™ is a pain reliever and fever reducer that contains ibuprofen, similar to the active ingredient in ADVIL® TABLETS.

What conditions does ASSURED™ temporarily relieve?

ASSURED™ temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis. It also temporarily reduces fever.

What is the recommended dosage 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.

What should I do if I experience stomach bleeding symptoms?

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

Are there any warnings associated with ASSURED™?

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

Can I use ASSURED™ if I am pregnant or breastfeeding?

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

What should I do if I have a history of allergic reactions to pain relievers?

Do not use ASSURED™ if you have ever had an allergic reaction to any other pain reliever or fever reducer.

How should I store ASSURED™?

Store ASSURED™ 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 Assured Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Assured Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ASSURED™ Ibuprofen Tablets USP contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each bottle contains a total of 60 tablets, with an additional bonus of 40 tablets, providing a total of 100 tablets per package. The tablets are designed for oral administration and are comparable to the active ingredient found in Advil® Tablets.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and 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 directed by a physician.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

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 any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, stomach discomfort increases or remains, redness or swelling occurs in the affected area, or any new symptoms arise, medical advice should be sought.

Caution is advised as the risk of heart attack or stroke may increase with use beyond the recommended dosage or duration.

Warnings and Precautions

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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries the 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 thinners (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. Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended guidelines.

General precautions should be observed prior to the use of ibuprofen. It is contraindicated in individuals with a history of allergic reactions to any pain reliever or fever reducer. Furthermore, it should not be administered immediately before or after heart surgery. Healthcare professionals should be consulted before use if the patient has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, suffers from gastrointestinal issues such as heartburn, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or is taking a diuretic. Additionally, patients under a physician's care for serious conditions or those taking aspirin for cardiovascular protection should seek advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

In the event of an overdose, immediate medical attention is required, and contacting a Poison Control Center (1-800-222-1222) is advised.

Patients should discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to stop use include worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, exacerbation of stomach discomfort, the presence of redness or swelling in the painful area, or the emergence of any new symptoms.

Side Effects

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

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

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. This risk 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 while using the product, or exceed the recommended dosage or duration of use.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in higher doses or for extended periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to seek medical advice include worsening pain lasting more than 10 days, fever lasting more than 3 days, worsening stomach upset, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach bleeding, serious side effects from pain relievers or fever reducers, stomach problems like heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also important to inform a healthcare provider if the patient is taking a diuretic or is under care for any serious condition. Furthermore, patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may interact with several medications, leading to significant clinical effects that warrant careful consideration.

Interactions with Aspirin Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are used concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin for this purpose to ensure optimal therapeutic outcomes.

Interactions with Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

Prolonged Use Risks Extended use of ibuprofen, particularly at doses exceeding the recommended guidelines, may elevate the risk of cardiovascular events, including heart attack and stroke. It is essential to adhere to prescribed dosages and duration of therapy to minimize these risks. Regular assessment of the patient's cardiovascular status is recommended during prolonged ibuprofen therapy.

Packaging & NDC

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

Packaging configurations for Assured Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets in 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 of severe stomach bleeding. This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems. Caution is advised for geriatric patients who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, as well as those taking other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription.

Additionally, the risk of stomach bleeding is amplified in elderly patients who consume three or more alcoholic drinks daily while using this product. It is essential for healthcare providers to monitor these patients closely and consider dose modifications or alternative therapies as necessary to mitigate these risks.

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. It is particularly important to avoid the use of 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. 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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or asthma. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of kidney disease.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing potential overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve activated charcoal administration, intravenous fluids, or other interventions based on the clinical presentation.

It is vital for healthcare professionals to remain vigilant and prepared to address any complications that may arise from an overdose, ensuring the best possible outcomes for affected individuals.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No additional non-teratogenic effects or specific nonclinical toxicology details have been identified in the available data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have documented gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported.

Additionally, there have been cases of cardiovascular events, such as heart attack and stroke, linked to ibuprofen use. Some patients have experienced allergic reactions, including anaphylaxis and angioedema. Elevated blood pressure has been noted in certain patients using ibuprofen. Furthermore, instances of gastrointestinal perforation have been observed, particularly in individuals with a history of ulcers or those concurrently using other nonsteroidal anti-inflammatory drugs (NSAIDs).

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients must be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Patients should be instructed to stop using the medication 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. They should also seek medical advice if their pain worsens or lasts longer than 10 days, if their fever worsens or lasts more than 3 days, or if stomach pain or upset persists or worsens. Furthermore, patients should stop use and consult a doctor if there is any redness or swelling in the painful area or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is important to communicate that the risk of heart attack or stroke may increase if the medication is used in higher doses or for longer than recommended.

Patients should be encouraged to ask a doctor before use if the warning regarding stomach bleeding applies to them, or if they have experienced problems or serious side effects from taking pain relievers or fever reducers. They should also consult a doctor if they have stomach issues, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking a diuretic should seek medical advice before using this medication.

Patients should be reminded to consult a doctor or pharmacist before use if they are under a doctor's care for any serious condition, or if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients should be advised to consult a doctor or pharmacist before using this medication if they are taking any other drugs.

Storage and Handling

The product is supplied in a carton that should be retained for reference. It is essential to store the product at a temperature range of 20°-25°C (68°-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Prior to use, healthcare professionals are advised to read all warnings and directions provided.

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 Assured 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 Assured 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.