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Ibuprofen

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Active ingredient
Ibuprofen 200 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 2014
Label revision date
December 6, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 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 2014
Label revision date
December 6, 2024
Manufacturer
AAA Pharmaceutical, Inc.
Registration number
ANDA079129
NDC root
57344-110
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

RESTORE u is a medication that contains ibuprofen, which is a type of pain reliever and fever reducer classified as a nonsteroidal anti-inflammatory drug (NSAID). It comes in the form of coated tablets, each containing 200 mg of ibuprofen. You can use RESTORE u to temporarily relieve minor aches and pains caused by various conditions, including headaches, backaches, toothaches, menstrual cramps, and muscular aches. Additionally, it can help reduce fever.

This medication is similar to the active ingredient found in Advil®, making it a familiar option for those seeking relief from discomfort. Whether you're dealing with the common cold or minor arthritis pain, RESTORE u can provide the support you need to feel better.

Uses

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

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

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

For children under 12 years of age, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

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

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, skin reddening, and difficulty breathing (asthma). Additionally, ibuprofen is an NSAID (nonsteroidal anti-inflammatory drug) that can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or other NSAIDs.

If you experience symptoms such as feeling faint, vomiting blood, or having black or bloody stools, you should stop using ibuprofen and consult a doctor immediately. It's also important to seek medical advice if your pain worsens or lasts longer than 10 days, or if you develop new symptoms. Always talk to your doctor 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, or difficulty breathing. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help. Additionally, ibuprofen can lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers, or are taking blood thinners or other NSAIDs. It's important to avoid using ibuprofen if you have had an allergic reaction to pain relievers or if you are about to undergo heart surgery.

Before using ibuprofen, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. If you are taking aspirin for heart conditions, be aware that ibuprofen may reduce its effectiveness. While using this medication, take it with food or milk to minimize stomach upset, and do not exceed the recommended dosage, as this can increase the risk of heart attack or stroke.

If you notice any side effects, such as feeling faint, vomiting blood, or having bloody stools, stop using ibuprofen and contact your doctor. Also, seek medical help if your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days. In case of an overdose, get medical assistance or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t wait for symptoms to appear. Getting prompt assistance can be vital for safety and recovery.

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 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.

Lactation Use

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

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, they can take one caplet every 4 to 6 hours as needed for symptoms. If one caplet doesn't relieve pain or fever, they may take two caplets instead. However, make sure they do not exceed six caplets in a 24-hour period unless a doctor has given specific instructions to do so. Always prioritize safety and follow these guidelines to ensure your child's well-being.

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 means that if you or a loved one falls into this age group, extra caution should be taken when using certain medications, especially those that can irritate the stomach.

Always consult with your healthcare provider about the safest options for you, and make sure to discuss any medications you are taking to minimize potential risks. Your health and safety are paramount, so staying informed and proactive is key.

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 follow your doctor's advice regarding dosage and monitoring, especially if you have renal impairment (kidney issues). This ensures that you use the medication safely and effectively while managing your health conditions.

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 more closely. This is crucial to ensure your safety and the effectiveness of the treatment. Always keep your doctor informed about any existing health issues, including high blood pressure, heart disease, kidney disease, or asthma, as these can also affect your treatment plan.

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications and affect your health. For instance, if you take ibuprofen along with aspirin for heart protection, it may reduce the effectiveness of aspirin. Additionally, using ibuprofen while on blood thinners (medications that prevent blood clots) or steroids can increase your risk of stomach bleeding.

Moreover, using ibuprofen for longer than recommended or in higher doses can raise your chances of experiencing a heart attack or stroke. Always discuss any medications you are taking, including over-the-counter drugs like ibuprofen, with your healthcare provider to ensure your safety and well-being.

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°-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 compromise its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is RESTORE u?

RESTORE u is a pain reliever and fever reducer that contains ibuprofen as its active ingredient.

What are the indications for using RESTORE u?

RESTORE u temporarily relieves minor aches and pains due to headaches, backaches, the common cold, minor arthritis pain, toothaches, menstrual cramps, and muscular aches, and it also temporarily reduces fever.

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

You should take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, you may use 2 caplets, but do not exceed 6 caplets in 24 hours unless directed by a doctor.

What should I do if I experience side effects?

If side effects occur, stop use and ask a doctor. You may report side effects to the FDA at 1-800-FDA-1088.

Are there any contraindications for using RESTORE u?

Do not use RESTORE u if you have ever had an allergic reaction to any other pain reliever or fever reducer, or if you are using it right before or after heart surgery.

What should I do 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 are the potential risks of using RESTORE u?

Using RESTORE u may increase the risk of heart attack or stroke if used more than directed or for longer than directed. It may also cause severe stomach bleeding, especially in certain populations.

What should I do if I have a history of stomach problems?

Ask a doctor before using RESTORE u if you have a history of stomach problems, such as ulcers or bleeding, or if you are taking blood thinners or other NSAIDs.

How should I store RESTORE u?

Store RESTORE u 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 Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

RESTORE u is a nonsteroidal anti-inflammatory drug (NSAID) containing Ibuprofen as its active ingredient. Each tablet is formulated as a coated caplet, with a strength of 200 mg. The product is available in a package containing 100 coated caplets. RESTORE u is indicated for the relief of pain and reduction of fever. The National Drug Code (NDC) for this formulation is 57344-110-03.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets 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 for appropriate dosing guidance.

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 associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction can include hives, shock, facial swelling, skin reddening, asthma (wheezing), rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of experiencing 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.

Ibuprofen should not be used in individuals with a prior allergic reaction to any other pain reliever or fever reducer, nor should it be administered immediately before or after heart surgery.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if the patient is taking a diuretic.

Patients should also be counseled to seek guidance from a healthcare provider or pharmacist if they are under medical care for any serious condition, are taking aspirin for cardiovascular protection, or are using any other medications.

When administering this product, it is recommended to take it with food or milk to mitigate potential stomach upset. It is important to note that the risk of heart attack or stroke may increase with the use of higher than directed doses or prolonged use.

Patients should discontinue use and consult a physician if they experience any side effects. Signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, warrant immediate medical attention. Additionally, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise, medical advice should be sought.

In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

Side Effects

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

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the 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.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise, medical advice should be sought.

It is recommended that patients consult a healthcare provider prior to using ibuprofen if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Patients should also inform their healthcare provider if they are taking diuretics or are under medical care for any serious condition. Caution is advised for those taking aspirin for cardiovascular protection, as ibuprofen may diminish the antiplatelet effect of aspirin.

Patients are encouraged to report any side effects to the FDA at 1-800-FDA-1088.

Drug Interactions

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

Interactions with Antiplatelet Agents 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 these indications to ensure optimal therapeutic outcomes.

Interactions with Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or corticosteroids increases the risk of gastrointestinal bleeding. Clinicians should exercise caution when prescribing ibuprofen to patients on these medications and consider monitoring for signs of gastrointestinal complications. Dose adjustments may be necessary based on the individual patient's risk factors.

Prolonged Use Considerations 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 mitigate 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 Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For children aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential when treating this population to ensure optimal safety and efficacy.

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 explicitly directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

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 patient's overall health status and the severity of their kidney disease.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential to assess liver function and consider potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this patient population. Adjustments to dosage or treatment regimens may be necessary 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure 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 definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Side effects may occur, and individuals are encouraged to report any adverse reactions to the FDA at 1-800-FDA-1088.

In cases of potential stomach bleeding, it is advised to discontinue use and consult a healthcare professional if any of the following symptoms occur: feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or persists for more than 10 days. Additionally, if fever intensifies or lasts more than 3 days, if redness or swelling is observed in the painful area, or if any new symptoms arise, medical advice should be sought.

Patient Counseling

Healthcare providers should advise patients to keep the 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 informed to take the medication with food or milk if they experience stomach upset. It is important to communicate that using more than the directed dose or using the medication for longer than recommended may increase the risk of heart attack or stroke.

Healthcare providers should make patients aware that side effects may occur and encourage them to report any adverse effects to the FDA at 1-800-FDA-1088. Patients should be instructed to seek medical attention if they experience any signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Patients should also be advised to consult a healthcare professional if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms appear.

Before using the medication, patients should be encouraged to ask a doctor if the stomach bleeding warning applies to them, especially if they have a history of stomach problems such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking a diuretic should consult a healthcare provider prior to use.

Patients should also be advised to consult a doctor or pharmacist before using the medication if they are under a doctor's care for any serious condition, if they are taking aspirin for heart attack or stroke (as ibuprofen may decrease the benefit of aspirin), or if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature between 20°-25°C (68°-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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 trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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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.