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Fast Pain Relief

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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 2011
Label revision date
June 5, 2017
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 2011
Label revision date
June 5, 2017
Manufacturer
HealthLife of USA LLC
Registration number
ANDA079174
NDC root
69517-111
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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

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

Drug Overview

Ibuprofen is a medication 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 headaches, toothaches, backaches, menstrual cramps, muscular aches, and pain associated with the common cold. Additionally, ibuprofen can help reduce fever.

This specific formulation contains 200 mg of ibuprofen, which is similar to the active ingredient found in Advil®. It is important to note that this product is not manufactured or distributed by Pfizer Healthcare, the owner of the Advil® trademark.

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 ease 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 doesn't cause birth defects) associated with this medication.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should not take more than the directed amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended 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, be cautious not to exceed 6 tablets in a 24-hour period unless your doctor has advised you otherwise. If you have a child under 12 years old, it's essential to consult a doctor before giving them this medication. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

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 follow the recommended dosage closely, as using more than directed or for a longer period can increase your risk of serious issues like heart attack or stroke.

Additionally, be aware that there are concerns regarding the potential for dependence (a condition where your body becomes reliant on a substance). Always consult with your healthcare provider if you have any questions or concerns about using this medication safely.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers or bleeding, or who consume alcohol regularly. If you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools, you should stop using ibuprofen and consult a doctor immediately.

It's important to avoid 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. Pregnant or breastfeeding individuals should also seek medical advice before use, particularly during the last three months of pregnancy, as it may pose risks to the unborn child or complications during delivery.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately. 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.

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. It's also important to talk to your doctor if you are taking aspirin for heart conditions, as ibuprofen may reduce its effectiveness. If you suspect an overdose, seek medical help or contact a Poison Control Center right away. Stop taking ibuprofen and call your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or if your pain or fever worsens or lasts longer than expected.

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 what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure you can respond promptly if needed.

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 for symptoms. If one tablet isn't enough to relieve pain or fever, you may give 2 tablets. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate dosage for your child.

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 that can affect the stomach. Always consult with your healthcare provider about the safest options for you, especially if you have any existing health conditions or are taking other medications. Your safety and well-being are the top priority, so don't hesitate to ask questions and discuss any concerns you may have.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or asthma. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or monitor your liver function closely. This is to ensure that the medication is safe and effective for you, as liver impairment can change how your body processes certain drugs.

Always communicate openly with your doctor about your liver condition and any other health issues you may have, such as high blood pressure, heart disease, kidney disease, or asthma. This information is crucial for your safety and the effectiveness of your treatment plan.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take aspirin to prevent heart attacks or strokes, using it alongside ibuprofen may reduce the effectiveness of aspirin. Additionally, ibuprofen can increase the risk of severe stomach bleeding, particularly if you are also taking blood-thinning medications or steroids.

Moreover, using ibuprofen for longer than recommended 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 the effectiveness of your treatment.

Storage and Handling

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

When handling the product, always check the safety seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

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 Ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain.

How should I take Ibuprofen?

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist. Do not exceed 6 tablets in 24 hours unless directed by a doctor.

What should I do if I experience stomach upset while taking Ibuprofen?

If you experience stomach upset, take Ibuprofen with food or milk.

Are there any warnings associated with Ibuprofen?

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

Can I take Ibuprofen if I am pregnant or breastfeeding?

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

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

Stop using Ibuprofen and contact your doctor if you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools.

Who should not use Ibuprofen?

Do not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever/fever reducer or if you are about to have heart surgery.

What is the risk of heart attack or stroke with Ibuprofen?

The risk of heart attack or stroke may increase if you use Ibuprofen more than directed or for longer than directed.

Packaging Info

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

Packaging configurations for Fast Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each dosage unit contains 200 mg of ibuprofen. This medication functions by inhibiting the production of prostaglandins, which are responsible for inflammation and pain signaling in the body. Ibuprofen is commonly utilized in various clinical settings for its analgesic and antipyretic properties.

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 to manage symptoms effectively.

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, it is imperative not to exceed 6 tablets within a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before administration.

Contraindications

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

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

Warnings and Precautions

Ibuprofen may cause 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 a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroids, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen 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, or pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics should seek medical advice before use.

Patients under medical supervision for serious health conditions or those taking aspirin for cardiovascular protection should also consult a healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin. It is advisable for patients to discuss any other medications they are currently taking with their healthcare provider or pharmacist.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or persists beyond three days, or if redness or swelling occurs in the painful area, or if any new symptoms arise, medical advice should be sought promptly.

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 history of allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Patients should be advised to discontinue use and seek medical attention immediately if they experience any of these symptoms.

The use of ibuprofen is associated with 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. Patients should be instructed to stop use and consult a healthcare provider if they experience signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additional warnings indicate that ibuprofen should not be used in patients who have previously experienced allergic reactions to any pain reliever or fever reducer, or in those who are undergoing heart surgery. Patients with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should consult a doctor before using ibuprofen. It is also advised that patients taking aspirin for cardiovascular protection discuss their use of ibuprofen with a healthcare provider, as it may diminish the cardioprotective effects of aspirin.

During treatment, patients are encouraged to take ibuprofen with food or milk to mitigate potential stomach upset. The risk of heart attack or stroke may increase if the medication is used in higher doses or for extended periods beyond the recommended guidelines.

In clinical settings, it is important for patients to be aware of the potential for new symptoms to arise during treatment. If any new symptoms develop, or if existing symptoms worsen or persist beyond 10 days for pain or 3 days for fever, patients should seek medical advice.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is essential prior to use, particularly during the last trimester of pregnancy, as ibuprofen may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

The concomitant use of ibuprofen and aspirin may diminish the cardioprotective effects of aspirin, particularly in patients utilizing aspirin for the prevention of heart attacks or strokes. It is advisable to separate the administration of these medications to optimize the therapeutic benefits of aspirin.

When ibuprofen is used in conjunction with anticoagulants or steroid medications, there is an increased risk of severe gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of gastrointestinal complications when these drugs are co-administered.

Additionally, prolonged use of ibuprofen beyond the recommended dosage may elevate the risk of cardiovascular events, including heart attack and stroke. It is essential to adhere to prescribed dosing guidelines and to evaluate the necessity of continued ibuprofen therapy in patients with a history of cardiovascular disease. Regular assessment of the patient's condition and medication regimen is recommended to mitigate these risks.

Packaging & NDC

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

Packaging configurations for Fast Pain Relief.
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, 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 profile is essential in this population to ensure safe and effective use of the medication.

Pregnancy

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

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of 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 underlying conditions such as kidney disease. It is essential to assess the patient's overall health status, including any comorbidities like high blood pressure, heart disease, liver cirrhosis, or asthma, which may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the degree of renal impairment and individual patient factors.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with concurrent conditions such as high blood pressure, heart disease, kidney disease, or asthma should be evaluated for potential interactions and contraindications related to their hepatic impairment. It is advised that healthcare providers exercise caution and consider these factors when prescribing the medication to this patient population.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose scenario.

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 text.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Providers should inform patients about the potential increased risk of heart attack or stroke associated with using the medication in excess of the directed dosage or for a duration longer than recommended. Patients should be encouraged to consult with their healthcare provider before use if they have a history of stomach problems, such as heartburn, or if they have experienced stomach bleeding.

Additionally, patients should be advised to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also important for patients to consult their doctor before use if they are taking a diuretic or if they are under medical care for any serious condition.

Patients should be informed to speak with their healthcare provider or pharmacist before using the medication if they are taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Lastly, patients should be encouraged to consult their healthcare provider or pharmacist before use if they are taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the safety seal under the cap; the product should not be used if the seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). It is crucial to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to ensure the integrity and efficacy of the product. Proper handling and storage conditions are vital for maintaining product quality.

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.

Drug Information (PDF)

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

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

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

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.