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Green Guard Ibupro 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 2016
Label revision date
September 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, 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 2016
Label revision date
September 9, 2025
Manufacturer
Unifirst First Aid Corporation
Registration number
ANDA075010
NDC root
47682-610
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Ibupro relief is a pain reliever and fever reducer that contains ibuprofen (a type of medication known as a nonsteroidal anti-inflammatory drug, or NSAID) at a strength of 200 mg per tablet. It is designed to temporarily relieve minor aches and pains, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain. Additionally, it helps to reduce fever.

This medication works by blocking certain substances in the body that cause inflammation and pain, providing you with relief when you need it most. Ibupro relief is comparable to other products containing ibuprofen, such as Advil.

Uses

You can use this medication to temporarily relieve minor aches and pains from various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even pain associated with the common cold or minor arthritis. Additionally, it can help reduce fever, providing you with some comfort when you're not feeling well.

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

Dosage and Administration

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

For children under 12 years old, it’s best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

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, do not take it right before or after heart surgery, as this could pose serious risks to your health. Always consult with your healthcare provider if you have any questions or concerns about your medications.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in individuals allergic to aspirin. Symptoms of an allergic reaction may include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, and blisters. Additionally, this medication can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume alcohol regularly, or exceed the recommended dosage.

There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, particularly if used in higher amounts or for extended periods. If you experience symptoms such as faintness, vomiting blood, bloody or black stools, chest pain, difficulty breathing, or weakness on one side of your body, you should stop using ibuprofen and consult a doctor immediately. Always talk to your healthcare provider before using ibuprofen if you have any underlying 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, skin reddening, asthma (wheezing), facial swelling, rash, shock, or blisters. If you experience any of these symptoms, stop using the product and seek emergency medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should stop using ibuprofen and contact your doctor if you notice signs of stomach bleeding (like feeling faint, vomiting blood, or having black stools), experience symptoms of heart problems or stroke (such as chest pain or weakness on one side of the body), or if your pain or fever worsens or lasts longer than the recommended time. Always be alert for any new or unexpected symptoms and consult your healthcare provider as needed.

Overdose

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

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. Specifically, you should avoid taking ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so. Using ibuprofen during this time can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking professional advice.

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 if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being 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 professional guidance when it comes to treating your child's health.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 or older, you may have a higher chance of experiencing severe stomach bleeding. Additionally, using more than the recommended dose or taking medication for longer than advised can increase your risk of heart attack, heart failure, and stroke.

To help minimize these risks, it's best to use the smallest effective dose and avoid taking the medication for more than 10 days unless your doctor instructs you otherwise. If you experience stomach upset, consider taking your medication with food or milk to ease discomfort. Always consult with your healthcare provider for personalized advice and guidance.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition. This means that the information available does not provide special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

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

When handling the product, make sure to use only tamper-evident sealed packets. If you notice any packets that are opened or torn, do not use them, as this could compromise the safety and effectiveness of the product. Always prioritize these guidelines to maintain the integrity of your device.

Additional Information

No further information is available.

FAQ

What is Ibupro relief?

Ibupro relief is a pain reliever and fever reducer that contains the active ingredient ibuprofen 200 mg.

What are the uses of Ibupro relief?

It temporarily relieves minor aches and pains from headaches, toothaches, backaches, menstrual cramps, common colds, muscular aches, and minor arthritis pain, and it also reduces fever.

How should adults and children 12 years and older take Ibupro relief?

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

What should children under 12 years do?

Children under 12 years should ask a doctor before use.

What are the warnings associated with Ibupro relief?

Ibupro relief may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack or stroke. You should stop use and seek medical help if you experience symptoms of these conditions.

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

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

Can I take Ibupro relief if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use, especially after 20 weeks of pregnancy.

How should I store Ibupro relief?

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

What should I do if I have an allergic reaction?

If you experience an allergic reaction, stop use and seek medical help right away.

Packaging Info

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

Packaging configurations for Green Guard Ibupro Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

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

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

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Heart Attack or Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in excess of the recommended dosage or for extended periods.

Monitoring and Consultation Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should seek medical advice if they exhibit signs of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients should also be instructed to stop use and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new or unexpected symptoms arise.

In cases of an allergic reaction, immediate cessation of ibuprofen and prompt medical attention are essential.

Side Effects

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

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using the product. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of this adverse reaction.

Patients should be aware that NSAIDs, excluding aspirin, may elevate the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the product is used in higher doses or for extended periods.

Participants in clinical trials and postmarketing experiences have indicated that patients should discontinue use and consult a healthcare provider if they exhibit signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new or unexpected symptoms arise.

Before using this product, patients should consult a healthcare professional if they have experienced serious side effects from pain relievers or fever reducers, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if they have previously suffered a stroke. It is also advisable to seek guidance if taking a diuretic or if under a physician's care for any serious condition. Additionally, patients taking aspirin for heart attack or stroke should consult a doctor or pharmacist, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Green Guard Ibupro 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 for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this medication. Therefore, caution is advised when prescribing to this population.

Additionally, the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, is heightened in elderly patients who exceed the recommended dosage or duration of use. It is essential to adhere to the smallest effective dose and to limit the duration of treatment to no longer than 10 days unless otherwise directed by a healthcare provider.

To mitigate gastrointestinal discomfort, it is recommended that this medication be taken with food or milk if stomach upset occurs. Continuous monitoring and careful consideration of the risks versus benefits are crucial when treating geriatric patients with this 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 after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later 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 provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should carefully consider the potential risks and benefits when advising lactating mothers on the use of this medication.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive administration of the medication.

In the event of suspected overdosage, it is recommended that healthcare providers assess the patient's clinical status and consider the following general management procedures:

  1. Assessment of Symptoms: Healthcare professionals should monitor for any unusual or severe symptoms that may arise, which could indicate an adverse reaction to the medication. Symptoms may vary depending on the drug's pharmacological profile and the patient's individual response.

  2. Supportive Care: Supportive measures should be initiated as necessary. This may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

  3. Contact Poison Control: In cases of suspected overdosage, it is advisable to contact a poison control center for guidance on specific management strategies tailored to the medication involved.

  4. Consideration of Antidotes: If applicable, healthcare providers should be aware of any available antidotes or specific treatments that may mitigate the effects of the overdosage.

  5. Documentation and Reporting: It is crucial to document the incident thoroughly and report it to the appropriate regulatory authorities as required.

Healthcare professionals are encouraged to consult the product's prescribing information for any additional guidance on managing overdosage and to remain informed about the latest clinical recommendations.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SPL code 90375-7.

Patient Counseling

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

Patients 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.

Healthcare providers should counsel patients to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be advised to seek medical attention if they exhibit symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

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

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

Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be advised to consult a doctor before using this medication. Additionally, patients taking a diuretic or those under a doctor's care for any serious condition should seek medical advice prior to use.

Finally, patients should be encouraged to discuss with their doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. It is also important for patients to inform their healthcare provider if they are taking any other medications.

Storage and Handling

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

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Green Guard Ibupro 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 Green Guard Ibupro 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.