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Rexall Ibuprofen

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Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
September 9, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Chewable
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 2010
Label revision date
September 9, 2021
Manufacturer
Dolgencorp, LLC
Registration number
ANDA076359
NDC root
55910-521
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

Children's Ibuprofen is a chewable medication designed for children ages 2 to 11. It comes in grape flavor and contains 100 mg of ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). This medication is used to temporarily relieve fever and minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

When taken, Children's Ibuprofen works by reducing fever and alleviating discomfort, providing relief that can last up to 8 hours. It's important to chew or crush the tablets completely before swallowing to ensure proper absorption.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions like the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before taking this medication, make sure to chew or crush the tablets completely before swallowing them. It's important to follow the dosing instructions carefully, as this product does not provide complete warnings for adult use. Always ensure you do not exceed the recommended dose. You can find the right amount to take by referring to the dosing chart, which is based on weight and age. If you can, use weight to determine the dose; if not, use age.

If you need to take another dose, you can do so every 6 to 8 hours, but remember not to take more than four doses in a single day. For children, the dosing varies: if they weigh under 24 pounds and are under 2 years old, consult a doctor first. For children weighing between 24 to 35 pounds (ages 2-3), the dose is 1 tablet; for those weighing 36 to 47 pounds (ages 4-5), it's 1 ½ tablets; for 48 to 59 pounds (ages 6-8), it's 2 tablets; for 60 to 71 pounds (ages 9-10), it's 2 ½ tablets; and for those weighing 72 to 95 pounds (age 11), the dose is 3 tablets. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after your child has undergone heart surgery, as it may pose serious risks in these situations.

Always prioritize your child's safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult with a healthcare professional for personalized advice.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as faintness, vomiting blood, or black stools, or shows signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or any skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, so it’s important to use this medication only as directed. If your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away. You should not use ibuprofen for more than two days in children under three years old unless directed by a healthcare professional.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop using ibuprofen and consult a doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness on one side of the body), or if their condition does not improve within 24 hours. If fever or pain worsens or lasts more than three days, or if any new symptoms arise, reach out to a healthcare provider.

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.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help if you think an overdose has occurred.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that ibuprofen is not recommended, especially during the third trimester. Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy can pose risks to your baby, particularly in the later stages. There is a potential risk of serious fetal cardiovascular issues, such as the premature closure of a vital blood vessel called the ductus arteriosus.

Before taking any medication, including ibuprofen, you should consult your healthcare provider. They may suggest dosage adjustments or alternative treatments to ensure your safety and that of your baby. It's best to avoid using ibuprofen unless your doctor specifically advises you to do so.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it’s important to consult your doctor first. This is because ibuprofen can potentially pass into your breast milk, which may pose risks to your nursing infant. Therefore, exercising caution is advised when taking this medication while breastfeeding. Always prioritize your health and your baby's safety by discussing any medications with your healthcare provider.

Pediatric Use

When considering this medication for your child, it's important to follow specific guidelines to ensure their safety. For children under 3 years old, you should only use it if directed by a doctor, and it should not be used for more than 2 days. The recommended dosage varies based on your child's weight and age. For instance, if your child weighs between 24-35 pounds and is 2-3 years old, they can take 1 tablet. Always refer to the dosing chart for precise amounts based on their weight, and if weight isn't available, you can use their age as a guide.

Make sure to repeat the dose every 6-8 hours if necessary, but do not exceed 4 doses in a single day. This medication is designed for children aged 2 to 11, so it's crucial to adhere to these recommendations to keep your child safe and healthy.

Geriatric Use

When it comes to using REXALL IBUPROFEN, there are no specific recommendations or dosage adjustments for older adults. This means that the standard dosage applies to you, just like it does for younger adults. However, it's always important to consult with your healthcare provider before starting any new medication, especially if you have other health conditions or are taking other medications.

Since there are no special precautions or safety concerns noted for elderly patients, you can feel reassured that the information provided is applicable to your situation. Always keep an open line of communication with your doctor about any changes in your health or concerns you may have while using this medication.

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 if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed 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 (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 closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of the treatment.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these may also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of serious stomach bleeding increases. This risk is also heightened if your child is taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with a healthcare provider if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and any lab tests with your doctor is crucial to ensure safety and avoid serious complications.

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). This helps maintain its effectiveness and safety.

Before using the product, check that the printed seal under the cap is intact. If the seal is broken or missing, do not use the product, as this could indicate that it has been compromised. Always handle the product with care to ensure your safety and the product's integrity.

Additional Information

You should take this medication orally, making sure to chew or crush the tablets completely before swallowing. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. It's important to keep this medication out of reach of children.

If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. To avoid stomach upset, consider taking the medication with food or milk. Watch for serious symptoms in children, such as faintness, vomiting blood, bloody or black stools, persistent stomach pain, chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. If your child does not feel better within 24 hours, or if fever or pain worsens or lasts more than three days, contact a healthcare professional. Redness or swelling in the painful area should also be evaluated.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is a chewable pain reliever and fever reducer available in 100 mg tablets with a grape flavor, suitable for children ages 2 to 11.

How does Children's Ibuprofen work?

It reduces fever and relieves minor aches and pains associated with the common cold, flu, sore throat, headaches, and toothaches.

How should I administer Children's Ibuprofen?

You should chew or crush the tablets completely before swallowing. If needed, you can repeat the dose every 6-8 hours, but do not exceed 4 doses in a day.

What is the dosing chart for Children's Ibuprofen?

For children under 2 years, consult a doctor. For ages 2-3 years, give 1 tablet; 4-5 years, 1 ½ tablets; 6-8 years, 2 tablets; 9-10 years, 2 ½ tablets; and for 11 years, 3 tablets.

Are there any warnings associated with Children's Ibuprofen?

Yes, it may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I use Children's Ibuprofen during pregnancy?

Ibuprofen is contraindicated during pregnancy, especially in the third trimester, due to potential risks to the fetus.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or if symptoms worsen or do not improve within 24 hours.

How should I store Children's Ibuprofen?

Store it between 20-25°C (68-77°F) and do not use if the printed seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Rexall Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children’s Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) formulated as chewable tablets for pediatric use in children aged 2 to 11 years. Each tablet contains 100 mg of ibuprofen and is designed to provide effective pain relief and fever reduction. The tablets are flavored with grape to enhance palatability. Each dose lasts up to 8 hours, and it is recommended that the tablets be chewed or crushed completely before swallowing. The product is supplied in a package containing 24 chewable tablets.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. This product does not contain directions or complete warnings for adult use. Healthcare professionals are advised to ensure that patients do not exceed the recommended dosage.

Dosing should be determined using the chart provided below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative. If necessary, doses may be repeated every 6 to 8 hours, but it is important not to exceed a total of 4 doses in a 24-hour period.

Dosing Chart:

  • For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is recommended.

  • For patients weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb (ages 4-5 years), the recommended dose is 1 ½ tablets.

  • For patients weighing 48-59 lb (ages 6-8 years), the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb (ages 9-10 years), the recommended dose is 2 ½ tablets.

  • For patients weighing 72-95 lb (age 11 years), the recommended dose is 3 tablets.

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 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

NSAIDs, excluding aspirin, are also linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition. It is advised to consult a physician promptly in such cases. Additionally, ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if the child exhibits any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, signs of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical advice should be sought. Any new or unusual symptoms that arise should also prompt consultation with a healthcare professional.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess or for longer durations than directed.

In clinical settings, severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and seek medical advice if they experience 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, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare professional. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a medical evaluation.

Before using ibuprofen, it is essential for patients to consult a healthcare provider if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. It is also recommended to consult a doctor or pharmacist if the patient is under care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, there is an increased risk of severe gastrointestinal bleeding. This risk is further amplified if the patient is also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen.

In pediatric patients, it is advisable to consult a healthcare professional if the child is concurrently receiving diuretic therapy, as this may necessitate careful monitoring or dosage adjustments.

Packaging & NDC

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

Packaging configurations for Rexall Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not be administered this medication unless directed by a healthcare professional. For children aged 2 to 11 years, the following dosing guidelines apply based on weight and age:

  • For patients weighing under 24 lb and under 2 years, consultation with a doctor is advised.

  • For those weighing 24-35 lb and aged 2-3 years, the recommended dose is 1 tablet.

  • For patients weighing 36-47 lb and aged 4-5 years, the recommended dose is 1.5 tablets.

  • For those weighing 48-59 lb and aged 6-8 years, the recommended dose is 2 tablets.

  • For patients weighing 60-71 lb and aged 9-10 years, the recommended dose is 2.5 tablets.

  • For those weighing 72-95 lb and aged 11 years, the recommended dose is 3 tablets.

Dosing should primarily be based on weight; if weight is not available, age may be used as a secondary guide. Doses may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. The medication is indicated for use in children aged 2 to 11 years, as specified on the principal display panel. It is recommended that this medication not be used for more than 2 consecutive days.

Geriatric Use

Elderly patients do not have specific recommendations for geriatric use, dosage adjustments, safety concerns, or special precautions associated with REXALL IBUPROFEN as outlined in the prescribing information. Therefore, healthcare providers should consider the general principles of prescribing nonsteroidal anti-inflammatory drugs (NSAIDs) in this population, including the potential for increased sensitivity to adverse effects and the need for careful monitoring of renal function and gastrointestinal health. It is advisable to assess each elderly patient individually, taking into account their overall health status and concurrent medications.

Pregnancy

Ibuprofen is contraindicated in pregnancy, particularly during the third trimester. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may pose risks to the fetus, especially in the later stages. There is a potential risk of fetal cardiovascular effects, such as premature closure of the ductus arteriosus, which can have significant implications for fetal health.

Due to these concerns, dosage adjustments may be necessary, and it is advised that pregnant patients consult a healthcare provider before using ibuprofen. Special precautions should be taken, and pregnant women are encouraged to avoid using ibuprofen unless specifically directed by a healthcare professional.

Lactation

Nursing mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. Caution is advised when administering ibuprofen to lactating mothers due to the potential risk to the breastfed infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, or kidney disease, which may further complicate their treatment regimen.

Healthcare providers should exercise caution and consider alternative therapies in patients with severe hepatic impairment to ensure safety and efficacy.

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 may include supportive care and symptomatic treatment as necessary. Healthcare providers should remain vigilant for any signs of adverse reactions and be prepared to implement appropriate medical interventions based on the clinical presentation.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs, they should stop use and seek medical advice.

It is important to inform patients that if the child does not experience any relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should consult a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a doctor.

Patients should be made aware that while using this product, mouth or throat burning may occur; therefore, it is advisable to administer it with food or water. If stomach upset occurs, taking the medication with food or milk may help alleviate discomfort.

Healthcare providers should recommend that patients consult a doctor before use if any of the following apply: the stomach bleeding warning is relevant to the child, there is a history of stomach problems such as heartburn, the child has experienced serious side effects from pain relievers or fever reducers, the child has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea. Additionally, if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or is taking a diuretic, a doctor should be consulted prior to use.

Lastly, patients should be encouraged to ask a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or compromise of the product. Proper handling and storage conditions are essential to ensure the safety and effectiveness of the product.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with tablets to be chewed or crushed completely before swallowing. Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients should take the medication with food or milk if gastrointestinal upset occurs. Parents should monitor for signs of serious adverse effects in children, including symptoms of stomach bleeding (e.g., faintness, vomiting blood, bloody or black stools, persistent stomach pain), signs of heart problems or stroke (e.g., chest pain, difficulty breathing, unilateral weakness, slurred speech, leg swelling), lack of relief within the first 24 hours, worsening fever or pain lasting more than three days, or any redness or swelling in the affected area.

Drug Information (PDF)

This file contains official product information for Rexall 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 Rexall 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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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.