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Equate Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
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
May 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
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
May 23, 2025
Manufacturer
Wal-Mart Stores Inc
Registration number
ANDA074937
NDC root
49035-660
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

Equate™ is a children's ibuprofen oral suspension that provides relief from minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also helps to reduce fever. This medication is designed for children aged 2 to 11 years and can last up to 8 hours, making it a convenient option for managing discomfort in young ones.

The suspension is alcohol-free and comes in a pleasant grape flavor, making it easier for children to take. Each 5 mL dose contains 100 mg of ibuprofen, and a dosage cup is included for accurate measurement.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It is also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus if taken during pregnancy.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You should find the right dose by referring to the dosing chart, which is based on your child's weight or age.

Use the enclosed dosing cup to measure the dose accurately; do not use any other device. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times a day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. If your child weighs under 24 pounds or is under 2 years old, consult a doctor for the appropriate dose. For children weighing between 24 to 95 pounds, the dosing chart provides specific amounts to use based on their weight.

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 ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize safety by following these guidelines closely. If you have any concerns or questions about your child's health or 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, asthma (wheezing), shock, skin reddening, rash, and 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. Symptoms to watch for include chest pain, trouble breathing, weakness on one side of the body, slurred speech, and swelling in the legs. If your child experiences any signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if their symptoms worsen or do not improve within a few days, it’s important to consult a doctor immediately. Always seek medical advice if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

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.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby. These risks can include potential heart problems and kidney issues for the fetus.

Before taking ibuprofen or any medication, you should always consult your healthcare provider. They can help you understand the safest options for managing pain or discomfort during your pregnancy.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, and the effects of ibuprofen on nursing infants haven't been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years old unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight and age, so it's essential to follow the dosing chart carefully. For example, a child weighing 24-35 pounds (2-3 years) should receive 5 mL, while a child weighing 72-95 pounds (11 years) can take 15 mL. Remember, do not use this medication for more than 2 days without consulting a doctor.

Always keep the medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center. Before giving this medication, consult a doctor if your child has any serious health conditions, is taking other medications, or has a history of allergies or stomach issues. If your child experiences symptoms like faintness, vomiting blood, or if their pain or fever worsens or lasts more than three days, stop use and contact a doctor right away.

Geriatric Use

When considering the use of Equate Ibuprofen Children's Oral Suspension for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions for elderly patients.

If you or a caregiver are considering this medication, it’s advisable to consult with a healthcare professional to ensure it is appropriate for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals.

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 your health and seek professional advice when managing your 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 your 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 your child is taking medications. For instance, if your child is 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 stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

To ensure your child's safety, always consult with a healthcare provider before starting any new medication or if your child is already taking other drugs. This way, you can help prevent serious side effects and ensure the best care for your child.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the device. Before using, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability of your device.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. To help prevent stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup for accurate measurement, and make sure to wash it after each use.

It's important to keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is equate™?

Equate™ is a Children's Ibuprofen Oral Suspension that acts as a pain reliever and fever reducer, containing 100 mg of ibuprofen per 5 mL.

What age group can use equate™?

Equate™ is intended for children aged 2 to 11 years.

How long does the effect of equate™ last?

The effects of equate™ can last up to 8 hours.

What should I do before using equate™?

Shake well before using and use only the enclosed dosing cup to measure the dose.

How often can I give equate™ to my child?

You can repeat the dose every 6-8 hours, but do not exceed 4 doses in a day.

What are the dosing recommendations for equate™?

Dosing varies by weight and age; for example, children weighing 24-35 lbs (2-3 years) should receive 5 mL.

Are there any contraindications for using equate™?

Do not use equate™ if your child has had an allergic reaction to ibuprofen or any other pain reliever, or if they are about to undergo heart surgery.

What should I do if my child experiences side effects?

Stop using equate™ and consult a doctor if your child shows signs of stomach bleeding, heart problems, or if symptoms worsen.

Is equate™ safe during pregnancy?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated during the third trimester.

Can nursing mothers use equate™?

Nursing mothers should consult a doctor before using equate™, as ibuprofen may be excreted in breast milk.

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.

Packaging Info

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

Packaging configurations for Equate Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

equate™ is an oral suspension formulation containing ibuprofen, comparable to the active ingredient in Children’s Motrin®. Each 5 mL dose delivers 100 mg of ibuprofen, serving as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. This product is indicated for use in children aged 2 to 11 years and provides effects that may last up to 8 hours. The formulation is alcohol-free and is flavored with grape. Each bottle contains 4 fluid ounces (118 mL) of the suspension, and a dosage cup is included for accurate measurement.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be utilized.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For those weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL. For patients weighing 36-47 lbs (ages 4-5 years), the dose is 7.5 mL. For those weighing 48-59 lbs (ages 6-8 years), the dose is 10 mL. For patients weighing 60-71 lbs (ages 9-10 years), the recommended dose is 12.5 mL, and for those weighing 72-95 lbs (age 11 years), the dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap should be replaced securely after each use. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 carries a 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.

Healthcare professionals should be aware that 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 escalates with the use of higher doses or prolonged treatment.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. 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.

Healthcare providers should advise caregivers to discontinue use and seek medical attention if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—immediate medical evaluation is warranted.

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 consultation is recommended. Any new symptoms that develop should also prompt a discussion with a healthcare professional.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

There is also a significant risk associated with the use of NSAIDs, excluding aspirin, for heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or extended duration of use.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly.

In the event of symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, patients are advised to discontinue use and consult a healthcare professional. Similarly, symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention.

Patients should also be aware that if relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the affected area or the emergence of new symptoms should also prompt consultation with a healthcare provider.

Before using ibuprofen, it is recommended that patients consult a doctor if they have a history of stomach issues, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, those under a doctor's care for serious conditions or taking other medications should seek professional guidance prior to use.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to patients with such allergies.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further amplified when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen, especially those who are concurrently taking anticoagulants, steroids, or other NSAIDs. Consultation with a physician is recommended if the patient is on any additional medications to ensure safe and effective use of ibuprofen.

Packaging & NDC

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

Packaging configurations for Equate Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age, as outlined in the following chart:

  • Under 24 lbs / Under 2 years: Ask a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

The medication should not be used for more than 2 days in children under 3 years of age unless directed by a doctor. It is essential to keep the medication out of reach of children. In the event of an overdose, medical help or contact with a Poison Control Center should be sought immediately.

Before administering this medication, healthcare professionals should advise parents to consult a doctor if the child is under a doctor’s care for any serious condition, taking other medications, has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, or has gastrointestinal issues. Additional caution is warranted for children with dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or those taking diuretics.

Parents should be instructed to stop use and consult a doctor if the child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or lasts more than 3 days, if redness or swelling is present in the painful area, or if any new symptoms appear, medical advice should be sought.

Geriatric Use

There is no specific information regarding the use of Equate Ibuprofen Children's Oral Suspension in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful clinical judgment. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with adverse fetal outcomes, such as cardiovascular effects and renal impairment.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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 is recommended throughout the treatment period to ensure safety and efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of liver function is crucial to determine the appropriateness of continued therapy and to make any necessary adjustments to the treatment regimen.

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 overdose situations, as timely medical help can significantly influence outcomes. 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, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 ongoing safety monitoring.

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. It is recommended to administer the medication with food or milk if the child experiences stomach upset.

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, healthcare providers should inform patients to stop use and seek medical advice 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.

Patients should be counseled to monitor the child’s response to treatment. If the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond three days, they should contact a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a consultation with a doctor.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if any of the following conditions apply: the child has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients should be advised to discuss the use of this medication if the child has asthma or is taking a diuretic.

Finally, healthcare providers should encourage patients to consult a doctor or pharmacist before use if the child is currently under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, healthcare professionals should ensure that the printed neckband is intact; the product should not be used if the neckband is broken or missing, as this may indicate tampering or compromise of the product's safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs and to use only the enclosed dosing cup for accurate measurement, ensuring it is washed after each use.

Patients should be counseled 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.

Drug Information (PDF)

This file contains official product information for Equate 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 Equate 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.