Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Equaline Ibuprofen

Last content change checked dailysee data sync status

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 2004
Label revision date
May 8, 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 2004
Label revision date
May 8, 2025
Manufacturer
United Natural Foods, Inc. dba UNFI
Registration number
ANDA074937
NDC root
41163-166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

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

Drug Overview

EQUALINE® is a children's ibuprofen oral suspension that provides effective relief for minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also helps reduce fever, making it a useful option for parents looking to ease their child's discomfort. This medication is designed for children aged 2 to 11 years and comes in a pleasant bubble gum flavor, ensuring that it is more appealing for young ones to take.

As a nonsteroidal anti-inflammatory drug (NSAID), EQUALINE® works by reducing inflammation and pain, providing relief that can last up to 8 hours. With its alcohol-free formulation, it offers a safe choice for managing your child's symptoms.

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, make sure to shake the bottle well. It’s important to follow the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age. Always use the enclosed dosing cup to measure the dose accurately—do not use any other device.

For most cases, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. After each use, wash the dosing cup to keep it clean. Finally, make sure to replace the original bottle cap to keep it child-resistant and safe. If your child weighs under 24 pounds or is under 2 years old, please consult a doctor for the appropriate dose.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergy 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 fatal, 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 trouble breathing), seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever or if symptoms worsen or persist beyond a few days. Always check with a healthcare provider before giving ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those 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, especially if used in higher doses or for longer than recommended. If your child experiences severe sore throat symptoms, high fever, or if their sore throat lasts more than two days, consult a doctor right away.

You should stop using ibuprofen and contact a doctor if your child shows signs of stomach bleeding (like fainting, vomiting blood, or having black stools), symptoms of heart problems or stroke (such as chest pain or weakness on one side of the body), or if they do not feel better within 24 hours. If fever or pain worsens or lasts more than three days, or if new symptoms appear, seek medical advice promptly.

Overdose

Taking too much ibuprofen can lead to serious symptoms. You might experience nausea (feeling sick), vomiting, stomach pain, drowsiness (feeling unusually sleepy), headache, blurred vision, ringing in the ears, diarrhea, an increased heart rate, or even difficulty breathing. If you notice any of these signs after taking ibuprofen, it’s important to act quickly.

In the event of an overdose, seek immediate medical help or contact a Poison Control Center. Your health and safety are the top priority, so don’t hesitate to get assistance if you suspect you’ve taken too much.

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, including potential cardiovascular effects.

Before taking ibuprofen, you should always consult your healthcare provider. They can help determine if it's appropriate for you and may suggest dosage adjustments based on your stage of pregnancy and individual health needs. Your health and the health of your baby are the top priority, so make sure to discuss any medications with your doctor.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, children weighing under 24 lbs should have their dosage determined by a doctor, while those weighing 24-35 lbs (ages 2-3) can take 5 mL, and the dosage increases with weight and age up to 15 mL for an 11-year-old weighing 72-95 lbs.

Always consult a doctor if your child has a history of allergies to pain relievers, stomach issues, or serious health conditions like high blood pressure or asthma. If your child has been vomiting or has diarrhea, or if they are taking other medications, it's best to seek medical advice before administering this medication. Remember, do not use this medication for more than 2 days without a doctor's guidance, and keep it out of reach of children.

Geriatric Use

When considering this product for older adults, it's important to note that it lacks specific directions or complete warnings for adult use. If you or a loved one has any underlying health conditions such as high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, or a history of stroke, it’s crucial to consult a doctor before using this product. Your healthcare provider can help ensure that it’s safe and appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis, or a history of stroke can complicate your situation. These factors may require careful monitoring and adjustments to your treatment plan to ensure your safety and well-being.

Make sure to discuss your kidney health with your healthcare provider, as they may need to adjust your medication dosages or monitor your kidney function more closely. Keeping an open line of communication about your overall health will help you manage your conditions effectively.

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 (blood tests that check how well your liver is working). This is especially crucial if you also have other conditions like high blood pressure, heart disease, or kidney disease.

Always communicate openly with your doctor about your liver health and any other medical issues you may have. This will help ensure that you receive the safest and most effective care tailored to your needs.

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 stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Using ibuprofen for longer than recommended can raise the chances of serious heart issues, including heart attack and stroke. If your child is taking a diuretic (a medication that helps remove excess fluid from the body), it's crucial to consult with a healthcare provider before using ibuprofen. Always discuss any medications or tests with your doctor to ensure safety and effectiveness.

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). It's important to avoid freezing the product, as this can damage it. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

By following these simple storage and handling guidelines, you can help maintain the product's effectiveness and ensure your safety.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. If you experience stomach upset, it's best to take the medication with food or milk. Always keep the medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

When using this product, make sure to use only the enclosed dosing cup for measuring your dose, as other devices may not provide accurate measurements. After each use, wash the dosing cup to keep it clean. Remember to replace the original bottle cap to maintain its child-resistant feature. Please note that this product does not include complete directions or warnings for adult use.

FAQ

What is EQUALINE®?

EQUALINE® is a children's ibuprofen oral suspension that contains 100 mg of ibuprofen per 5 mL.

What does EQUALINE® do?

It acts as a pain reliever and fever reducer, helping to relieve minor aches and pains from conditions like the common cold, flu, sore throat, headache, and toothache.

What age group is EQUALINE® suitable for?

EQUALINE® is intended for children aged 2 to 11 years.

How should I dose EQUALINE®?

You should find the right dose on the dosing chart based on your child's weight or age, and use only the enclosed dosing cup.

What are the dosing instructions for EQUALINE®?

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

What should I do if my child has a stomach upset?

If your child experiences stomach upset, give EQUALINE® with food or milk.

What are the potential side effects of EQUALINE®?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke, especially if used improperly.

When should I consult a doctor before using EQUALINE®?

Consult a doctor if your child has a history of stomach problems, is taking other medications, or has conditions like high blood pressure or asthma.

Is EQUALINE® safe to use during pregnancy?

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

How should I store EQUALINE®?

Store EQUALINE® at 20-25°C (68-77°F) and do not freeze it.

Packaging Info

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

Packaging configurations for Equaline Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

EQUALINE® Children’s ibuprofen is an oral suspension formulated to provide pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). This product is designed for pediatric use in children aged 2 to 11 years and offers effects that can last up to 8 hours. The suspension is presented in a 4 FL OZ (118 mL) bottle and features a bubble gum flavor, making it more palatable for children. Additionally, the formulation is alcohol-free, ensuring safety for its intended age group.

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 effects associated with this drug. Furthermore, no nonteratogenic effects have been reported.

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 utilized for accurate measurement; no other dosing devices should be employed.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a physician for the appropriate dosage. For patients weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (ages 4-5 years), the dose is 7.5 mL. Patients weighing 48-59 lbs (ages 6-8 years) should receive 10 mL, while those weighing 60-71 lbs (ages 9-10 years) should be administered 12.5 mL. For patients 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 ensure hygiene. It is important to replace the original bottle cap after use to maintain child resistance. Healthcare professionals should emphasize to caregivers the importance of not exceeding the recommended dosage.

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 immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may 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 emergency medical assistance.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently taking anticoagulants or steroid medications, and individuals using other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

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 is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be administered for more than two days without physician guidance, especially in children under three years of age.

Monitoring for signs of serious adverse effects is crucial. Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice 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. Additionally, symptoms suggestive 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, further medical assessment is necessary. Caregivers should also be vigilant for any new symptoms or the presence of redness or swelling in the affected area, which may indicate a need for reevaluation.

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.

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 is amplified when the medication is used in excess of the directed dosage or duration.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these 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 direction.

Parents and caregivers should discontinue use and seek medical advice if the child exhibits 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 the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

Before administering ibuprofen, it is crucial to consult a doctor if the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, children with asthma or those taking diuretics should seek medical advice prior to use. It is also advisable to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that may impact patient safety and treatment efficacy.

Allergic Reactions Ibuprofen may induce severe allergic reactions in individuals with a known allergy to aspirin. It is crucial for healthcare providers to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is further elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is recommended in patients receiving these combinations.

Cardiovascular Risks The use of ibuprofen may elevate the risk of serious cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. Healthcare providers should counsel patients on the importance of adhering to prescribed dosages and durations of therapy.

Diuretics Patients taking diuretics should consult their healthcare provider prior to initiating ibuprofen therapy. The interaction between these medications may necessitate careful monitoring and potential dosage adjustments to mitigate risks.

Packaging & NDC

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

Packaging configurations for Equaline 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 follows:

  • Under 24 lbs: Consult a doctor (under 2 years)

  • 24-35 lbs: 5 mL (2-3 years)

  • 36-47 lbs: 7.5 mL (4-5 years)

  • 48-59 lbs: 10 mL (6-8 years)

  • 60-71 lbs: 12.5 mL (9-10 years)

  • 72-95 lbs: 15 mL (11 years)

Healthcare professionals should advise parents to consult a doctor if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, stomach problems such as heartburn, or serious side effects from pain relievers or fever reducers. Additionally, consultation is recommended if the child has not been drinking fluids, has lost significant fluid due to vomiting or diarrhea, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Children taking diuretics or under a doctor's care for any serious condition should also be evaluated by a healthcare professional before use. The medication should not be used for more than 2 days or administered to children under 3 years of age unless directed by a doctor. If necessary, doses may be repeated every 6-8 hours, not exceeding 4 doses in a 24-hour period. It is important to keep this medication out of reach of children.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. It is essential for healthcare providers to consult with a physician if geriatric patients have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Due to the potential for altered pharmacokinetics and increased sensitivity to medications in this population, careful monitoring and assessment of the patient's overall health status are recommended. Adjustments to dosage or treatment plans may be necessary based on individual patient needs and responses.

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 pose risks such as potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to ensure that the benefits outweigh any potential risks. Additionally, dosage adjustments may be necessary based on the stage of pregnancy and individual health considerations. It is essential for healthcare professionals to evaluate each case carefully when considering the use of ibuprofen in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in lactating mothers. Additionally, the provided information does not indicate the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function should be assessed for potential changes in drug clearance. It is essential to evaluate 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 further complicate the management of therapy in this population. Regular monitoring of renal function is recommended to ensure safe and effective use of the medication in patients with compromised renal status.

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 course to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic impairment.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach and monitoring requirements.

Overdosage

Overdosage of ibuprofen can lead to a range of severe symptoms that may significantly impact the patient's health. The clinical manifestations of ibuprofen overdosage include, but are not limited to, the following:

Symptoms of Overdosage Patients may experience gastrointestinal disturbances such as nausea, vomiting, and stomach pain. Neurological symptoms may present as drowsiness, headache, blurred vision, and tinnitus (ringing in the ears). Additionally, patients may exhibit gastrointestinal symptoms like diarrhea, cardiovascular effects such as increased heart rate, and respiratory difficulties, including difficulty breathing.

Recommended Actions In the event of an ibuprofen overdose, it is imperative to seek immediate medical attention. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center for further guidance. Prompt intervention is crucial to manage the symptoms effectively and mitigate potential complications associated with ibuprofen overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Reports of serious adverse reactions have been received through voluntary reporting and surveillance programs. These include allergic reactions characterized by hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding, heart attack, and stroke have been documented. Other unspecified serious side effects have also been reported.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that this product should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this medication right before or after heart surgery.

Patients should be instructed to stop 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. Furthermore, healthcare providers should emphasize the importance of seeking 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 also be informed to discontinue use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When administering this product, healthcare providers should recommend giving it with food or milk if stomach upset occurs. It is essential to advise patients to consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues such as heartburn.

Patients should be encouraged to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea. Additionally, healthcare providers should recommend consulting a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Lastly, patients should be advised to consult a doctor or pharmacist before use if the child is taking a diuretic or is under medical care for any serious condition, as well as before using this product if the child is taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, ensuring that only intact and properly sealed items are utilized.

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.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and instructing patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. It is crucial to use only the enclosed dosing cup for administration, avoiding any other dosing devices, and to replace the original bottle cap to ensure child resistance. Patients should also be reminded to wash the dosage cup after each use. Notably, the product does not include directions or complete warnings for adult use.

Drug Information (PDF)

This file contains official product information for Equaline 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 Equaline 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

Last AI update:

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.