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 2010
Label revision date
April 18, 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
April 18, 2025
Manufacturer
United Natural Foods, Inc. dba UNFI
Registration number
ANDA074937
NDC root
41163-685
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 designed to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also helps reduce fever. This medication is dye-free, alcohol-free, and has a pleasant berry flavor, making it suitable for children aged 2 to 11 years. Each dose contains 100 mg of ibuprofen per 5 mL and can provide relief for up to 8 hours.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or toothache. It’s 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. This makes it a safer choice for those who are pregnant, although you should always consult with your healthcare provider before taking any medication.

Dosage and Administration

Before using this product, it's important to note that it does not 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 provided, which is based on weight. If you can, use your child's weight to determine the dose; if not, you can use their age.

When measuring the dose, always use the enclosed dosing cup, as other devices may not provide accurate measurements. For children, you can repeat the dose every 6 to 8 hours if necessary, but do not give more than four doses in a single day. After each use, wash the dosing cup to keep it clean, and remember to replace the original bottle cap to ensure it remains child-resistant. If your child weighs under 24 pounds (under 2 years), consult a doctor for guidance. For children weighing between 24 and 95 pounds, the dosing chart will help you find the correct amount to give.

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 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. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially 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. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for longer than recommended.

If your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, seek medical attention immediately. Other serious symptoms to watch for include chest pain, difficulty breathing, weakness on one side of the body, or slurred speech. If your child does not find relief within 24 hours, or if fever or pain worsens or lasts more than three days, consult a doctor. Always talk to a healthcare professional before using 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 skin blisters, stop using the medication and seek medical help immediately. Additionally, ibuprofen may lead to severe stomach bleeding, particularly 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. The risk of heart attack and stroke is also increased with NSAID use, especially if taken in higher doses or for longer than recommended.

You should stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if they show symptoms of heart problems or stroke, like chest pain or trouble breathing. If your child does not feel better within 24 hours, if their fever or pain worsens after three days, or if new symptoms arise, contact a healthcare professional. In case of an overdose, get emergency medical help or call 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 take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is 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. This includes potential cardiovascular effects that could impact the fetus.

Before taking ibuprofen or any nonsteroidal anti-inflammatory drug (NSAID), it's crucial to consult with your healthcare provider. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during your pregnancy.

Lactation Use

If you are breastfeeding and considering using this product, it's important to consult your doctor first. There is a possibility that the medication can pass into your breast milk, and the effects of ibuprofen on nursing infants have not 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

When considering this medication for your child, it's important to note that it should not be used in children under 3 years of age unless specifically directed by a doctor. For children aged 2 to 10 years, the dosage depends on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, you should consult a doctor. For those weighing 24-35 lbs (ages 2-3), the recommended dose is 5 mL, while children weighing 36-47 lbs (ages 4-5) should receive 7.5 mL. As the weight increases, so does the dosage, reaching 15 mL for an 11-year-old weighing 72-95 lbs.

Always use the enclosed dosing cup to measure the medication accurately, and if possible, base the dosage on your child's weight rather than age. It's crucial not to use this medication for more than 2 days or to give it to children under 3 years without a doctor's guidance. If your child has been dehydrated due to vomiting or diarrhea, consult a doctor before administering the medication. Lastly, keep the medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center.

Geriatric Use

When considering this medication for older adults, it's important to note that the product does not provide specific directions or complete warnings tailored for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for personalized guidance.

Always discuss any existing health conditions or medications with your doctor, as they can help determine the safest and most effective dosage for you. Your healthcare provider can also monitor for any potential side effects or interactions that may be more relevant for older adults.

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 factors can also influence your care 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 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 can also raise the chances of serious heart issues, like heart attack or stroke, especially if taken in higher doses or for longer than recommended. If your child is on a diuretic (a medication that helps remove excess fluid), 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 and safety of your product, store it 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 that the printed neckband is intact; do not use the product if the neckband is broken or missing, as this could compromise its 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, but do not exceed 4 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.

Before using the medication, shake the bottle well and ensure you find the correct dose on the provided chart. If possible, use your child's weight to determine the dose; otherwise, use their age. Always use the enclosed dosing cup for measurement, and wash it after each use. Do not use the medication if the printed neckband is broken or missing, and store it at room temperature between 20-25°C (68-77°F). Avoid freezing the medication.

FAQ

What is EQUALINE®?

EQUALINE® is a children's ibuprofen oral suspension that acts as a pain reliever and fever reducer. It is dye-free, alcohol-free, and comes in a berry flavor.

What age group is EQUALINE® suitable for?

EQUALINE® is suitable 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. Use only the enclosed dosing cup and do not exceed the recommended dosage.

What are the indications for using EQUALINE®?

EQUALINE® relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

Are there any contraindications for EQUALINE®?

Do not use EQUALINE® if your child has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or if they are undergoing heart surgery.

What should I do if my child experiences side effects?

If your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours, stop use and consult a doctor immediately.

Can I use EQUALINE® during pregnancy?

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

Is it safe to use EQUALINE® while breastfeeding?

Nursing mothers should consult a doctor before using EQUALINE®, as ibuprofen may be excreted in breast milk and its effects on nursing infants are not well studied.

What should I do in case of an overdose?

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

How should I store EQUALINE®?

Store EQUALINE® at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

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 as a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each 5 mL dose contains 100 mg of ibuprofen and is designed for children aged 2 to 11 years. The product is presented in a 4 FL OZ (118 mL) bottle and features a dye-free berry flavor, ensuring a palatable experience for pediatric patients. This formulation is alcohol-free and non-staining, providing a convenient option for caregivers. The effects of the medication can last up to 8 hours.

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 dosage based on the patient's weight or age. It is essential to shake the product well before each use to ensure proper mixing.

For patients weighing under 24 lbs (under 2 years), it is advised to consult a physician for dosing recommendations. For those weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. Patients weighing 36-47 lbs (4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (6-8 years) should be administered 10 mL. For patients weighing 60-71 lbs (9-10 years), the dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing should be performed using only the enclosed dosing cup to ensure accuracy; other dosing devices are not recommended. If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed four doses. After each use, the dosing cup should be washed thoroughly to maintain hygiene.

To ensure child safety, the original bottle cap should be replaced securely after each use to maintain its child-resistant properties. It is crucial to adhere strictly 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 induce 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those concurrently using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases this risk.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, are associated with 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.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, prompt consultation with a physician is advised. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should instruct caregivers to discontinue use and consult a physician 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 attention 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, medical advice should be sought. The presence of redness or swelling in the affected area, as well as the emergence of any new symptoms, also necessitates consultation with a healthcare professional.

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

Side Effects

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

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk 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. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is greater when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients should seek medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to consult a healthcare provider if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Before using this product, it is recommended that patients consult a healthcare professional if they have a history of stomach problems, are experiencing dehydration, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special caution is advised for patients under a doctor's care for serious conditions or those 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, particularly 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 also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including 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 has been linked to an elevated risk of 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 dosage adjustments or increased monitoring to ensure patient safety.

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 dosing, it is recommended to use weight as the primary guide; however, age may be used if weight is not available. The following dosing chart provides specific recommendations based on weight and age:

  • For patients weighing under 24 lbs (under 2 years of age), consult a doctor before use.

  • For patients weighing 24-35 lbs (ages 2-3 years), the dose is 5 mL.

  • For patients weighing 36-47 lbs (ages 4-5 years), the dose is 7.5 mL.

  • For patients weighing 48-59 lbs (ages 6-8 years), the dose is 10 mL.

  • For patients weighing 60-71 lbs (ages 9-10 years), the dose is 12.5 mL.

  • For patients weighing 72-95 lbs (age 11 years), the dose is 15 mL.

It is essential to use only the enclosed dosing cup and not any other dosing device. The medication should not be used for more than 2 days, and if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea, a doctor should be consulted. This product should be kept out of reach of children, and in the event of an overdose, medical help or contact with a Poison Control Center should be sought immediately.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary based on individual patient needs and responses. Given the lack of tailored guidance for this demographic, careful assessment and ongoing evaluation are critical to ensure the safe and effective use of this product in geriatric patients.

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, including potential cardiovascular effects on the developing fetus.

Women who are pregnant or planning to become pregnant should consult a healthcare provider before using ibuprofen to discuss the potential risks and benefits. It is essential to consider alternative pain management options that may be safer during pregnancy.

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 course. Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition.

Healthcare providers should consider the overall health status of patients, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these may further complicate the management of therapy in the context of hepatic impairment. Regular follow-up and reassessment of liver function are advised to ensure patient safety and therapeutic 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 overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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. 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 persistent stomach pain. Additionally, healthcare providers should inform patients to stop use and seek medical attention 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 made aware that 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, 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.

Before initiating treatment, healthcare providers should encourage patients to 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 seek medical advice if the child has asthma or is taking a diuretic.

Finally, healthcare providers should recommend that patients 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. 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 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 be instructed to shake the medication well before use and to refer to the dosing chart for the appropriate dose, ideally based on weight; if weight is not available, age may be used. It is essential to use only the enclosed dosing cup for administration, ensuring it is washed after each use. Patients should also be cautioned against using the medication if the printed neckband is broken or missing. Proper storage conditions include a temperature range of 20-25°C (68-77°F), with a warning not to freeze the product.

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.