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Equaline Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
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
April 7, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
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
April 7, 2025
Manufacturer
United Natural Foods, Inc. dba UNFI
Registration number
ANDA075217
NDC root
41163-255
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 an infants’ ibuprofen oral suspension designed for children aged 6 months to 23 months. It contains 50 mg of ibuprofen per 1.25 mL and serves as a pain reliever and fever reducer. This medication can help reduce fever and relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

EQUALINE is formulated as a concentrated drop that lasts up to 8 hours and is available in a pleasant berry flavor. It is dye-free, does not contain high fructose corn syrup, and is non-staining, making it a suitable option for young children.

Uses

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

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

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adult use. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use. You can find the right dose by referring to the dosing chart, which is based on your child's weight. If possible, use their weight for dosing; if not, you can use their age instead.

When measuring the dose, use the dosing device that comes with the product, as other devices may not provide accurate measurements. For administration, slowly dispense the liquid into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. For infants under 6 months, it's best to consult a doctor before giving any medication. For children weighing between 12 to 17 pounds (6 to 11 months old), the dose is 1.25 mL, and for those weighing 18 to 23 pounds (12 to 23 months old), the dose is 1.875 mL.

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.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe sore throat symptoms, stomach pain, or any signs of heart problems or stroke, such as chest pain or weakness on one side of the body, seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially 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 issues, 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 symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, consult a doctor. In case of an overdose, seek 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 be cautious with medications. The use of ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby. Specifically, using ibuprofen can lead to complications such as the premature closure of a vital blood vessel in the fetus, known as the ductus arteriosus.

Before taking ibuprofen at any stage of your pregnancy, you should consult your healthcare provider. They can help determine if any dosage adjustments are necessary and guide you on safe alternatives. Always prioritize your health and your baby's well-being by seeking professional advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could pose risks to your infant. Therefore, exercising caution is essential when considering this medication while nursing. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 6 months to 23 months, the dosage varies based on their weight. For example, if your child weighs between 12-17 pounds (6-11 months), the recommended dose is 1.25 mL, and for those weighing 18-23 pounds (12-23 months), it’s 1.875 mL. Always consult a doctor if your child has a history of allergic reactions to pain relievers, stomach issues, or if they have not been drinking enough fluids due to vomiting or diarrhea.

Additionally, it's important to seek medical advice if your child has high blood pressure, heart disease, liver or kidney problems, asthma, or is taking certain medications like diuretics. If your child shows any signs of serious side effects, such as stomach bleeding (like vomiting blood or having black stools) or symptoms of heart problems or stroke (like chest pain or weakness), stop using the medication and contact a doctor immediately. If your child does not feel better within 24 hours, you should also reach out to a healthcare professional.

Geriatric Use

You can feel reassured that there are no specific concerns regarding the use of EQUALINE IBUPROFEN for older adults. The information available does not indicate any need for dosage adjustments or special safety precautions for elderly patients. This means that, generally, you can use this medication as directed without additional worries about its effects on older adults. However, it's always a good idea to consult with a healthcare provider about any medications you or your loved ones are taking, especially if there are other health conditions involved.

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 doctor can help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

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 crucial to ensure that the medication is safe and effective for you.

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

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 severe allergic reactions. Additionally, if your child is on blood thinners or steroid medications, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

If your child is using a diuretic (a type of medication that helps remove excess fluid), it's crucial to consult with a healthcare provider before giving ibuprofen. Furthermore, using NSAIDs, except for aspirin, can raise the chances of serious heart issues, such as heart attack or stroke, especially if taken in higher doses or for extended periods. Always discuss any medications or tests with your healthcare provider to ensure safety and effectiveness.

Storage and Handling

To ensure the safety and effectiveness 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 the printed neckband; do not use the product if it is broken or missing, as this could indicate a safety issue.

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

Additional Information

You should take this medication orally, dispensing the liquid slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day.

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

FAQ

What is EQUALINE?

EQUALINE is an infants’ ibuprofen oral suspension that contains 50mg of ibuprofen per 1.25mL, suitable for children aged 6 months to 23 months.

What does EQUALINE do?

EQUALINE acts as a pain reliever and fever reducer, helping to reduce fever and relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headaches, and toothaches.

How should I administer EQUALINE?

Use the enclosed syringe to measure the dose accurately. Dispense the liquid slowly into the child’s mouth, toward the inner cheek, and shake well before use.

What is the dosing chart for EQUALINE?

For children weighing 12-17 lbs (6-11 months), the dose is 1.25 mL. For those weighing 18-23 lbs (12-23 months), the dose is 1.875 mL. Consult a doctor for children under 6 months.

Are there any warnings associated with EQUALINE?

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

What should I do if my child experiences side effects?

Stop using EQUALINE and consult a doctor if your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours.

Is EQUALINE safe to use during pregnancy?

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

Can nursing mothers use EQUALINE?

Nursing mothers should consult a doctor before using EQUALINE, as there is a potential for ibuprofen to be excreted in breast milk.

How should EQUALINE be stored?

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® is an oral suspension formulation of ibuprofen designed for infants aged 6 months to 23 months. Each 1.25 mL dose contains 50 mg of ibuprofen, providing effective pain relief and fever reduction as a nonsteroidal anti-inflammatory drug (NSAID). The product is presented in a concentrated drop form, with a total volume of 1 fluid ounce (30 mL). EQUALINE® is dye-free, non-staining, and free from high fructose corn syrup, featuring a berry flavor for palatability. The formulation is designed to last up to 8 hours and is intended for use only with the enclosed syringe.

Uses and Indications

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

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

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should ensure that the appropriate dosing is followed as outlined below.

Prior to administration, the product must be shaken well. The dosing should be determined using the chart provided, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference.

The following dosing chart should be utilized:

  • For infants under 6 months of age (weight under 6 lbs), consultation with a physician is required before administration.

  • For infants weighing between 12-17 lbs (ages 6-11 months), the recommended dose is 1.25 mL.

  • For infants weighing between 18-23 lbs (ages 12-23 months), the recommended dose is 1.875 mL.

It is imperative to measure the dose using the dosing device provided; no other measuring devices should be used to ensure accuracy. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek to facilitate swallowing.

If additional doses are necessary, they may be repeated every 6 to 8 hours, but it is crucial not to exceed 4 doses in a 24-hour period. Healthcare professionals should advise caregivers to adhere strictly to these guidelines and not exceed 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 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 include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

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

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

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

Patients should be instructed to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention should be sought, or contact should be made with a Poison Control Center 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 warning for severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin, ibuprofen, or naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in higher doses or for extended periods.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation. It is advised not to use the product for more than two days or to administer it to children under three years of age without a doctor's direction.

Patients should discontinue use and seek medical advice if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also necessitate immediate medical attention. Furthermore, if there is no 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 new symptoms should also prompt a discussion with a healthcare provider.

Before using this product, it is essential for patients to consult a doctor if any of the following apply: a history of stomach problems, such as heartburn; previous serious side effects from pain relievers or fever reducers; dehydration due to vomiting or diarrhea; or pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use. Additionally, consultation with a doctor or pharmacist is advised for patients under medical care for any serious condition 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 in individuals with a known allergy to aspirin. It is crucial to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. This risk is also heightened 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.

Diuretics Ibuprofen may interact with diuretics, potentially diminishing their effectiveness. It is advisable to consult a healthcare provider if the patient is concurrently taking a diuretic to evaluate the need for dosage adjustments or alternative therapies.

Cardiovascular Risks The use of NSAIDs, excluding aspirin, is associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used beyond the recommended duration or dosage. Patients should be monitored closely for cardiovascular symptoms, especially if ibuprofen is prescribed for extended periods.

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, a weight and age chart is provided: infants under 6 months should consult a doctor before use; for those weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL; and for those weighing 18-23 lbs (12-23 months), the recommended dose is 1.875 mL.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, a consultation is warranted if the child has a history of stomach problems, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers.

It is also important to seek medical advice if the child has not been adequately hydrated or has lost significant fluids due to vomiting or diarrhea. Children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma should be evaluated by a doctor before using this medication. Furthermore, children taking diuretics or under medical care for any serious condition should also consult a healthcare professional.

Parents or guardians should discontinue use and seek medical attention if the child exhibits signs of stomach bleeding (e.g., feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain) or symptoms indicative of heart problems or stroke (e.g., chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling). If the child does not experience relief within the first 24 hours of treatment, a doctor should be consulted.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for EQUALINE IBUPROFEN. Therefore, standard dosing guidelines may be applied to this population without modification. However, as with all medications, healthcare providers should exercise caution and monitor for any potential adverse effects, particularly in patients who may have multiple comorbidities or be taking other medications. Regular assessment of the patient's response to treatment is recommended to ensure safety and efficacy.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, particularly in the third trimester. There is a potential risk to the fetus associated with ibuprofen use during pregnancy, including complications such as premature closure of the ductus arteriosus. Due to these safety concerns, pregnant women should avoid using ibuprofen unless specifically directed by a healthcare professional.

Dosage modifications may be necessary, and it is advised that pregnant patients consult their healthcare provider before using ibuprofen to ensure appropriate management and minimize risks to fetal outcomes.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering to nursing mothers due to the potential risk to the infant.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications and may require more frequent clinical assessments to monitor for any signs of hepatic decompensation. It is crucial to tailor treatment plans based on the severity of hepatic impairment to optimize outcomes while minimizing risks.

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. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical data. Additionally, there is no information regarding animal pharmacology and toxicology. The insert does not provide any details on nonclinical toxicology, including carcinogenicity or mutagenicity.

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 discuss the use of this medication 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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial to ensure the product's quality and effectiveness.

Additional Clinical Information

The medication is administered orally, with clinicians advised to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. If necessary, the dose may be repeated every 6 to 8 hours, but it should not exceed four doses in a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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

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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.