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Childrens Ibuprofen Oral Suspension

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
December 19, 2025
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
Marketed in the U.S.
Since 2020
Label revision date
December 19, 2025
Manufacturer
Marc Glassman, Inc.
Registration number
ANDA210602
NDC root
68998-320

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Drug Overview

MARC'S® Children's Ibuprofen is a pain reliever and fever reducer specifically designed for children aged 2 to 11 years. This oral suspension contains 100 mg of ibuprofen (a type of medication that helps alleviate pain and reduce fever) per 5 mL and is alcohol-free. It effectively relieves minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also helping to lower fever.

With its original berry flavor, MARC'S® Children's Ibuprofen provides a pleasant experience for children. The effects can last up to 8 hours, making it a convenient option for managing discomfort and fever in young ones.

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’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 if taken during pregnancy.

Dosage and Administration

Before you use the medication, make sure to shake the bottle well. It's important to use only the dosing cup that comes with the medication; using any other device could lead to incorrect dosing. Depending on your needs, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day.

When determining the right dose, it’s based on weight and age. For children under 2 years who weigh less than 24 pounds, you should consult a doctor for the appropriate dose. For children aged 2 to 3 years weighing between 24 and 35 pounds, the dose is 5 mL. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, the dose increases to 7.5 mL. For those aged 6 to 8 years weighing 48 to 59 pounds, the dose is 10 mL. Children aged 9 to 10 years who weigh between 60 and 71 pounds should take 12.5 mL, and for an 11-year-old weighing 72 to 95 pounds, the dose is 15 mL. Always follow your doctor’s instructions if they provide specific guidance.

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 side effects, including severe allergic reactions, especially in those allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. If you notice any of these symptoms, stop using the medication and seek medical help immediately.

Additionally, ibuprofen carries risks of stomach bleeding, heart attack, and stroke. The risk of stomach bleeding is higher if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (like aspirin or naproxen). Signs of stomach bleeding include feeling faint, vomiting blood, or having black or bloody stools. If your child experiences chest pain, trouble breathing, weakness on one side of the body, or slurred speech, seek medical attention right away. Always consult a doctor if symptoms persist or worsen, or if new symptoms appear.

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 the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience 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 emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Children's Ibuprofen Oral Suspension during pregnancy. The insert does not mention any risks or contraindications associated with taking ibuprofen while pregnant, nor does it provide any dosage modifications for pregnant individuals. Additionally, there are no special precautions outlined for using this medication during pregnancy.

As always, it's best to consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of ibuprofen on babies who are breastfed haven't been thoroughly studied, it's best to be cautious and seek professional advice to ensure the safety of both you and your child.

Pediatric Use

When considering this medication for your child aged 2 to 11 years, it's important to follow specific dosing guidelines based on their weight. For children under 24 pounds (younger than 2 years), you should consult a doctor before use. For those between 24 to 35 pounds (ages 2-3), the recommended dose is 5 mL; for 36 to 47 pounds (ages 4-5), it's 7.5 mL; for 48 to 59 pounds (ages 6-8), it's 10 mL; for 60 to 71 pounds (ages 9-10), it's 12.5 mL; and for 72 to 95 pounds (age 11), the dose is 15 mL.

It's crucial not to use this medication in children under 3 years old unless directed by a doctor. Always consult your child's doctor if they have a history of stomach issues, are taking other medications, or are not drinking enough fluids. Remember to keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily designed for children aged 2 to 11 years. This means that there are no established dosage adjustments or safety concerns specifically for elderly patients. If you are caring for an older adult, it's important to consult with a healthcare professional before starting any new medication, as they can provide guidance tailored to individual health needs and conditions. Always prioritize safety and ensure that any treatment is appropriate for the person you are caring for.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to check the packaging before use; do not use the product if the carton is opened or if the printed neckband on the bottle is broken or missing. Additionally, make sure to look at the bottom panel for the lot number and expiration date to confirm that the product is still valid for use.

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

Additional Information

No further information is available.

FAQ

What is MARC'S® Children's Ibuprofen used for?

MARC'S® Children's Ibuprofen is a pain reliever and fever reducer that relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache.

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children weighing 24-35 lbs (2-3 years) should take 5 mL, while those weighing 72-95 lbs (11 years) should take 15 mL.

How often can I give MARC'S® Children's Ibuprofen?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any warnings associated with this medication?

Yes, it may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child experiences any concerning symptoms.

Can I use MARC'S® Children's Ibuprofen if my child has had an allergic reaction to ibuprofen before?

No, do not use this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is MARC'S® Children's Ibuprofen safe for children under 2 years?

For children under 2 years, you should ask a doctor before use.

What should I do if my child experiences signs of stomach bleeding?

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and seek medical help immediately.

Can nursing mothers use MARC'S® Children's Ibuprofen?

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

How should I store MARC'S® Children's Ibuprofen?

Store it between 20-25°C (68-77°F) and do not use if the carton is opened or the bottle neckband is broken or missing.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen Oral Suspension.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Ibuprofen Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) formulated at a strength of 100 mg per 5 mL. It is presented in an original berry flavor and is alcohol-free.

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

The medication should be shaken well before use. It is imperative to utilize only the enclosed dosing cup for administration; the use of any other dosing device is not recommended.

Dosing is determined by the patient's weight and age, as outlined below:

  • For patients weighing under 24 lbs and under 2 years of age, the dose should be determined by a healthcare professional.

  • For patients weighing between 24-35 lbs and aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing between 36-47 lbs and aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing between 48-59 lbs and aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing between 60-71 lbs and aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing between 72-95 lbs and aged 11 years, the recommended dose is 15 mL.

If necessary, the dose may be repeated every 6-8 hours, but it is important not to exceed a total of 4 doses in a 24-hour period. For any uncertainties regarding dosing, consultation with a healthcare professional is advised.

Contraindications

Use is contraindicated in children 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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of an allergic reaction can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which 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.

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

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. 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 advise patients to discontinue use and seek medical attention 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 indicative 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 cases of overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

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. In the event of an allergic reaction, it is imperative to discontinue use and seek immediate medical assistance.

The use of ibuprofen carries a warning for potential severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroid medications, or other NSAIDs, including aspirin and naproxen. Patients should be advised to adhere strictly to dosing instructions, as exceeding the recommended dosage or duration of use increases the likelihood of this adverse effect.

Additionally, ibuprofen is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

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

Patients are advised to stop using ibuprofen and seek medical attention if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation.

Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare professional. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a medical consultation.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen Oral Suspension.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may be prescribed this medication, with specific dosing recommendations based on weight. For children under 24 lbs (under 2 years), consultation with a doctor is required before use. The dosing chart for children aged 2 to 11 years is as follows:

  • 24-35 lbs (2-3 years): 5 mL

  • 36-47 lbs (4-5 years): 7.5 mL

  • 48-59 lbs (6-8 years): 10 mL

  • 60-71 lbs (9-10 years): 12.5 mL

  • 72-95 lbs (11 years): 15 mL

It is important to note that this medication should not be used in children under 3 years of age unless directed by a healthcare professional. Additionally, healthcare providers should be consulted if the child has a history of stomach problems, is taking other medications, or has not been adequately hydrated.

Parents and caregivers should ensure that the medication is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Geriatric Use

Elderly patients have not been specifically studied in relation to the use of this product, and no dedicated information regarding geriatric use is provided in the prescribing information. The product is primarily intended for use in children aged 2 to 11 years.

Given the absence of data on dosage adjustments or safety considerations for elderly patients, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or complications, as the lack of specific information may indicate a need for careful evaluation on a case-by-case basis.

Pregnancy

There is no specific information available regarding the use of Children's Ibuprofen Oral Suspension during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of ibuprofen during this period. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this medication during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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

Postmarketing experience has indicated that various adverse reactions have been reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding disorders, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Serious cardiovascular events, including heart attack, heart failure, and stroke, have also been reported, with a higher incidence associated with prolonged use or doses exceeding the recommended guidelines. Furthermore, reports of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may suggest serious underlying conditions that necessitate immediate medical evaluation.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

It is essential to inform patients that this medication 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 made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If any of these symptoms occur, patients should be advised to stop use and consult a doctor.

Furthermore, patients should be informed about the symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. If these symptoms arise, patients should also stop use and seek medical attention.

Patients should be instructed 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 develop.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is also important for patients to consult a doctor before use if any of the following apply: the child has a history of stomach problems, such as heartburn; has experienced serious side effects from pain relievers or fever reducers; has not been drinking fluids; has lost significant fluid due to vomiting or diarrhea; has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke; has asthma; or is taking a diuretic.

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

Storage and Handling

The product is supplied in a carton that must remain sealed; it should not be used if the carton is opened or if the printed bottle neckband is broken or missing. For optimal preservation, the product should be stored at a temperature range of 20-25°C (68-77°F). Users are advised to check the bottom panel for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Oral Suspension, 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 Childrens Ibuprofen Oral Suspension, 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.

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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.