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Childrens Motrin

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2001
Label revision date
November 1, 2024
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 2001
Label revision date
November 1, 2024
Manufacturer
Kenvue Brands LLC
Registration number
NDA020516
NDC root
50580-184
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Children's Motrin® is an oral suspension that contains ibuprofen, a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed for children aged 2 to 11 years and is available in a dye-free, alcohol-free formula with a pleasant original berry flavor.

This medication is primarily used to relieve minor aches and pains associated with common conditions such as the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

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. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to follow the dosing instructions carefully. You should find the right dose by referring to the dosing chart, which considers both weight and age. If possible, use your child's weight to determine the correct amount; if not, you can use their age instead. Always use the enclosed dosing cup to measure the dose accurately—do not use any other device.

For most situations, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. If your child weighs under 24 pounds or is under 2 years old, it's best to consult a doctor for the appropriate dose. For children weighing between 24 and 95 pounds, the chart provides specific milliliter (mL) doses based on their weight and age. Always ensure you do not give more than the recommended amount.

What to Avoid

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. 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 signs of heart problems (like chest pain or trouble breathing), seek medical attention immediately. It's important to consult a doctor before using ibuprofen if your child has any underlying health issues 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 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, stop use and contact your doctor right away.

If you or your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always consult your doctor if symptoms worsen or new symptoms appear.

Overdose

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

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

Pregnancy Use

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

Before taking any medication, including ibuprofen, you should consult your healthcare provider. They can help you understand the potential risks and guide you toward safer alternatives if needed. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during 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 on your nursing infant have not been thoroughly studied. Because of this uncertainty, it’s wise to be cautious.

While you are taking ibuprofen, 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 the safety of both you and your child.

Pediatric Use

When giving this medication to children, it's important to follow specific dosing guidelines based on their weight and age. For children under 2 years old and weighing less than 24 pounds, you should consult a doctor before use. For those aged 2-3 years and weighing between 24-35 pounds, the dose is 5 mL. As children grow, the dosage increases: 7.5 mL for ages 4-5 years (36-47 lbs), 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs).

Be cautious not to use this medication for more than 2 days or for children under 3 years without a doctor's guidance. If your child has a history of stomach issues, dehydration, or certain health conditions like high blood pressure or asthma, consult a doctor before administering the medication. Always use the enclosed dosing cup for accurate measurement and do not exceed 4 doses in a day, with doses spaced 6-8 hours apart.

Geriatric Use

While there is no specific information about the use of Children's Motrin (ibuprofen suspension) in older adults, it's important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this medication. They can provide guidance tailored to your individual health needs, especially if you have any existing health conditions or are taking other medications. Always prioritize safety and ensure that any medication you take is appropriate for your age and health status.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

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 your child is taking ibuprofen. If your child is allergic to aspirin, they may experience a severe allergic reaction to ibuprofen. Additionally, the risk of stomach bleeding increases if they are also taking blood thinners (medications that prevent blood clots) or steroids, as well as other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

Before giving ibuprofen to your child, it's crucial to consult with a healthcare provider, especially if they are on a diuretic (a medication that helps remove excess fluid from the body) or any other medications. Always check with a doctor or pharmacist to ensure that ibuprofen is safe to use alongside any other drugs your child may be taking.

Storage and Handling

To ensure the best performance and safety 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 tape or bottle wrap marked "SAFETY SEAL®" is broken or missing. This helps to guarantee that the product remains uncontaminated and effective for your needs. Always handle the product with care to maintain its integrity and safety.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. It's important to keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Motrin®?

Children's Motrin® is an oral suspension containing ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), designed for children aged 2 to 11 years.

What does Children's Motrin® do?

It relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and reduces fever.

How should I dose Children's Motrin®?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight and age. Do not exceed 4 doses in a day.

What are the side effects of Children's Motrin®?

Possible side effects include severe allergic reactions, stomach bleeding, and increased risk of heart attack or stroke. Consult a doctor if any severe symptoms occur.

Can I use Children's Motrin® if my child has allergies?

Do not use if your child has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

Is it safe to use Children's Motrin® during pregnancy?

Safety during pregnancy has not been established, and ibuprofen is contraindicated, especially in the third trimester.

What should I do if my child experiences 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 Children's Motrin®?

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

Can I give Children's Motrin® to my child if they have a history of stomach problems?

Consult a doctor before use if your child has a history of stomach problems, such as ulcers or bleeding.

What should I do if my child's symptoms do not improve?

If your child does not get relief within 24 hours, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

Packaging Info

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

Packaging configurations for Childrens Motrin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Motrin® is an oral suspension formulation containing ibuprofen, indicated for use in children aged 2 to 11 years. Each 5 mL dose delivers 100 mg of ibuprofen, functioning as a nonsteroidal anti-inflammatory drug (NSAID) for the relief of pain and reduction of fever. The product is dye-free, alcohol-free, and non-staining, with a pleasant original berry flavor. The suspension is packaged in a 4 fl oz (120 mL) bottle and provides relief that lasts up to 8 hours. The National Drug Code (NDC) for this product is 50580-184-50.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, flu, sore throat, headache, and toothache. Additionally, it is effective in reducing 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. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

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

Dosing may be repeated every 6-8 hours as needed, but it is crucial not to exceed 4 doses in a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger severe allergic responses. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

Warnings and Precautions

Ibuprofen may cause 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 is associated with a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or prolonged use beyond the recommended guidelines.

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate consultation with a healthcare provider is advised. Ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a physician.

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

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—medical attention should be sought without delay.

Furthermore, 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 redness or swelling occurs in the affected area, or if any new symptoms develop, it is essential to seek medical advice.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen. 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 ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential 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. It is crucial for patients to adhere to the recommended dosage and duration of treatment to minimize this risk.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or exceeding the recommended dosage.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting, and should seek medical attention promptly. Parents should discontinue use and consult a healthcare provider if their child exhibits symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation.

It is advised that ibuprofen not be used if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, or immediately before or after heart surgery. Prior to use, consultation with a healthcare provider is recommended if the child has a history of stomach issues, is dehydrated, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has experienced a stroke. Special caution should be exercised in children with asthma or those taking diuretics.

Patients should also seek medical advice if the child does not achieve relief within the first 24 hours of treatment, 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.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is crucial to assess the patient's allergy history before administration.

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

Diuretics Patients taking diuretics should consult a healthcare provider prior to using ibuprofen, as potential interactions may necessitate dosage adjustments or increased monitoring.

General Recommendations It is advisable for patients to seek guidance from a healthcare professional or pharmacist before using ibuprofen in conjunction with any other medications. This precaution helps ensure safe and effective use while minimizing the risk of adverse interactions.

Packaging & NDC

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

Packaging configurations for Childrens Motrin.
Details

Pediatric Use

Pediatric patients require careful consideration when administering this medication. The dosing recommendations are as follows:

  • For patients under 24 lb and under 2 years of age, a healthcare professional should be consulted for appropriate dosing.

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

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

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

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

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

It is important to note specific warnings for pediatric use. The medication should not be used for more than 2 days or administered to children under 3 years of age unless directed by a healthcare professional. Caution is advised in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants, steroids, or other NSAIDs. Consultation with a healthcare provider is recommended if the child has a history of stomach issues, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke, or asthma.

For administration, only the enclosed dosing cup should be used; other dosing devices are not recommended. If necessary, doses may be repeated every 6-8 hours, but the total should not exceed 4 doses in a 24-hour period.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Children's Motrin (ibuprofen suspension). As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, particularly in the absence of detailed clinical findings related to this population.

It is advisable for healthcare providers to monitor elderly patients closely for any potential adverse effects or changes in response to treatment, given the general considerations for increased sensitivity to medications in this age group.

Pregnancy

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

Women of childbearing potential should consult a healthcare provider before using ibuprofen if they are pregnant or planning to become pregnant. It is essential to weigh the potential risks against the benefits of treatment in this population.

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. It is recommended to monitor the nursing infant for any adverse effects if the mother is taking 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 to ensure safety and efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects effectively.

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 the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients with a history of stomach ulcers or bleeding problems, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been noted as serious conditions that require prompt medical consultation.

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.

Patients should be informed 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, it is important to emphasize that this medication should not be administered right before or after heart surgery.

Healthcare providers should counsel patients 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. Furthermore, patients should be advised 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 also be informed to stop 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 affected area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is essential for patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies. Additionally, patients should be encouraged to seek medical advice if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea.

Healthcare providers should also recommend consulting a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients should be advised to seek medical guidance if the child has asthma, is taking a diuretic, or is under a doctor's care for any serious condition. Lastly, it is important for patients to consult a doctor or pharmacist before use if the child is taking any other medications.

Storage and Handling

The product is supplied in a secure carton that must remain unopened until use. It is essential to inspect the carton for any signs of tampering; do not use the product if the carton is opened or if the carton tape or bottle wrap imprinted with "SAFETY SEAL®" is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

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.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Motrin, 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 Motrin, 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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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.