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Sound Body Childrens Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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 2016
Label revision date
November 29, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
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 2016
Label revision date
November 29, 2017
Manufacturer
Big Lots Stores, Inc.
Registration number
ANDA074937
NDC root
50594-018
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

CHILDREN’S Ibuprofen is an oral suspension designed for children aged 2 to 11 years, providing effective relief from minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. As a nonsteroidal anti-inflammatory drug (NSAID), it also works to reduce fever, helping your child feel more comfortable when they are unwell.

This medication comes in a pleasant berry flavor and is alcohol-free, making it a suitable option for young children. Each dose contains 100 mg of ibuprofen per 5 mL, and its effects can last up to 8 hours, providing extended relief when needed.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus if taken during pregnancy.

Dosage and Administration

Before using this medication, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the dosage instructions carefully and never exceed the recommended amount. Start by shaking the bottle well before each use. To find the right dose, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age instead.

Make sure to use only the enclosed dosing cup for measuring the medication, as other devices may not provide accurate measurements. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times in a single day. After each use, wash the dosing cup to keep it clean, and always replace the original bottle cap to ensure it remains child-resistant. For children weighing under 24 pounds (under 2 years), consult a doctor before administering any dose.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

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 or persistent sore throat, high fever, or symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), or shows signs of heart problems (like chest pain or trouble breathing), seek medical attention immediately. Always consult a doctor if your child has any underlying health conditions or is taking other medications before using ibuprofen.

Warnings and Precautions

It's important to be aware of some serious warnings when using this medication. If you or your child have a known allergy to aspirin, be cautious, as this medication can cause severe allergic reactions, including hives, facial swelling, and difficulty breathing. If any of these symptoms occur, stop using the medication and seek medical help immediately. Additionally, this medication can increase the risk of stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or ibuprofen.

You should also be mindful of the potential for heart problems, as using this medication can increase the risk of heart attack and stroke, particularly if used in higher doses or for longer than recommended. If your child has a severe sore throat that lasts more than two days or is accompanied by a high fever, headache, nausea, or vomiting, consult a doctor right away. Always check with a healthcare provider before use if your child has any underlying health conditions, is taking other medications, or has experienced side effects from pain relievers in the past.

If you suspect an overdose, contact a Poison Control Center or seek medical help immediately. Stop using the medication and call your doctor if your child experiences symptoms of stomach bleeding (like faintness, vomiting blood, or black stools), signs of heart problems or stroke (such as chest pain or weakness on one side of the body), or if their symptoms do not improve within 24 hours.

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 safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, particularly in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult with your healthcare provider to discuss any concerns and explore safer alternatives for pain relief or inflammation management during pregnancy. Your health and the health of your baby are paramount, so always seek professional advice when considering medication.

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.

If you do take ibuprofen while breastfeeding, keep an eye on your baby for any unusual reactions or side effects. Monitoring your infant can help ensure their safety while you manage your own health needs.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication in children under 3 years of age unless directed by a doctor. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, if your child weighs between 24-35 pounds and is 2-3 years old, the recommended dose is 5 mL. Always consult the dosing chart for specific amounts based on your child's weight.

Additionally, do not use this medication for more than 2 days without consulting a doctor. Keep it out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Before giving this medication, ask your doctor if your child has any serious health conditions, is taking other medications, or has a history of allergies or stomach issues.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of the treatment.

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

Drug Interactions

It's important to talk to your healthcare provider about any medications your child is taking, especially if they include ibuprofen. This is because ibuprofen can cause severe allergic reactions in those who are allergic to aspirin. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. The same goes for other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, which can also heighten this risk.

Always ensure that you discuss all medications and any potential interactions with your healthcare provider to keep your child safe and healthy.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before using, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent stomach upset, consider taking it with food or milk. Always use the enclosed dosing cup for accurate measurement, and make sure to wash it after each use.

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 Ibuprofen?

CHILDREN’S Ibuprofen is an oral suspension that contains 100 mg of ibuprofen per 5 mL, used as a pain reliever and fever reducer for children aged 2 to 11 years.

What does CHILDREN’S Ibuprofen treat?

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

How long does the effect of CHILDREN’S Ibuprofen last?

The effects can last up to 8 hours.

What is the recommended dosing for CHILDREN’S Ibuprofen?

Dosing is based on weight; 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.

Are there any contraindications for using CHILDREN’S Ibuprofen?

Do not use if the child has had an allergic reaction to ibuprofen or any other pain reliever, or if they are about to undergo heart surgery.

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or if symptoms worsen or do not improve within 24 hours.

Can CHILDREN’S Ibuprofen be used during pregnancy?

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

Is it safe to use CHILDREN’S Ibuprofen while breastfeeding?

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

What precautions should I take when using CHILDREN’S Ibuprofen?

Consult a doctor if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking other medications.

How should CHILDREN’S Ibuprofen be stored?

Store 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 Sound Body Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sound Body Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children’s Ibuprofen is an oral suspension formulated to provide pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). This product is alcohol-free and is indicated for use in children aged 2 to 11 years. The suspension is presented in a 4 FL OZ (118 mL) bottle and is flavored with berry to enhance palatability.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

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

Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use. It is imperative to adhere strictly to the recommended dosages and not exceed the directed amount.

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 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 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 problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or are exceeding the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are 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.

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 healthcare provider promptly. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless directed by a physician.

Healthcare professionals should advise caregivers to consult a doctor prior to use if any of the following conditions 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 adequately hydrated, has lost significant fluids 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. Furthermore, it is advisable to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

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.

Caregivers should be instructed to discontinue use and consult a healthcare provider 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, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, 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, medical advice should be sought without delay.

Side Effects

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

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who exceed the recommended dosage or duration of use.

Patients should also be aware of the potential for severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly if these symptoms occur.

It is advised that patients discontinue use and consult a healthcare provider if any of the following occur: the child does not achieve relief within the first 24 hours of treatment, fever or pain worsens or persists beyond three days, redness or swelling appears in the painful area, or any new symptoms arise.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is warranted for patients with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics.

Patients under a doctor's care for any serious condition or those taking other medications should also seek advice from a healthcare professional prior to use.

Drug Interactions

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

Pharmacodynamic Interactions:

  • Allergic Reactions: Ibuprofen may induce severe allergic reactions in individuals with a known allergy to aspirin. Caution is advised when prescribing ibuprofen to this population.

  • Increased Risk of Gastrointestinal Bleeding: The concomitant use of ibuprofen with anticoagulants (blood thinners) or steroid medications in pediatric patients significantly elevates the risk of stomach bleeding. Close monitoring of gastrointestinal symptoms is recommended in these cases.

  • Cumulative Risk with Other NSAIDs: The risk of gastrointestinal bleeding is also heightened when ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. It is advisable to avoid the concurrent use of multiple NSAIDs to mitigate this risk.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Sound Body Childrens Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age, as outlined in the following chart:

  • Under 24 lbs / Under 2 years: Ask a doctor

  • 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 limit use to no more than 2 days and to keep the medication out of reach of children. In the event of an overdose, medical assistance should be sought immediately, or the Poison Control Center should be contacted at 1-800-222-1222.

Before administering this medication, healthcare professionals should advise parents or guardians to consult a doctor if the child is under medical care for any serious condition, taking other medications, has a history of allergic reactions to ibuprofen or similar drugs, has gastrointestinal issues, has experienced side effects from pain relievers or fever reducers, is dehydrated, or has significant fluid loss due to vomiting or diarrhea. Additional caution is warranted for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or those taking diuretics.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

Women of childbearing potential should consult a healthcare provider before using ibuprofen if they are pregnant or planning to become pregnant to discuss the potential risks and benefits.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, or liver cirrhosis, as these 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 patient outcomes.

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 symptoms may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure safety and effectiveness of the treatment provided.

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 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 routine pharmacovigilance activities.

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.

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, 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 leg swelling, they should stop use and seek medical advice.

It is important to inform patients that if the child does not experience relief within the first 24 hours of treatment, they should stop use and consult a doctor. Furthermore, if fever or pain worsens or persists beyond three days, or if there is any redness or swelling in the affected area, medical consultation is necessary. Patients should also be advised to seek medical attention if any new symptoms arise.

When administering this product, healthcare providers should recommend giving it with food or milk to mitigate potential stomach upset.

Patients should be encouraged to consult a doctor before use if any of the following conditions apply: the child has a history of stomach bleeding, has experienced stomach problems such as heartburn, has had adverse reactions to pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids 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, healthcare providers should remind patients to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

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

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and the necessity of seeking immediate medical assistance or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients are instructed to use only the enclosed dosing cup for administration and to wash it after each use to ensure proper hygiene.

Drug Information (PDF)

This file contains official product information for Sound Body Childrens 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 Sound Body Childrens 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.