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Childrens Ibuprofen Oral Suspension

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Active ingredient
Ibuprofen 100 mg/10 mL – 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 1999
Label revision date
August 31, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/10 mL – 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 1999
Label revision date
August 31, 2022
Manufacturer
Pharmaceutical Associates, Inc.
Registration number
ANDA074916
NDC roots
0121-0914, 0121-1828
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

Children's Ibuprofen Oral Suspension is a medication designed to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It also helps reduce fever. This product is a nonsteroidal anti-inflammatory drug (NSAID) that comes in a grape flavor and is alcohol-free, making it suitable for children. Each 5 mL dose contains 100 mg of ibuprofen, providing effective relief for your child's discomfort.

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 product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to shake the bottle well before each use. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If you need to repeat the dose, you can do so every 6 to 8 hours, but remember not to exceed four doses in a single day.

Here’s a quick guide to help you determine the correct amount: For children under 2 years old or weighing less than 24 pounds, consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 to 35 pounds, the dose is 5 mL. If your child is 4 to 5 years old and weighs between 36 to 47 pounds, the dose increases to 7.5 mL. For those aged 6 to 8 years and weighing 48 to 59 pounds, the dose is 10 mL. Children aged 9 to 10 years who weigh between 60 to 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 these guidelines or consult your doctor for any specific instructions.

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 heart surgery, as this could pose serious risks. Always consult with a healthcare professional if you have any concerns or questions about using this medication for your child.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe allergy may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries risks 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 symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always check with a healthcare professional before giving ibuprofen if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using it immediately and seek medical help. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that may lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs. Be aware that using NSAIDs can also increase the risk of heart attack and stroke, especially if taken in higher doses or for longer than recommended.

Before giving ibuprofen to your child, consult a doctor if they have any history of stomach issues, dehydration, high blood pressure, or asthma. It's also important to check with a healthcare professional if your child is on any other medications or has a serious medical condition. If your child experiences symptoms like faintness, vomiting blood, or chest pain, stop the medication and contact a doctor right away. For any overdose situation, seek immediate medical assistance or call Poison Control at 1-800-222-1222.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen during pregnancy has not been established. In fact, using ibuprofen, especially in the third trimester, is not recommended because it can harm the developing fetus. Research suggests that taking nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen during pregnancy may increase the risk of miscarriage and can lead to issues such as fetal kidney problems.

Before considering ibuprofen, you should always consult your healthcare provider, particularly if you are in the later stages of your pregnancy. They can help you understand the risks and explore safer alternatives for managing pain or inflammation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not give it to children under 2 years old unless a doctor specifically advises you to do so. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4 to 5 years (36-47 lbs), 10 mL for ages 6 to 8 years (48-59 lbs), 12.5 mL for ages 9 to 10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs).

Whenever possible, use your child's weight to determine the dose; if that's not feasible, you can use their age. Make sure not to exceed 4 doses in a day, and consult a doctor if your child has a history of stomach issues, is taking other medications, or isn't drinking enough fluids. Additionally, do not use this medication for more than 2 days, especially in children under 3 years, if they have a severe or persistent sore throat, or if they also have a high fever, headache, nausea, or vomiting.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it's important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor 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 doctor will help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your health and safety. Always prioritize open communication with your healthcare provider regarding your kidney health.

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) to ensure your safety and the effectiveness of your treatment.

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

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious health issues. For example, taking ibuprofen, a common pain reliever, alongside blood thinners (medications that prevent blood clots) or steroids can significantly increase the risk of severe stomach bleeding. Additionally, using nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, may raise your chances of experiencing heart attack, heart failure, or stroke, especially if you take them more than recommended or for an extended period.

If your child is on any other medications, it's crucial to consult with a healthcare provider. They can help identify any possible interactions and ensure that your child's treatment is safe and effective. Always discuss your medications and any lab tests with your doctor to avoid unexpected complications.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20 to 25°C (68 to 77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

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. If you experience stomach upset, it's advisable to take the medication with food or milk.

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen Oral Suspension used for?

Children's Ibuprofen Oral Suspension is used to relieve minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

How should I dose Children's Ibuprofen Oral Suspension?

You should find the right dose on the dosing chart based on your child's weight or age. Do not exceed 4 doses in a day and repeat every 6-8 hours if needed.

What should I do before giving this medication to my child?

Shake well before using and consult a doctor if your child has a history of stomach problems, is taking other medications, or has not been drinking fluids.

Are there any serious side effects I should be aware of?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Seek medical help if your child experiences symptoms like fainting, vomiting blood, or chest pain.

Can I give Children's Ibuprofen to my child if they are under 2 years old?

Do not give this medication to children under 2 years of age unless directed by a doctor.

Is it safe to use ibuprofen during pregnancy?

Safety during pregnancy has not been established, and ibuprofen is contraindicated, especially in the third trimester due to potential risks to the fetus.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen Oral Suspension?

Store the medication between 20 to 25°C (68 to 77°F) and keep it out of reach of children.

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, USP is a nonsteroidal anti-inflammatory drug (NSAID) formulated to provide pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen. The product is grape-flavored and alcohol-free, designed for pediatric use. It is packaged in a non-child-resistant container and is manufactured by Pharmaceutical Associates, Inc., located in Greenville, SC 29680. The National Drug Code (NDC) for this formulation is 0121-0914-05. Users are advised to shake well before use.

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.

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

Dosing may be repeated every 6 to 8 hours as needed, but it is crucial not to exceed 4 doses in a 24-hour period. Healthcare professionals should ensure that the total daily dosage does not exceed the recommended limits.

Contraindications

Use is contraindicated in the following situations:

Patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer should not use this product, as it may trigger severe allergic responses. Additionally, the product is contraindicated for use immediately before or after heart surgery due to potential complications associated with its effects on cardiovascular function.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions 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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries the risk of severe gastrointestinal bleeding. This risk is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), or those exceeding the recommended dosage or duration of treatment. Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher-than-recommended dosages.

Healthcare professionals should be vigilant for severe or persistent sore throat symptoms, particularly when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical evaluation. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age without a physician's directive.

Before prescribing or recommending ibuprofen, it is essential to consult a physician if any of the following conditions apply to the child: a history of stomach bleeding, previous gastrointestinal issues such as heartburn, adverse reactions to pain relievers or fever reducers, inadequate fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Additionally, consultation is advised if the child is on diuretics or 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 the Poison Control Center (1-800-222-1222) should be contacted.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any signs of gastrointestinal bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms suggestive of cardiovascular issues 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 consultation is necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this NSAID-containing 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 carries a warning for severe stomach bleeding, which is more likely to occur in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. The risk of stomach bleeding is also heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess of the directed dosage or for longer than recommended.

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. It is advised to discontinue use and consult a healthcare provider if any of the following symptoms occur: feeling faint, vomiting blood, passing bloody or black stools, experiencing unrelenting stomach pain, chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

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, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms also warrants consultation with a healthcare professional.

Before using this product, it is essential for patients to consult a doctor 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. Patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical advice prior to use. Additionally, patients with asthma or those taking diuretics should consult a healthcare provider before administration.

Drug Interactions

Ibuprofen has been associated with significant drug interactions that warrant careful consideration, particularly regarding its use with anticoagulants and steroids.

When administered concurrently with blood-thinning agents (anticoagulants) or steroid medications, ibuprofen may increase the risk of severe gastrointestinal bleeding. Therefore, it is advisable to monitor patients closely for signs of gastrointestinal distress and to consider alternative pain management strategies when these medications are used together.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, has been linked to an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. Clinicians should evaluate the necessity of NSAID therapy in patients with existing cardiovascular conditions and consider dosage adjustments or alternative therapies as appropriate.

For pediatric patients, it is essential to consult a healthcare provider if the child is taking any other medications, as potential drug interactions may occur. Monitoring and dosage adjustments may be necessary based on the specific medications involved.

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 under 2 years of age should not be given this medication unless directed by a doctor. For children aged 2-3 years (24-35 lbs), the recommended dose is 5 mL. For those aged 4-5 years (36-47 lbs), the recommended dose increases to 7.5 mL. Children aged 6-8 years (48-59 lbs) should receive 10 mL, while those aged 9-10 years (60-71 lbs) are recommended to take 12.5 mL. For children aged 11 years (72-95 lbs), the appropriate dose is 15 mL.

When determining the dose, it is preferable to use the child's weight; if weight is not available, age may be used as a guide. The medication should not be administered more than 4 times a day.

Healthcare professionals should exercise caution and consult a doctor if the child has a history of stomach problems, is taking other medications, or has not been adequately hydrated. Additionally, the medication should not be used for more than 2 days or given to children under 3 years of age unless directed by a doctor if the sore throat is severe or persistent, or accompanied by high fever, headache, nausea, or vomiting.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Safety during pregnancy has not been established for ibuprofen. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with an increased risk of miscarriage, fetal renal impairment, and other adverse effects. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm.

Pregnant women are advised to consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy. It is essential for healthcare professionals to weigh the potential risks against the benefits when considering the use of ibuprofen in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available about the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

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 cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach and monitoring requirements.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis. Additionally, cases of serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented.

Cardiovascular events, including myocardial infarction and stroke, have also been reported in association with ibuprofen use. Furthermore, liver enzyme elevations have been observed in some patients. There have been instances of asthma exacerbations noted in individuals with a prior history of asthma.

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 if they experience stomach upset, the medication can be taken with food or milk to alleviate discomfort. 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 there is a stomach bleeding warning applicable to the child.

Healthcare providers should encourage patients to discuss any previous serious side effects or problems the child may have experienced from taking pain relievers or fever reducers. Additionally, patients should be advised to consult a doctor before use if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea.

Patients should also be reminded to seek medical advice before use if the child has any of the following conditions: high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Furthermore, it is important to ask a doctor before use if the child is taking a diuretic or if the child is under a doctor's care for any serious condition. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if the child is taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20 to 25°C (68 to 77°F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any conditions that may compromise the integrity 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. Patients are advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel 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 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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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.