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Signature Care Childrens Ibuprofen

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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 2015
Label revision date
December 9, 2017
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 2015
Label revision date
December 9, 2017
Manufacturer
Safeway
Registration number
ANDA074937
NDC root
21130-035
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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. It comes in a pleasant berry flavor and is free from dyes, alcohol, and gluten. This medication serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it effectively reduces fever and can provide relief for 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 is 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.

Dosage and Administration

Before using this product, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use. You can find the right dose by referring 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 a 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 under 24 pounds (under 2 years), consult a doctor before giving any dose. For children weighing between 24 and 95 pounds, refer to the chart for the appropriate amount to give.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Dependence (a condition where the body becomes reliant on a substance) can also occur, so it's crucial to follow these guidelines closely to ensure your child's safety.

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 fatal, particularly if used in higher doses or for longer than recommended. If your child experiences severe sore throat symptoms, stomach pain, or any signs of heart problems, such as chest pain or difficulty breathing, seek medical attention immediately. Always consult a doctor before using ibuprofen if your child has a history of stomach issues, dehydration, or other serious health conditions.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, consult a doctor. In case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always err on the side of caution and reach out for help if you think an overdose has occurred.

Pregnancy Use

It’s important to be cautious about using ibuprofen during pregnancy, as its safety has not been established. Specifically, ibuprofen is not recommended during pregnancy, especially in the third trimester, due to potential risks to the fetus, including possible cardiovascular effects.

If you are pregnant or planning to become pregnant, it’s essential to consult your healthcare provider before taking ibuprofen or any medication. They can help you understand the risks and explore safer alternatives for managing pain or inflammation during this time.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

You should avoid using this medication in children under 3 years of age unless a doctor specifically advises it. For children aged 2 to 11 years, the dosage depends on their weight. For example, if your child weighs under 24 pounds, you should consult a doctor for guidance. For those weighing 24-35 pounds (ages 2-3), the recommended dose is 5 mL, while children weighing 36-47 pounds (ages 4-5) should take 7.5 mL. The doses increase with weight, reaching 15 mL for children weighing 72-95 pounds (age 11).

It's important to keep this medication out of reach of children and to seek medical help immediately in case of an overdose. If your child has not been drinking fluids, has lost a lot of fluid from vomiting or diarrhea, or has a history of stomach issues, heart problems, or other serious health conditions, consult a doctor before use. Additionally, if your child does not feel better within 24 hours or if symptoms worsen, you should also reach out to a healthcare professional.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily indicated for children aged 2 to 11 years. This means that there are no dosage adjustments or safety concerns specifically noted for elderly patients.

If you are caring for an older adult, it's always a good idea to consult with a healthcare professional before starting any new medication, even if there are no specific warnings or adjustments mentioned. This ensures that the treatment is safe and appropriate for their individual health needs.

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 (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 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 use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

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

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 4 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 pain reliever and fever reducer for children ages 2 to 11 years, available in a berry flavor.

What are the indications for using Children's Ibuprofen?

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

How should I dose Children's Ibuprofen?

Dosing is based on weight; for example, children weighing 24-35 lbs should take 5 mL. Always refer to the dosing chart and consult a doctor if unsure.

What precautions should I take before using Children's Ibuprofen?

Consult a doctor if your child has a history of stomach problems, high blood pressure, heart disease, or is taking other medications.

What should I do if my child experiences side effects?

Stop use and seek medical help if your child shows signs of a severe allergic reaction, stomach bleeding, or symptoms of heart problems.

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

No, do not give Children's Ibuprofen to children under 2 years old unless directed by a doctor.

Is it safe to use Children's Ibuprofen during pregnancy?

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

How should I store Children's Ibuprofen?

Store it at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Signature Care Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Signature Care 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 as 100 mg per 5 mL. This non-steroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer. The product is presented in a berry flavor and is free from dyes, alcohol, and gluten. It is designed to provide relief lasting up to 8 hours and is non-staining. Each bottle contains 4 fluid ounces (118 mL) of the suspension.

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 to ensure proper mixing.

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 should be performed using only the enclosed dosing cup to ensure accuracy; other dosing devices are not recommended. If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed four doses. After each use, the dosing cup should be washed thoroughly to maintain hygiene.

To ensure child safety, the original bottle cap must be replaced after each use to maintain its child-resistant properties. It is crucial to adhere strictly to the recommended dosages and not exceed the directed amount.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

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

The use of ibuprofen, an NSAID, carries a risk of severe stomach bleeding. This risk is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

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

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. Ibuprofen should not be used for more than two days in the case of sore throat, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

Healthcare providers should advise caregivers to discontinue use and seek medical attention 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 suggestive 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, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

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. The likelihood of these serious cardiovascular events is greater when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients should seek medical attention if they experience severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised not to use the product for more than two days or to administer it to children under three years of age without a doctor's guidance.

Common adverse reactions may include gastrointestinal discomfort, and patients should be advised to consult a healthcare professional 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.

Before using this product, it is important for patients to consult a healthcare provider if they have a history of stomach problems, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients under a doctor's care for serious conditions or those taking other medications should seek advice 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, particularly in individuals with a known allergy to aspirin. Caution is advised when prescribing ibuprofen to patients with such allergies.

  • Increased Risk of Gastrointestinal Bleeding: The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. This risk is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. It is recommended that healthcare providers monitor patients closely for signs of gastrointestinal complications when these medications are used together.

Pharmacokinetic Interactions:

No specific laboratory test interactions have been identified in the available data. Therefore, routine laboratory monitoring is not indicated based on the current information.

Packaging & NDC

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

Packaging configurations for Signature Care 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 follows:

  • 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

Doses may be repeated every 6-8 hours, not exceeding 4 doses in a 24-hour period. It is essential to keep the medication out of reach of children.

Healthcare professionals should advise parents to consult a doctor if the child has not been drinking fluids or has lost significant fluid due to vomiting or diarrhea. Additional caution is warranted for children with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Children with asthma or those taking diuretics or under care for serious conditions should also be evaluated by a doctor before use.

Signs of potential complications, such as stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), or symptoms indicative of heart problems or stroke (e.g., chest pain, trouble breathing, weakness on one side of the body, slurred speech, leg swelling) necessitate immediate medical consultation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a doctor should be consulted. In case of overdose, medical help or contact with a Poison Control Center is imperative.

Geriatric Use

Elderly patients have not been specifically studied in relation to the use of this product, and no specific information regarding geriatric use is provided in the prescribing information. The product is indicated for pediatric patients aged 2 to 11 years, and there are no dosage adjustments or safety concerns mentioned for elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the lack of data on its safety and efficacy in this population. Monitoring for any potential adverse effects is advisable, given the absence of specific guidelines for elderly patients.

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 pregnancy may pose risks, including potential cardiovascular effects on the developing fetus. Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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. 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 liver enzymes and other relevant laboratory parameters is advised to ensure patient safety and therapeutic efficacy. If any signs of liver dysfunction arise during treatment, appropriate modifications to the therapeutic regimen should be considered.

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 help can significantly influence outcomes. Symptoms of overdose 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, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has 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. It is recommended to administer the medication with food or milk if the child experiences stomach upset.

Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, healthcare providers should inform patients to stop use and seek medical attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should be made aware that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should consult a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a discussion with a doctor.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if any of the following conditions apply: the child has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients should be advised to discuss the use of this medication if the child has asthma or is taking a diuretic.

Finally, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is currently under medical care for any serious condition or is taking any other medications.

Storage and Handling

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

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

Additional Clinical Information

Patients should be informed that the medication is administered orally, with the option to repeat doses every 6-8 hours as needed, not exceeding four doses in a 24-hour period. It is recommended to take the medication with food or milk if stomach upset occurs.

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. Patients should use only the enclosed dosing cup for administration and ensure it is washed after each use.

Drug Information (PDF)

This file contains official product information for Signature Care 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 Signature Care 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

Last AI update:

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.