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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
November 30, 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
November 30, 2017
Manufacturer
Safeway
Registration number
ANDA074937
NDC root
21130-011
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

Ibuprofen is an oral suspension medication designed for children ages 2 to 11 years. It is a pain reliever and fever reducer, classified as a nonsteroidal anti-inflammatory drug (NSAID). This bubble gum-flavored liquid helps relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache, while also effectively reducing fever.

With a concentration of 100 mg per 5 mL, ibuprofen provides relief that can last up to 8 hours. It is alcohol-free and gluten-free, making it a suitable option for many children.

Uses

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

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, 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’ll find a dosing chart included, which helps you determine the right dose based on your child's weight or age. If possible, use your child's weight for the most accurate dosing.

Make sure to use only the enclosed dosing cup, as other devices may not provide the correct measurement. If your child needs another dose, you can repeat it every 6 to 8 hours, but remember not to give more than four doses 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.

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

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 attack and stroke, which can be life-threatening. This risk is heightened if the medication is 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.

In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. If your child experiences symptoms of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop using the medication and call your doctor. Also, reach out to a healthcare professional if your child shows signs of heart problems or stroke, does not find relief within 24 hours, or if any new symptoms arise.

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

The safety of ibuprofen during pregnancy has not been established, and it is generally not recommended, especially in the third trimester (the final three months of pregnancy). Using ibuprofen during this time may pose risks to your developing baby, including potential cardiovascular issues.

If you are pregnant or planning to become pregnant, it is important to consult your healthcare provider before taking ibuprofen or any medication. They can help you understand the risks and suggest safer alternatives for managing pain or inflammation during your pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the medication can be passed into your breast milk, which may pose risks to your infant. Therefore, caution is advised when considering this medication while nursing. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

When considering this medication for your child, it's important to note that it should not be used in children under 3 years of age unless specifically directed by a doctor. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, consult a doctor for guidance. For children weighing 24-35 lbs (ages 2-3), the recommended dose is 5 mL, while those weighing 36-47 lbs (ages 4-5) should receive 7.5 mL. The dosage continues to increase with weight, reaching 15 mL for an 11-year-old weighing 72-95 lbs.

You can repeat the dose every 6-8 hours if necessary, but do not exceed four doses in a day. It's best to give the medication with food or milk if your child experiences any stomach upset. Always keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

When considering this product for older adults, it's important to consult with a doctor first, especially if you or your loved one has any existing health conditions. This includes high blood pressure, heart disease, liver cirrhosis (a serious liver condition), kidney disease, or a history of stroke. These conditions can affect how the product works and may require special attention or adjustments in dosage.

Keep in mind that the product does not provide specific directions or warnings for adult use, so professional guidance is essential to ensure safety and effectiveness. Always prioritize open communication with healthcare providers to address any concerns or questions you may have.

Renal Impairment

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

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (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 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 safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could indicate a safety issue.

By following these simple storage and handling guidelines, you can help maintain the quality and reliability 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 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 Ibuprofen?

Ibuprofen is an oral suspension pain reliever and fever reducer (NSAID) available in a bubble gum flavor, specifically for children aged 2 to 11 years.

How does Ibuprofen work?

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

What are the dosing instructions for Ibuprofen?

Dosing is based on weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

What should I do if my child experiences stomach upset?

If stomach upset occurs, give Ibuprofen with food or milk to help alleviate the discomfort.

Are there any contraindications for using Ibuprofen?

Do not use Ibuprofen if your child has had an allergic reaction to it or any other pain reliever/fever reducer, or if they are undergoing heart surgery.

What are the warnings associated with Ibuprofen?

Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I use Ibuprofen during pregnancy?

The safety of Ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester due to potential risks to the fetus.

Is it safe to use Ibuprofen while breastfeeding?

Nursing mothers should consult a doctor before using Ibuprofen, as there is a potential for excretion in breast milk.

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.

How should I store Ibuprofen?

Store Ibuprofen 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 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

Ibuprofen is an oral suspension formulated as a nonsteroidal anti-inflammatory drug (NSAID) with a concentration of 100 mg per 5 mL. This preparation is designed for the relief of pain and reduction of fever. The product is presented in a 4 fluid ounce (118 mL) container and features a bubble gum flavor. It is alcohol-free and gluten-free, making it suitable for a variety of patients.

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 dose based on the patient's weight or age.

Prior to administration, the product must be shaken well. The enclosed dosing cup should be used exclusively for measuring the dose; no other dosing devices are permitted.

The recommended dosing is as follows:

  • For patients weighing under 24 lbs or under 2 years of age, the dose should be determined by consulting a physician.

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

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

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

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

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

If necessary, doses may be repeated every 6 to 8 hours, but should not exceed four doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly to ensure hygiene.

To maintain child resistance, the original bottle cap must be replaced securely after each use. It is imperative that the product is not administered in excess of the directed dosage.

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 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), or those exceeding the recommended dosage or duration of use.

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

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. Healthcare professionals should be consulted promptly in such cases. 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.

Before administering ibuprofen, it is advisable to consult a healthcare provider 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, consultation with a doctor or pharmacist is recommended 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.

Parents and caregivers should discontinue use and contact 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 they experience any of the aforementioned signs of stomach bleeding or symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Furthermore, if symptoms do not improve within 24 hours, or if fever or pain worsens or persists beyond three days, medical advice should be sought.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, are dehydrated, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Special caution is warranted for patients under a doctor's care for serious conditions or those taking other medications.

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. It is advisable to assess the patient's allergy history before prescribing ibuprofen.

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

  • Coadministration with Other NSAIDs: The risk of stomach bleeding is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen. It is prudent to avoid the use of multiple NSAIDs concurrently to mitigate this risk.

Laboratory Test Interactions:

No specific laboratory test interactions have been identified in the available data. Regular monitoring of patient response and any potential side effects is advisable, although no direct laboratory test interactions are noted.

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 as follows: for those under 24 lbs (under 2 years), a physician should be consulted; for 24-35 lbs (2-3 years), the recommended dose is 5 mL; for 36-47 lbs (4-5 years), the dose is 7.5 mL; for 48-59 lbs (6-8 years), the dose is 10 mL; for 60-71 lbs (9-10 years), the dose is 12.5 mL; and for 72-95 lbs (11 years), the dose is 15 mL.

Doses may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. It is advised to administer the medication with food or milk if stomach upset occurs. Care should be taken to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, as it does not contain specific directions or complete warnings for adult use. It is imperative for healthcare providers to assess the individual health status of geriatric patients prior to administration.

Particular attention should be given to patients aged 65 and older who have underlying health conditions. Healthcare providers are advised to inquire about the presence of high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke before recommending this product. Monitoring for potential adverse effects and interactions is essential in this population to ensure safety and efficacy.

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.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options. It is essential for healthcare professionals to consider these factors when prescribing medications to pregnant patients.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this medication to nursing mothers due to the potential risk to the infant.

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 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, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, 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. Careful consideration should be given to the overall health status of these patients, particularly if they also present with comorbidities such as high blood pressure, heart disease, or kidney disease.

Regular follow-up and reassessment of liver function are crucial to ensure the safe and effective use of the medication in this population.

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. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate appropriate management procedures based on the clinical presentation and the specific agent involved in the overdose.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to implement standard protocols for overdose management, including the administration of activated charcoal if indicated and the provision of symptomatic treatment as required.

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 use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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 patient experiences stomach upset.

Providers should encourage patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to ask about any previous serious side effects from pain relievers or fever reducers, and to confirm whether the child has been adequately hydrated, especially if there has been significant fluid loss due to vomiting or diarrhea.

Patients should be instructed to consult a healthcare professional if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. It is also crucial to inquire if the child is taking a diuretic or is under a doctor’s care for any serious condition, as well as to check for any other medications being taken concurrently.

Providers should inform patients to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, if the child shows symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, immediate medical consultation is necessary.

Patients should also be advised to stop use and consult a doctor if there is no relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise.

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; it 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 remains effective and safe for patient 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 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

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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.