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Basic 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 2021
Label revision date
November 30, 2021
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 2021
Label revision date
November 30, 2021
Manufacturer
Amazon. com Services LLC
Registration number
ANDA074937
NDC root
72288-166
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 is an oral suspension medication designed for children aged 2 to 11 years. It contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever and provides relief that can last up to 8 hours.

This medication is alcohol-free and comes in a pleasant bubble gum flavor, making it easier for children to take. It is comparable to the active ingredient found in Children’s Motrin®.

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 note that it does not come with complete 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 should find the right dose by referring to the dosing chart provided, which is based on weight. If you can't use weight, you can use age as a guide.

For children weighing under 24 pounds (under 2 years), it's best to consult a doctor before giving any dose. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL (milliliters). As the weight increases, so does the dose: 7.5 mL for 36-47 pounds (ages 4-5), 10 mL for 48-59 pounds (ages 6-8), 12.5 mL for 60-71 pounds (ages 9-10), and 15 mL for children weighing 72-95 pounds (11 years). You can repeat the dose every 6-8 hours if necessary, but do not use it more than four times a day. Always use the enclosed dosing cup for accuracy, and remember to wash it after each use. Finally, make sure to replace the original bottle cap to keep it child-resistant.

What to Avoid

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, chest pain, difficulty breathing, or weakness on one side of the body, 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 persist or worsen. Always discuss any pre-existing health conditions or medications with a healthcare provider before use.

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 and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding issues, 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 consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get 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.

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 nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may pose risks to your developing baby, including potential cardiovascular issues.

If you are pregnant or planning to become pregnant, it’s important to consult your healthcare provider before using ibuprofen. 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 or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the medication can pass into your breast milk, and the effects on nursing infants have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution when considering this medication while nursing. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your baby.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight and age. For example, if your child weighs between 24-35 pounds and is 2-3 years old, the recommended dose is 5 mL. Always consult your doctor if your child has a history of stomach issues, is dehydrated from vomiting or diarrhea, or has conditions like high blood pressure, heart disease, or asthma.

Additionally, you should not use this medication for more than 2 days without a doctor's guidance. If your child shows any signs of stomach bleeding, such as feeling faint or having bloody stools, stop using the medication immediately and seek medical help. If your child does not feel better within 24 hours or if their fever or pain worsens or lasts more than 3 days, please consult a doctor.

Geriatric Use

When considering this product, it's important to note that it does not provide specific directions or complete warnings for adult use, including older adults. This means that if you or a loved one is an older adult, you should be particularly cautious and consult with a healthcare professional before using it.

Always ensure that any medication or treatment is appropriate for your individual health needs, especially if there are existing health conditions or concerns. Your healthcare provider can help guide you on safe usage and any necessary adjustments based on age-related factors.

Renal Impairment

If you have kidney problems, it's important to be aware of how they can affect your health. Conditions like high blood pressure, heart disease, liver cirrhosis (scarring of the liver), and a history of stroke can complicate your kidney issues.

Make sure to discuss your complete medical history with your healthcare provider, as they may need to adjust your treatment plan or monitor your kidney function more closely. This could involve regular tests to check how well your kidneys are working and ensuring that any medications you take are safe for your condition. Always follow your doctor's advice to manage your health effectively.

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, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of serious stomach bleeding increases. This risk is also heightened if other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen are being used.

Using ibuprofen for longer than recommended can raise the chances of heart-related issues, such as heart attack or stroke. Always consult with a healthcare provider before starting ibuprofen or if your child is taking any other medications. This ensures safe use and helps prevent any serious complications.

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 needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

To avoid stomach upset, consider taking the medication with food or milk. Always use the enclosed dosing cup for measuring your dose, and make sure to shake the bottle well before use. Do not use the medication if the printed neckband is broken or missing, and store it at room temperature between 20-25°C (68-77°F). Avoid freezing the medication.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension that contains 100 mg of ibuprofen per 5 mL, used to relieve minor aches and pains and reduce fever in children.

What age group can use Children's Ibuprofen?

Children's Ibuprofen is intended for children aged 2 to 11 years.

How should I dose Children's Ibuprofen?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight. Do not exceed the recommended dose.

What are the side effects of Children's Ibuprofen?

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

Can I give Children's Ibuprofen to my child if they have allergies?

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

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 during the third trimester.

What should I do if my child experiences signs of stomach bleeding?

If your child feels faint, vomits blood, or has bloody or black stools, stop use and consult a doctor immediately.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact.

What should I do in case of an overdose?

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

Can I give Children's Ibuprofen with food?

Yes, you can give Children's Ibuprofen with food or milk if your child experiences stomach upset.

Packaging Info

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

Packaging configurations for Basic Care Childrens Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Basic 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 to provide pain relief and reduce fever. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is designed for pediatric use and is alcohol-free, featuring a bubble gum flavor to enhance palatability. The suspension is packaged in an 8 fluid ounce (240 mL) bottle and is effective for up to 8 hours.

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

For children weighing under 24 lbs (under 2 years), it is advised to consult a doctor before administration. For children weighing between 24-35 lbs (2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (4-5 years), the dose increases to 7.5 mL. Children weighing 48-59 lbs (6-8 years) should receive 10 mL, while those weighing 60-71 lbs (9-10 years) should be given 12.5 mL. For children weighing 72-95 lbs (11 years), the appropriate dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but should not exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

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

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

NSAIDs, with the exception of 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 an extended period.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Patients should be advised to consult a physician promptly and to avoid using ibuprofen for more than two days or administering it to children under three years of age unless directed by a healthcare provider.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain; symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

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.

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 potential severe stomach bleeding, especially 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 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 or for longer than directed.

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 the 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.

Additional precautions should be taken for patients with a history of stomach problems, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients consult a healthcare provider before use if they are under medical care for any serious condition or are taking other medications.

Drug Interactions

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

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

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. This risk is also heightened when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Monitoring for gastrointestinal symptoms is advised in patients receiving these combinations.

Cardiovascular Risks There is an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke, associated with ibuprofen, particularly when used in higher doses or for extended periods. Healthcare providers should evaluate the necessity of ibuprofen therapy and consider alternative treatments when appropriate.

Consultation Recommendations It is recommended that healthcare providers consult with a physician if the patient is taking any other medications. This ensures a comprehensive review of potential interactions and the implementation of necessary dosage adjustments or monitoring strategies.

Packaging & NDC

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

Packaging configurations for Basic 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:

  • For those under 24 lbs (under 2 years), consult a doctor.

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, such as heartburn, or 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 high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Children taking diuretics or under a doctor's care for any serious condition should also be evaluated by a healthcare professional before use. The medication should not be used for more than 2 days in pediatric patients or administered to those under 3 years of age without medical guidance.

If any signs of stomach bleeding occur, such as feeling faint, vomiting blood, or having bloody or black stools, the medication should be discontinued immediately, and a doctor should be consulted. 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 healthcare professional should be contacted.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is essential to evaluate the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

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

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied. Therefore, caution is advised when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function should be assessed for potential changes in drug clearance. It is essential to evaluate 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 further complicate the management of therapy in this population. Regular monitoring of renal function is recommended to ensure safe and effective use of the medication in patients with compromised renal status.

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 treatment plan and monitoring requirements for those with hepatic impairment.

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

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should ensure that they are familiar with the appropriate protocols for the substance in question to facilitate effective treatment.

Nonclinical Toxicology

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

Postmarketing Experience

Allergic reactions have been reported in the postmarketing experience, including manifestations such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been documented in patients using nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen. Furthermore, occurrences of heart attack and stroke have also been reported among patients taking NSAIDs, including ibuprofen. These events were reported voluntarily or identified through surveillance programs.

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 crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

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

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. It is essential to use only the enclosed dosing cup for administration and to shake the bottle well before use. Patients should be instructed 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. Additionally, the medication should not be used if the printed neckband is broken or missing, and it should be stored at a temperature of 20-25°C (68-77°F), avoiding freezing.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Basic 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 Basic 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.