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Basic Care Infants Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 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
October 8, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 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
October 8, 2021
Manufacturer
Amazon. com Services LLC
Registration number
ANDA075217
NDC root
72288-057
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

Infants’ Ibuprofen is a liquid medication designed specifically for infants aged 6 months to 23 months. It is an oral suspension that contains 50 mg of ibuprofen per 1.25 mL and is flavored with berry to make it more palatable for young children. This medication is primarily used to reduce fever and relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

As a nonsteroidal anti-inflammatory drug (NSAID), Infants’ Ibuprofen works by decreasing inflammation and pain in the body, providing comfort to your little one when they are feeling unwell. It is important to use the enclosed syringe for accurate dosing and to follow any specific instructions provided.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use.

To find the right dose for your child, refer to the dosing chart. If possible, use your child's weight for the most accurate measurement; otherwise, you can use their age. For measuring, use the dosing device that comes with the product—do not use any other device. When giving the liquid, dispense it slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day.

For children under 6 months, it's best to consult a doctor before administering this medication. For children weighing between 12 to 17 pounds (6 to 11 months), the dose is 1.25 mL, and for those weighing 18 to 23 pounds (12 to 23 months), the dose is 1.875 mL.

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.

Always prioritize safety by following these guidelines closely. If you have any concerns or questions about your child's health or medication, consult with a healthcare professional for personalized advice.

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, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always discuss any pre-existing health conditions or medications with a healthcare provider before using ibuprofen.

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 the medication 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 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 consulting a doctor, 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, seek medical advice. In case of an overdose, get emergency 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

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby. These risks can include potential heart problems and kidney issues for the fetus.

Before taking ibuprofen, you should always consult your healthcare provider. They can provide guidance on whether you need to adjust your dosage or consider alternative pain relief options that are safer during pregnancy. Your health and the health of your baby are the top priority, so make sure to discuss any medications with your doctor.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's wise to be cautious.

If you do decide to take this medication, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help guide you on the best course of action for both you and your child.

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 6 to 23 months, the dosage depends on their weight: if your child weighs between 12-17 pounds, the dose is 1.25 mL, and for those weighing 18-23 pounds, the dose is 1.875 mL. Always consult a doctor before using this medication for children under 6 months.

Make sure not to use this medication for more than 2 days without a doctor's guidance. If your child has been dehydrated from vomiting or diarrhea, or if they show any signs of stomach bleeding—like feeling faint, vomiting blood, or having black or bloody stools—stop using the medication and contact a doctor immediately. Additionally, if your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, seek medical advice.

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

Hepatic Impairment

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

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these conditions can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to talk to your healthcare provider about any medications your child is taking, especially if they are prescribed ibuprofen. This is because ibuprofen can increase the risk of stomach bleeding, particularly if your child is also taking blood thinners (medications that prevent blood clots) or steroids. Additionally, using ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, may raise the risk of serious heart issues, including heart attack and stroke.

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 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 indicate that the product is compromised.

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

Additional Information

You should take this medication orally, dispensing the liquid slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day.

It's important to keep this medication out of reach of children. If an overdose occurs, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Infants’ Ibuprofen used for?

Infants’ Ibuprofen is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What is the recommended dosage for Infants’ Ibuprofen?

For infants aged 6-11 months weighing 12-17 lbs, the dose is 1.25 mL. For infants aged 12-23 months weighing 18-23 lbs, the dose is 1.875 mL. Always consult the dosing chart and use the provided syringe.

Are there any warnings associated with Infants’ Ibuprofen?

Yes, it 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 Infants’ Ibuprofen be used 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.

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor immediately.

How should Infants’ Ibuprofen be administered?

Administer the liquid slowly into the child’s mouth toward the inner cheek. Shake well before use and do not exceed 4 doses in a day.

What should I do if my child does not get relief from Infants’ Ibuprofen?

If your child does not experience relief within the first 24 hours, or if fever or pain worsens or lasts more than 3 days, consult a doctor.

Is it safe to use Infants’ Ibuprofen while breastfeeding?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk and effects on the nursing infant are not well studied.

What storage conditions are recommended for Infants’ Ibuprofen?

Store Infants’ 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 Basic Care Infants Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Basic Care Infants Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Infants’ Ibuprofen is an oral suspension formulated as a concentrated drop, containing 50 mg of the active ingredient per 1.25 mL. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer, providing relief that lasts up to 8 hours. The product is presented in a 1 FL OZ (30 mL) bottle and is flavored with berry to enhance palatability. Administration is facilitated through the use of the enclosed syringe, ensuring accurate dosing.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should ensure that dosing is based on the child's weight whenever possible. If weight is not available, age may be used as a guide.

Prior to administration, the product must be shaken well. The appropriate dose should be measured using the dosing device provided; no other measuring device should be utilized to ensure accuracy.

For children under 6 months of age, it is advised to consult a physician before administration. For children weighing between 12 to 17 pounds (approximately 6 to 11 months), the recommended dose is 1.25 mL. For those weighing between 18 to 23 pounds (approximately 12 to 23 months), the recommended dose is 1.875 mL.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek to facilitate swallowing. Dosing may be repeated every 6 to 8 hours as needed, but should not exceed 4 doses in a 24-hour period. It is imperative that the total daily dosage does not exceed the specified limits.

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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of such an event 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 treatment may further elevate this risk.

NSAIDs, with the exception of aspirin, are known to increase the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

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. It is advised to consult a physician promptly in such cases. Furthermore, ibuprofen should not be administered for more than two days, nor to children under three years of age, unless directed by a healthcare provider.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing 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 cases of overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

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 warning for severe stomach bleeding. The risk of this serious adverse reaction 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. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, and the risk escalates with higher doses or extended duration of use.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation.

Patients are advised to discontinue use and seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also necessitate immediate medical evaluation.

Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

It is recommended that patients consult a doctor before use 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 a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use. Careful consideration is advised for patients under a physician's care for serious conditions or those taking other medications.

Drug Interactions

Ibuprofen may increase the risk of gastrointestinal bleeding, particularly in pediatric patients concurrently using anticoagulants or corticosteroids. Clinicians should exercise caution and consider monitoring for signs of bleeding in these patients.

Additionally, the concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen, may elevate the risk of serious cardiovascular events, including heart attack, heart failure, and stroke. It is advisable to assess the necessity of ibuprofen in patients already receiving other NSAIDs and to monitor for any cardiovascular symptoms during treatment.

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

Packaging & NDC

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

Packaging configurations for Basic Care Infants Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 6 to 23 months, specific dosing is recommended based on weight: for those weighing 12-17 lbs (6-11 months), the dose is 1.25 mL; for those weighing 18-23 lbs (12-23 months), the dose is 1.875 mL.

Parents or caregivers should consult a doctor before use in children under 6 months of age. The medication should not be used for more than 2 days in pediatric patients without medical advice.

In cases where a child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea, medical consultation is advised. If any signs of stomach bleeding occur—such as faintness, vomiting blood, bloody or black stools, or persistent stomach pain—the medication should be discontinued, and a doctor should be contacted immediately.

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 consulted.

Geriatric Use

Elderly patients may not receive comprehensive directions or warnings regarding the use of this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary based on individual patient needs and responses. Given the lack of specific guidance for adult use, careful evaluation and clinical judgment are paramount when treating geriatric patients with this product.

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 be associated with adverse fetal outcomes, such as cardiovascular effects and renal impairment.

Pregnant patients are advised to consult their healthcare provider before using ibuprofen. Dosage modifications may be necessary, and healthcare providers can offer guidance tailored to individual circumstances. It is essential for women of childbearing potential to consider these factors when evaluating the use of ibuprofen during pregnancy.

Lactation

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

Overall, a thorough assessment and ongoing monitoring are critical for optimizing treatment in patients 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 potential overdose situations. 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 should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve activated charcoal administration, intravenous fluids, or other interventions based on the clinical presentation.

It is vital for healthcare professionals to remain vigilant and prepared to address any complications that may arise from an overdose, ensuring the best possible outcomes for affected individuals.

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 elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with ibuprofen use, reported voluntarily or through surveillance programs. These include hives, facial swelling, asthma characterized by wheezing, shock, skin reddening, rash, and blisters.

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 stomach pain that does not improve. Additionally, healthcare providers should inform patients to stop use and seek medical advice 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 counseled to monitor the child’s response to treatment. If the child does not experience relief within the first 24 hours, or if fever or pain worsens or persists beyond three days, they should contact a healthcare professional. Redness or swelling in the painful area or the appearance of any new symptoms should also prompt a consultation 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. Patients should also be advised to seek medical advice 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 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 clinicians advised to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. If necessary, the dose may be repeated every 6 to 8 hours, but it should not be used more than four times a day.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Basic Care Infants 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 Infants 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.