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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/ Drops
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
May 4, 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/ Drops
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
May 4, 2021
Manufacturer
Amazon. com Services LLC
Registration number
ANDA075217
NDC root
72288-255
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 an oral suspension designed specifically for infants aged 6 to 23 months. It contains 50 mg of ibuprofen per 1.25 mL and is used to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headaches, and toothaches. Additionally, it acts as a fever reducer, helping to lower elevated body temperatures.

This medication is a non-steroidal anti-inflammatory drug (NSAID), which means it works by reducing inflammation and pain in the body. Infants’ Ibuprofen is available in a berry flavor and is dye-free, making it a gentle option for your little one. It can provide relief for up to 8 hours, ensuring your child feels more comfortable during times of discomfort.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions like 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 adult use. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use. You can find the right dose by referring to the dosing chart, which suggests using your child's weight for the most accurate measurement. If weight isn't available, you can use their age instead.

When measuring the dose, use the dosing device that comes with the product, as other devices may not provide accurate measurements. For administration, slowly dispense the liquid 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 infants under 6 months, it's best to consult a doctor before giving any medication.

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 your child's safety by following these guidelines closely. If you have any concerns or questions about using this 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 faintness, vomiting blood, or black stools, or shows signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. It's important to consult a doctor if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, asthma (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 symptoms of heart problems like chest pain or trouble breathing, 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

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no contraindications (conditions that would prevent its use) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the text does not highlight any special precautions you should take if you are pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of ibuprofen while nursing. The information available does not indicate whether ibuprofen is excreted in breast milk or if there are any associated risks for your infant.

However, it's always a good idea to consult with your healthcare provider before taking any medication while breastfeeding, just to ensure the best care for you and your baby.

Pediatric Use

It's important to be cautious when giving medication to children. For children under 3 years old, you should only use this medication if directed by a doctor. If your child is between 6 months and 23 months, the dosage will depend on their weight, so consult a doctor for children under 6 months. For those aged 6-11 months weighing 12-17 lbs, the dose is 1.25 mL, and for those weighing 18-23 lbs (12-23 months), the dose is 1.875 mL.

Before giving this medication, check with your doctor if your child has had any allergic reactions to pain relievers, has a history of stomach issues, or has lost fluids due to vomiting or diarrhea. It's also important to consult a doctor if your child has high blood pressure, heart disease, liver or kidney problems, asthma, or is taking other medications. If your child experiences any unusual symptoms, such as signs of stomach bleeding or heart problems, stop using the medication and seek medical advice. Always follow the dosing instructions carefully, do not exceed four doses in a day, and shake the liquid well before administering it.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is important to note that the product is primarily indicated for infants. This means that there are no detailed directions or warnings for adult use, including for older adults.

If you are caring for an older adult, it’s essential to consult a healthcare professional before using this product to ensure it is safe and appropriate for their needs. Always prioritize their health and well-being by seeking guidance tailored to their specific situation.

Renal Impairment

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

Hepatic Impairment

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

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

Drug Interactions

It's important to be aware that ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Additionally, if your child is taking blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if your child is using other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Before giving ibuprofen to your child, make sure to consult with a healthcare provider or pharmacist, especially if they are on any other medications. This conversation is crucial to ensure their safety and to avoid any potentially harmful interactions.

Storage and Handling

To ensure the best performance and safety 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 compromise its safety and effectiveness.

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. It's important to keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What is Infants’ Ibuprofen?

Infants’ Ibuprofen is an oral suspension that contains 50 mg of ibuprofen per 1.25 mL. It is used as a pain reliever and fever reducer.

What age group is Infants’ Ibuprofen intended for?

Infants’ Ibuprofen is intended for children aged 6 to 23 months.

How does Infants’ Ibuprofen work?

It works as a nonsteroidal anti-inflammatory drug (NSAID) to reduce fever and relieve minor aches and pains from conditions like the common cold, flu, and toothaches.

What is the recommended dosage for Infants’ Ibuprofen?

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

What should I do if my child experiences stomach bleeding?

If your child shows signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop use and seek medical help immediately.

Are there any allergies associated with Infants’ Ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, especially in those allergic to aspirin. Symptoms can include hives, swelling, and difficulty breathing.

Can I give Infants’ Ibuprofen to my child if they have had an allergic reaction to pain relievers?

No, do not use Infants’ Ibuprofen if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

How often can I give Infants’ Ibuprofen?

You can repeat the dose every 6-8 hours, but do not exceed 4 doses in a 24-hour period.

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 of treatment, or if symptoms worsen, consult a doctor.

Is there any specific storage requirement for Infants’ Ibuprofen?

Store Infants’ Ibuprofen at 20-25°C (68-77°F) and do not freeze it. 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, delivering 50 mg of ibuprofen per 1.25 mL. This non-steroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer, providing relief that lasts up to 8 hours. The formulation is non-staining and free from dyes and high fructose corn syrup, with a berry flavor for palatability. The product is packaged in a 1 FL OZ (30 mL) bottle and is intended for use with the enclosed syringe.

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 does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage administered does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosing chart provided below. When possible, weight should be used to determine the dose; if weight is not available, age may be used as an alternative.

The dosing device provided with the product must be used for measurement; other devices should not be utilized. 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.

Dosing Chart:

  • For children under 6 months of age or weighing less than 12 lbs, consultation with a physician is advised.

  • For children weighing 12-17 lbs (approximately 6-11 months of age), the recommended dose is 1.25 mL.

  • For children weighing 18-23 lbs (approximately 12-23 months of age), the recommended dose is 1.875 mL.

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 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, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of gastrointestinal complications.

NSAIDs, excluding aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

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. Consultation with a physician is advised if symptoms persist beyond two days or if the medication is to be administered to children under three years of age without prior medical guidance.

Patients should be instructed to discontinue use and consult a healthcare provider 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 should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen carries a warning for potential severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroids, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of use.

Additionally, ibuprofen is associated with an increased 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 directed dosage or for prolonged periods.

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 not to use ibuprofen for more than two days in cases of sore throat or to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. 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, they should seek medical advice. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use. Additionally, it is recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional before using ibuprofen.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Therefore, it is imperative to monitor these patients closely and consider alternative pain management strategies if necessary.

Additionally, the risk of stomach bleeding is elevated when ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Healthcare providers should advise caregivers to consult with a physician or pharmacist prior to administering ibuprofen if the child is currently taking any other medications. This precaution helps to mitigate potential adverse effects and ensures safe therapeutic practices.

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 dosing, a weight and age chart is provided: infants under 6 months should consult a doctor; those weighing 12-17 lbs (6-11 months) may receive 1.25 mL, and those weighing 18-23 lbs (12-23 months) may receive 1.875 mL.

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, or if there are any stomach issues such as heartburn. Additionally, a consultation is warranted if the child has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea.

Caution is advised for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Those with asthma or who are taking diuretics should also seek medical advice. It is important to consult a doctor if the child is under care for any serious condition or is taking other medications.

Parents or guardians should discontinue use and consult a doctor if the child exhibits signs of stomach bleeding (e.g., feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain) or symptoms indicative of heart problems or stroke (e.g., chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling). If the child does not experience relief within the first 24 hours of treatment, or if the medication is needed more than four times a day, medical advice should be sought.

It is recommended to shake the liquid well before use and dispense it slowly into the child’s mouth, directing it toward the inner cheek.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the insert does not provide guidance on geriatric use. It is important to note that the product is primarily indicated for infants, and therefore, it lacks directions or complete warnings pertinent to adult populations, including geriatric patients.

Healthcare providers should exercise caution when considering the use of this product in elderly patients, given the absence of established safety and efficacy data in this demographic. Monitoring for potential adverse effects and evaluating the necessity of dosage adjustments may be prudent, although specific recommendations are not available.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions outlined regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in lactating mothers. The insert does not provide information on the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment period.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. It is crucial to consider the overall health status of these patients, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these may further complicate their treatment regimen.

Healthcare providers should exercise caution and tailor the treatment approach based on the individual patient's liver function and overall clinical picture.

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 support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

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 a doctor before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Patients should also be advised to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke. If the child has asthma or is taking a diuretic, a discussion with a healthcare provider is essential prior to use. Furthermore, patients should be encouraged to speak with a doctor or pharmacist if the child is 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. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately 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

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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.