Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Ibuprofen

Last content change checked dailysee data sync status

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 2024
Label revision date
March 27, 2024
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 2024
Label revision date
March 27, 2024
Manufacturer
Family Dollar Services, Inc.
Registration number
ANDA210755
NDC root
55319-637
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

FAMILY Wellness is a concentrated oral suspension that contains ibuprofen, a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed for infants aged 6 months to 23 months and is used to reduce fever and relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headaches, and toothaches.

This product is dye-free and comes in a pleasant berry flavor, making it easier for young children to take. Each 1.25 mL dose contains 50 mg of ibuprofen, providing effective relief for your little one when they need it most.

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 adults. Always make sure to follow the recommended dosage and never exceed the amount 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 dosing; if not, you can use their age. For example, if your child is between 12 to 17 pounds (6 to 11 months old), the correct dose is 1.25 mL, and for those weighing 18 to 23 pounds (12 to 23 months), it’s 1.875 mL. Always measure the dose using the dosing device provided, as other devices may not give accurate measurements. When administering 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 give more than four doses in a single day. If your child is under 6 months old, consult a doctor before use.

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, especially in those who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. Additionally, this medication can lead to severe stomach bleeding, particularly in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, especially if used in higher doses or for longer than recommended.

If your child experiences symptoms such as faintness, vomiting blood, black or bloody stools, or persistent stomach pain, you should seek medical attention immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. It's important to consult a doctor if your child does not find relief within 24 hours, if their fever or pain worsens, or if new symptoms arise. Always talk to a healthcare professional before using ibuprofen if your child has a history of stomach issues, is dehydrated, or has other serious health conditions.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using 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 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 or your child have a severe sore throat with high fever, headache, nausea, or vomiting, consult a doctor right away and do not use ibuprofen for more than two days without medical advice.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help immediately. You should also stop taking ibuprofen and call your doctor if you notice any signs of stomach bleeding (like faintness, vomiting blood, or black stools), symptoms of heart problems or stroke (such as chest pain or trouble breathing), or if there is no relief within 24 hours. Additionally, seek medical advice if fever or pain worsens or lasts more than three days, or if new symptoms appear.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, you might notice symptoms such as nausea, vomiting, stomach pain, drowsiness, or headache. In more severe cases, an overdose can result in kidney failure, liver damage, or gastrointestinal bleeding.

If you suspect an overdose, it’s crucial to seek immediate medical attention. Don’t wait for symptoms to worsen; getting help quickly can make a significant difference in treatment outcomes. Always prioritize safety and consult a healthcare professional if you have any concerns about medication use.

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, using ibuprofen during pregnancy, especially in the third trimester, is not recommended because it can pose risks to your baby. These risks may include issues like kidney problems in the fetus, low amniotic fluid (oligohydramnios), and potential heart-related effects.

Before taking ibuprofen, you should always consult your healthcare provider, particularly if you are in the later stages of your pregnancy. They can help you understand the safest options for managing any discomfort you may experience.

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 any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years old unless a doctor specifically advises you to do so. For younger children, the dosage varies: if your child is under 6 months, consult a doctor first. For those between 6 to 11 months and weighing 12-17 lbs, the recommended dose is 1.25 mL, while children weighing 18-23 lbs (12-23 months) should receive 1.875 mL.

Always use the dosing device included with the medication and do not exceed 4 doses in a 24-hour period. If your child's symptoms do not improve within 24 hours, or if they show any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and consult a doctor. Additionally, it's wise to talk to a doctor if your child has a history of stomach issues, is taking other medications, or is not drinking enough fluids.

Geriatric Use

While the drug insert does not provide specific information about its use in older adults, it is important to approach medication with caution as you age. Since the insert mainly discusses pediatric use, there are no recommended dosage adjustments or safety guidelines specifically for elderly patients.

If you or a loved one is an older adult considering this medication, it’s wise to consult with a healthcare provider. They can help assess any individual health needs and ensure that the medication is safe and appropriate for you. Always prioritize open communication with your healthcare team about any concerns or questions regarding medications.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to be aware of potential interactions when your child is taking medications. For instance, if your child is using ibuprofen, it can increase the risk of severe stomach bleeding, particularly if they are also taking blood thinners (medications that prevent blood clots) or steroids. Additionally, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can further elevate this risk.

Always discuss any medications your child is taking with their healthcare provider to ensure safety and avoid harmful interactions. This conversation is crucial for managing your child's health effectively.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its quality. It's important to check the packaging before use; do not use the product if the carton is opened or if the printed neckband that says "SEALED FOR YOUR PROTECTION" is broken or missing. Additionally, always use the enclosed dosing device as instructed to ensure proper dosing and safety.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. If you experience stomach upset, it's advisable to take the medication with food or milk.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

FAQ

What is FAMILY Wellness?

FAMILY Wellness is a concentrated drops oral suspension that compares to the active ingredient in Infants' Motrin, containing ibuprofen, and is suitable for infants aged 6 to 23 months.

What are the uses of FAMILY Wellness?

It reduces fever and relieves minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

How should I administer FAMILY Wellness?

Use the enclosed syringe to measure the correct dose, dispense the liquid slowly into the child's mouth toward the inner cheek, and do not exceed 4 doses in a 24-hour period.

What is the dosing chart for FAMILY Wellness?

For infants under 6 months, consult a doctor. For 12-17 lbs (6-11 months), the dose is 1.25 mL, and for 18-23 lbs (12-23 months), the dose is 1.875 mL.

Are there any contraindications for using FAMILY Wellness?

Do not use if the child has had an allergic reaction to ibuprofen or any other pain reliever/fever reducer, or if used right before or after heart surgery.

What should I do if my child experiences side effects?

Stop use and consult a doctor if your child shows signs of stomach bleeding, heart problems, or if symptoms do not improve within 24 hours.

Is FAMILY Wellness safe during pregnancy?

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

Can I use FAMILY Wellness if my child is taking other medications?

Consult a doctor before use if your child is taking other medications or has a history of stomach problems.

What are the storage instructions for FAMILY Wellness?

Store FAMILY Wellness between 20-25°C (68-77°F) and do not use if the carton is opened or if the seal is broken.

Packaging Info

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

Packaging configurations for Infants Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

FAMILY Wellness™ infants' ibuprofen concentrated drops oral suspension is formulated to provide pain relief and reduce fever in infants aged 6 months to 23 months. Each 1.25 mL dose contains 50 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is presented in a 1 FL OZ (30 mL) bottle and is dye-free, featuring a berry flavor for palatability. Administration is facilitated through the use of 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 healthcare professionals should ensure that the appropriate dosage is administered based on the child's weight or age, as outlined in the dosing chart below. It is imperative to adhere to the maximum dosing recommendations and to avoid exceeding the prescribed limits.

Prior to administration, the product must be shaken well. The dosing device provided should be used to measure the liquid accurately; no other dosing devices should be utilized to ensure proper dosing. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek to facilitate swallowing.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides specific recommendations based on weight:

  • For infants under 6 months of age, consultation with a physician is required before administration.

  • For infants weighing 12 to 17 lbs (6 to 11 months), the recommended dose is 1.25 mL.

  • For infants weighing 18 to 23 lbs (12 to 23 months), the recommended dose is 1.875 mL.

Healthcare professionals should ensure that caregivers are informed not to exceed the recommended dosage and to seek medical advice if there are any uncertainties regarding the appropriate use of this product.

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 immediately before or after heart surgery due to potential complications associated with surgical recovery.

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.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, and individuals taking other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the likelihood of gastrointestinal complications.

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

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. Ibuprofen should not be administered for more than two days, nor should it be given to children under three years of age unless specifically directed by a healthcare provider.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Healthcare providers should instruct caregivers to discontinue ibuprofen and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, further medical assessment is necessary. Any new or unusual symptoms should also prompt a consultation with a healthcare professional.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Patients should be monitored for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should be vigilant for symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include a sore throat, especially if it is severe or persistent, or accompanied by high fever, headache, nausea, and vomiting. In such cases, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and seek medical advice if they do not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Additional caution is warranted for patients with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also recommended that patients under a doctor's care for any serious condition or those taking other medications consult a healthcare professional prior to use.

Drug Interactions

Ibuprofen is associated with an increased risk of severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or steroid medications. Clinicians should exercise caution when prescribing ibuprofen to patients who are concurrently taking these classes of drugs, as the potential for adverse effects is heightened.

Additionally, the risk of gastrointestinal bleeding is further amplified if the patient is using other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen. It is advisable to monitor patients closely for signs of gastrointestinal distress and consider dosage adjustments or alternative therapies when multiple NSAIDs are involved.

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

Packaging & NDC

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

Packaging configurations for Infants Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For dosing, the following guidelines apply: infants under 6 months should consult a doctor before use; for those weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL; and for children weighing 18-23 lbs (12-23 months), the dose is 1.875 mL.

It is essential to consult a doctor if the child has a history of stomach problems, is taking other medications, or has not been adequately hydrated. The maximum dosage should not exceed 4 doses within a 24-hour period. If symptoms do not improve within 24 hours, a healthcare professional should be consulted. Parents or caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. The medication should only be administered using the enclosed dosing device.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the absence of data may necessitate careful monitoring and individualized assessment of treatment risks and benefits.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. The use of ibuprofen during pregnancy may be associated with risks such as fetal renal impairment, oligohydramnios, and potential cardiovascular effects.

Pregnant women should consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy. It is essential for healthcare professionals to weigh the potential risks against the benefits when considering the use of ibuprofen in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available about the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of ibuprofen can result in significant adverse effects that require prompt medical intervention.

Symptoms of Overdose Healthcare professionals should be aware that symptoms of ibuprofen overdose may manifest as nausea, vomiting, stomach pain, drowsiness, and headache. These symptoms can vary in severity depending on the amount ingested and the individual’s health status.

Severe Complications In more severe cases, an overdose may lead to critical complications such as kidney failure, liver damage, or gastrointestinal bleeding. These conditions necessitate immediate medical evaluation and intervention to mitigate potential long-term consequences.

Recommended Actions If an ibuprofen overdose is suspected, it is imperative to seek immediate medical attention. Timely intervention can significantly improve outcomes and reduce the risk of serious health complications. Healthcare providers should be prepared to conduct a thorough assessment and initiate appropriate management strategies based on the severity of the overdose.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients with a history of stomach ulcers or bleeding problems, or those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is also an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, especially associated with prolonged use or doses exceeding the recommended guidelines. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been documented as serious conditions that necessitate prompt medical consultation.

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 that the medication be taken with food or milk if the patient 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 also be counseled to stop use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if the stomach bleeding warning is applicable to the child, if there is a history of stomach issues such as heartburn, or if the child has previously experienced serious side effects from pain relievers or fever reducers. It is also important to advise patients to seek medical advice if the child has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Furthermore, patients should be reminded to consult a doctor before use if the child has asthma, is taking a diuretic, or is under medical care for any serious condition. Lastly, it is advisable for patients to check with a doctor or pharmacist before use if the child is currently taking any other medications.

Storage and Handling

The product is supplied in a carton that must remain sealed until use. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Healthcare professionals should ensure that the carton is not opened prior to use. Additionally, the product should not be utilized if the printed neckband is imprinted with "SEALED FOR YOUR PROTECTION" and the phrase "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing, as this indicates potential tampering or compromised integrity.

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. Patients are advised to take the medication with food or milk if they experience stomach upset. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 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.