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Health Sense Infants Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
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 2009
Label revision date
May 22, 2009
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
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 2009
Label revision date
May 22, 2009
Manufacturer
Dolgencorp Inc
Registration number
ANDA075217
NDC root
55910-057
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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If you are a consumer or patient please visit this version.

Drug Overview

Infants' Ibuprofen Oral Suspension is a concentrated pain reliever and fever reducer specifically designed for infants aged 6 to 23 months. Each 1.25 mL dose contains 50 mg of ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). This medication helps reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

The effects of Infants' Ibuprofen can last for up to 8 hours, providing comfort for your little one when they need it most. It comes in a pleasant berry flavor and is alcohol-free, making it suitable for young children.

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 experiencing mild pain, this medication can provide some relief to help you feel better.

Dosage and Administration

Before using this medication, it's important to know that it doesn't come with complete instructions for adults. Always follow the recommended dosage and never exceed the amount directed. You should not use this medication for more than 10 days unless your doctor advises otherwise.

To prepare the medication, make sure to shake the bottle well before use. You can find the correct dose based on your child's weight or age. Use the dosing device that comes with the product to measure the liquid accurately—do not use any other device. When giving the medication, 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 specific dosing: if your child is under 6 months old, consult a doctor first. 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. Always ensure you are following these guidelines closely for your child's safety.

What to Avoid

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of stomach bleeding, especially if you or your child have a history of stomach ulcers, are taking blood thinners or steroids, or are using other NSAIDs (like aspirin or naproxen).

It's important to stop using ibuprofen and consult a doctor if you notice signs of stomach bleeding, such as fainting, vomiting blood, or having black or bloody stools. Other reasons to seek medical advice include worsening stomach pain, lack of relief after 24 hours, or if fever or pain persists for more than three days. Always consult a doctor before use if there are existing health issues, especially related to the stomach, heart, or kidneys, or if other medications are being taken. Long-term use of ibuprofen may also increase the risk of heart attack or stroke.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters, stop using the medication and seek medical help immediately. Additionally, ibuprofen may lead to stomach bleeding, particularly 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. If your child has a severe or persistent sore throat, especially with high fever, headache, nausea, or vomiting, consult a doctor right away.

Before giving ibuprofen to your child, it's important to talk to a doctor if they have any history of serious side effects from pain relievers, stomach issues, bleeding problems, or conditions like high blood pressure, heart, or kidney disease. Always check with a healthcare professional if your child is taking other medications, especially NSAIDs or blood thinners. If you suspect an overdose, contact a medical professional or Poison Control Center immediately.

You should stop using ibuprofen and call your doctor if your child feels faint, vomits blood, has bloody or black stools, experiences worsening stomach pain, does not find relief within 24 hours, or if fever or pain lasts more than three days. Also, seek medical advice if you notice redness or swelling in the painful area or if any new symptoms arise.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious when it comes to your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen during pregnancy has not been established. In fact, ibuprofen is not recommended, especially during the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult your healthcare provider, as they may need to adjust the dosage or suggest alternative pain relief options. It's best to avoid using ibuprofen unless specifically directed by a medical professional. Your health and the health of your baby are the top priority, so always seek guidance when it comes to medication during pregnancy.

Lactation Use

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

If you do take ibuprofen while nursing, keep an eye on your baby for any unusual reactions or side effects. Your healthcare provider can help you weigh the benefits and risks to ensure both you and your infant stay healthy.

Pediatric Use

When considering medication for your child, it's important to follow specific guidelines based on their age and weight. For children aged 6 months to 23 months, the recommended doses are 1.25 mL for those weighing between 12-17 lbs (6-11 months) and 1.875 mL for those weighing 18-23 lbs (12-23 months). If your child is under 6 months, you should consult a doctor before giving any medication.

It's crucial not to use this medication in children under 3 years old unless a doctor specifically advises it for a sore throat. Always adhere to the recommended dosage and do not exceed 10 days of use unless directed by a healthcare professional. If necessary, doses can be repeated every 6-8 hours, but do not give more than four doses in a day. Additionally, consult your doctor before use if your child has any serious health issues or is taking other medications.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about its effects or safety for this age group. This means that if you or a loved one is an older adult, it's especially important to consult with a healthcare provider before starting the medication. They can help assess any potential risks and determine the best approach for your individual health needs. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If your child has kidney problems or heart disease, it's important to consult with a doctor before using this medication. Additionally, if your child has experienced significant fluid loss from vomiting or diarrhea, or if they haven't been drinking enough fluids, you should also seek medical advice. These precautions help ensure your child's safety and well-being while using the medication.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be cautious when giving ibuprofen to your child, especially if they are also taking other medications. Ibuprofen can increase the risk of stomach bleeding, particularly if your child is on blood thinners (medications that prevent blood clots) or steroids (medications that reduce inflammation). Additionally, if your child is taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen, the risk of stomach bleeding can be even higher.

Before giving ibuprofen, make sure to consult with your healthcare provider or pharmacist if your child is taking any other NSAIDs, blood thinners, or steroids. This will help ensure their safety and avoid any potentially serious interactions. Always prioritize open communication about all medications your child is taking.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to check the printed neckband; do not use the product if it is broken or missing, as this could compromise its safety. Additionally, make sure to look at the bottom of the box for the lot number and expiration date to confirm that the product is still valid for use.

By following these simple storage and handling guidelines, you can help ensure that your product remains effective and safe for your needs.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. If your child experiences stomach upset, it's best to give the medication with food or milk.

Be aware that long-term use may increase the risk of serious issues like heart attack or stroke. If your child shows any concerning symptoms—such as feeling faint, vomiting blood, having bloody or black stools, worsening stomach pain, or if they do not feel better within 24 hours—stop the medication and consult a doctor. Additionally, if fever or pain worsens or lasts more than 3 days, or if there is redness or swelling in the painful area, seek medical advice. Always pay attention to any new symptoms that may arise.

FAQ

What is Infants' Ibuprofen Oral Suspension used for?

Infants' Ibuprofen Oral Suspension 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 (12-17 lbs), the dosage is 1.25 mL. For infants aged 12-23 months (18-23 lbs), the dosage is 1.875 mL. Always consult a doctor for children under 6 months.

How often can I give Infants' Ibuprofen?

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

Are there any warnings associated with Infants' Ibuprofen?

Yes, it may cause severe allergic reactions, stomach bleeding, and should not be used if the child has had an allergic reaction to other pain relievers. Consult a doctor if the child has certain health conditions.

Can I use Infants' Ibuprofen if my child is pregnant or breastfeeding?

The safety of ibuprofen during pregnancy has not been established, and it is contraindicated in the third trimester. Nursing mothers should consult a doctor before use due to potential effects on the infant.

What should I do if my child experiences side effects?

Stop using the product and consult a doctor if your child feels faint, vomits blood, has bloody or black stools, or if any new symptoms appear.

How should I store Infants' Ibuprofen?

Store Infants' Ibuprofen at 20-25°C (68-77°F) and do not use if the printed neckband is broken or missing.

Packaging Info

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

Packaging configurations for Health Sense Infants Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Infants' Ibuprofen Oral Suspension is a concentrated formulation designed for pain relief and fever reduction, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each 1.25 mL dose contains 50 mg of ibuprofen, suitable for infants aged 6 months to 23 months. The suspension provides relief that lasts up to 8 hours and is alcohol-free. It is intended for use with the enclosed syringe for accurate dosing. The product is flavored with berry to enhance palatability and is comparable to the active ingredient found in Motrin® Infants' Drops.

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 use in pediatric patients and should not be administered to adults without specific medical guidance. Healthcare professionals are advised to adhere strictly to the following dosage and administration instructions.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference. It is imperative to measure the dose using the dosing device included with the product; the use of any other measuring device is not recommended.

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 necessary, but should not exceed four doses in a 24-hour period. The total duration of treatment should not exceed 10 days unless otherwise directed by a healthcare professional.

Dosing Chart:

  • For patients under 6 months of age, consultation with a doctor is required prior to administration.

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

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

It is crucial to ensure that the dosage does not exceed the specified limits and to monitor the patient for any adverse reactions during the course of treatment.

Contraindications

Use is contraindicated in the following situations:

Patients with a history of allergic reactions to any pain reliever or fever reducer should not use this product, as it may precipitate a severe allergic response. Additionally, the product is contraindicated for use immediately before or after heart surgery due to potential complications associated with surgical recovery and medication interactions.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of stomach bleeding. The likelihood of this adverse effect is increased in children who have a history of stomach ulcers or bleeding problems, are concurrently taking blood thinners (anticoagulants) or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of use.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of this medication should not exceed two days, nor should it be administered to children under three years of age unless directed by a healthcare provider.

Before administering ibuprofen, it is advisable to consult a physician if the child has any of the following conditions: a history of problems or serious side effects from pain relievers or fever reducers, ongoing stomach issues such as heartburn or stomach pain, ulcers, bleeding disorders, dehydration, high blood pressure, heart or kidney disease, or if they are taking diuretics. Additionally, consultation with a healthcare professional is recommended if the child is currently taking any other NSAID (whether prescription or over-the-counter), blood thinners, or steroid medications, is under medical care for any serious condition, or is taking any other medications.

In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is advised.

Parents or caregivers should discontinue use and contact a physician if the child experiences any of the following: faintness, vomiting of blood, or the presence of bloody or black stools, which may indicate stomach bleeding; worsening or persistent stomach pain; lack of relief within the first 24 hours of treatment; fever or pain that worsens or persists beyond three days; redness or swelling in the affected area; or the emergence of any new symptoms.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Additionally, ibuprofen carries a warning for potential stomach bleeding, which is more likely to occur in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs.

Patients should be advised to discontinue use and consult a healthcare provider if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, or passing bloody or black stools. Other concerning symptoms that warrant medical attention include worsening stomach pain or upset, lack of relief within the first 24 hours of treatment, persistent fever or pain lasting more than three days, redness or swelling in the painful area, or the emergence of new symptoms.

Common adverse reactions may include gastrointestinal discomfort, and patients should be cautious if they have a history of stomach issues, such as heartburn or ulcers, or if they are experiencing dehydration due to vomiting or diarrhea. It is also important for patients to consult a healthcare provider before using ibuprofen if they have high blood pressure, heart or kidney disease, or if they are taking diuretics or other medications that may interact with NSAIDs.

Long-term continuous use of ibuprofen may increase the risk of serious cardiovascular events, including heart attack or stroke. Therefore, patients should be monitored closely for any signs of these serious conditions, especially during prolonged treatment.

Drug Interactions

Ibuprofen has the potential to cause gastrointestinal bleeding, particularly in pediatric patients who are concurrently using anticoagulants or steroid medications. The risk of such adverse effects is further elevated when ibuprofen is administered alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin and naproxen.

It is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to the administration of ibuprofen if the child is currently taking any other NSAID, whether prescription or over-the-counter. Additionally, a consultation is advised before use if the child is on anticoagulant therapy or steroid medications to ensure safe and effective treatment.

Packaging & NDC

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

Packaging configurations for Health Sense Infants Ibuprofen.
Details

Pediatric Use

Pediatric patients aged 6 months to 23 months may receive this medication with specific dosing guidelines. For infants under 6 months, consultation with a doctor is required prior to use. For those weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL, while children weighing 18-23 lbs (12-23 months) should receive 1.875 mL.

This medication is not indicated for children under 3 years of age unless specifically directed by a healthcare professional for sore throat management. It is essential to adhere to the recommended dosing schedule, with a maximum of four doses per day, and doses may be repeated every 6-8 hours as needed. Treatment should not exceed 10 days unless advised by a doctor.

Healthcare professionals should advise parents or caregivers to consult a doctor before administering this medication if the child has a history of adverse reactions to pain relievers or fever reducers, gastrointestinal issues, ulcers, bleeding disorders, dehydration, hypertension, heart or kidney disease, or if the child is taking other medications.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that may affect treatment outcomes in this population.

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, including cardiovascular effects. Pregnant individuals should avoid using ibuprofen unless directed by a healthcare professional. Dosage modifications may be necessary for pregnant patients, and it is advised to consult a healthcare provider before use to ensure appropriate management and minimize risks to fetal outcomes.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen 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 ibuprofen.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a history of heart or kidney disease. Additionally, it is important to seek medical advice if the patient has experienced significant fluid loss due to vomiting or diarrhea, or if there is a concern regarding adequate fluid intake. Monitoring and appropriate dosing adjustments may be necessary in these situations to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of 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 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 noted, particularly in children with a history of stomach ulcers or bleeding problems, as well as in those taking anticoagulants, steroid drugs, or other nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, long-term continuous use of the medication may be associated with an increased risk of heart attack or stroke.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used if the child has a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Patients should be instructed to stop use and consult a doctor if the child experiences faintness, vomits blood, or has bloody or black stools, as these may indicate stomach bleeding. They should also be advised to discontinue use and seek medical advice if stomach pain or upset worsens or persists. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than three days, patients should be encouraged to contact a healthcare professional. Furthermore, any presence of redness or swelling in the painful area, or the emergence of new symptoms, should prompt a consultation with a doctor.

When administering this product, it is recommended to give it with food or milk if stomach upset occurs. Patients should be made aware that long-term continuous use may increase the risk of heart attack or stroke.

Before using this product, healthcare providers should advise patients to consult a doctor if the child has experienced problems or serious side effects from pain relievers or fever reducers, or if they have ongoing stomach issues such as heartburn, upset stomach, or stomach pain. It is also important to seek medical advice if the child has ulcers, bleeding problems, or has not been drinking fluids, especially if they have lost a significant amount of fluid due to vomiting or diarrhea.

Patients should be encouraged to consult a doctor before use if the child has high blood pressure, heart or kidney disease, or if they have taken a diuretic. Additionally, healthcare providers should recommend that patients speak with a doctor or pharmacist before using this product if the child is taking any other drug containing an NSAID, a blood-thinning (anticoagulant) or steroid drug, or if the child is under a doctor’s care for any serious condition.

Storage and Handling

The product is supplied in packaging that includes a printed neckband. It is essential to ensure that the neckband is intact; do not use the product if the neckband is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Users are advised to check the bottom of the box for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with the option to repeat doses every 6-8 hours as needed, not exceeding four doses per day. It is recommended to take the medication with food or milk to mitigate potential stomach upset.

Clinicians should counsel patients on the risks associated with long-term continuous use, which may elevate the risk of heart attack or stroke. Patients should be advised to discontinue use and consult a healthcare professional if they experience symptoms such as fainting, vomiting blood, or having bloody or black stools, as these may indicate stomach bleeding. Additionally, they should seek medical advice if stomach pain worsens or persists, if there is no relief within the first 24 hours, if fever or pain intensifies or lasts beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Drug Information (PDF)

This file contains official product information for Health Sense 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 Health Sense 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.

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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.