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Foster and Thrive Infants Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
July 12, 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
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
July 12, 2024
Manufacturer
Strategic Sourcing Services LLC
Registration number
ANDA075217
NDC root
70677-1144
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

Ibuprofen is a medication designed for infants aged 6 months to 23 months, available in a concentrated oral suspension with a pleasant berry flavor. It serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headaches, and toothaches.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen works by reducing inflammation and lowering fever, providing relief that can last up to 8 hours. This product is paraben-free and gluten-free, making it a suitable option for many families.

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 exceed the amount directed. To prepare the medication, shake the bottle well before each use.

To find the right dose for your child, refer to the dosing chart based on their weight. If possible, use your child's weight for dosing; if not, you can use their age. For example, if your child weighs between 12-17 pounds and is 6-11 months old, the dose is 1.25 mL. If they weigh between 18-23 pounds and are 12-23 months old, the dose is 1.875 mL. Always measure the dose using the dosing device provided, as other devices may not be accurate. When giving the liquid, dispense it slowly into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6-8 hours, but do not give more than four doses in a single day.

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 it right before or after heart surgery, as this could pose serious risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of a severe 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 are also warnings regarding heart attack and stroke, as NSAIDs (excluding aspirin) can increase these risks, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always check with a healthcare professional if your child has any underlying health conditions 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, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than three days, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, using ibuprofen during pregnancy, especially in the third trimester, is not recommended because it can harm the developing fetus. Potential risks include cardiovascular problems and kidney issues for the baby.

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 best options for managing any discomfort you may experience.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it's important to consult your doctor first. While ibuprofen can be helpful for pain relief, there is a possibility that it can pass into your breast milk. The effects of ibuprofen on nursing infants haven't been thoroughly studied, so it's wise to be cautious.

If you do take ibuprofen while breastfeeding, keep an eye on your baby for any unusual reactions or side effects. Monitoring your infant can help ensure their safety while you manage your own discomfort.

Pediatric Use

You should avoid using this medication in children under 3 years old unless a doctor specifically advises it. For children between 6 to 23 months, the dosage varies based on weight: if your child weighs between 12-17 pounds, the dose is 1.25 mL, and for those weighing 18-23 pounds, the dose is 1.875 mL. Always consult a doctor before giving this medication if your child has had an allergic reaction to ibuprofen or any other pain reliever.

It's important to be cautious if your child has a history of stomach issues, such as heartburn, or if they have conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. If your child has been vomiting or has diarrhea and isn't drinking fluids, or if they show any signs of stomach bleeding or heart problems, seek medical advice immediately. Additionally, if your child does not feel better within 24 hours or if their fever or pain worsens or lasts more than 3 days, contact a doctor.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare provider for personalized advice, as they can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with medical professionals to ensure safe and effective use of any medication.

Renal Impairment

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

Hepatic Impairment

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

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

Drug Interactions

It's important to be aware of how ibuprofen can interact with other medications. For instance, if you take blood thinners (medications that help prevent blood clots) or steroids, using ibuprofen may increase your risk of stomach bleeding. Additionally, taking ibuprofen, especially in higher doses or for extended periods, can raise the chances of serious heart issues like heart attack or stroke. You should also avoid using ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, as this can lead to further complications.

Always discuss any medications you are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, check the printed neckband before use; do not use it if the neckband is broken or missing, as this could compromise safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

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

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

FAQ

What is Ibuprofen used for?

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

What is the recommended dosage for children?

For children aged 6-11 months weighing 12-17 lbs, the dose is 1.25 mL. For children aged 12-23 months weighing 18-23 lbs, the dose is 1.875 mL.

How often can I give Ibuprofen to my child?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I use Ibuprofen if my child is allergic to aspirin?

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

Is it safe to use Ibuprofen during pregnancy?

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

What should I do if my child experiences side effects?

If your child shows signs of stomach bleeding, heart problems, or does not get relief within 24 hours, stop use and consult a doctor immediately.

How should I store Ibuprofen?

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

Can nursing mothers use Ibuprofen?

Nursing mothers should consult a doctor before using Ibuprofen, as it may be excreted in breast milk and its effects on nursing infants are not well studied.

Packaging Info

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

Packaging configurations for Foster and Thrive Infants Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is an oral suspension formulated to provide pain relief and reduce fever. Each 1.25 mL dose contains 50 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). The product is designed for a duration of action lasting up to 8 hours. It is presented in a 0.5 fluid ounce (15 mL) container and features a berry flavor. The formulation is free from parabens and gluten. Administration is recommended exclusively 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 (6-11 months of age), the recommended dose is 1.25 mL.

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

Contraindications

Use is contraindicated in the following situations:

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

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 taking anticoagulants or steroid medications, and individuals using 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 used for more than two days in such instances, nor should it be administered to children under three years of age unless specifically directed by a physician.

Healthcare providers should instruct caregivers to discontinue ibuprofen and seek medical advice if the child exhibits any signs of stomach bleeding, including faintness, vomiting blood, passing bloody or black stools, or persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as 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, medical consultation is necessary. Any new or unusual symptoms should also prompt a discussion with a healthcare professional.

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

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential 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. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

There is also a significant risk associated with the use of NSAIDs, excluding aspirin, for 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 duration.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's direction.

Parents and caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if the child does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

Before administering ibuprofen, it is crucial to consult a doctor if the child has a history of stomach issues, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, children with asthma or those taking diuretics should seek medical advice prior to use. Caregivers should also consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen may interact with various medications, leading to significant clinical effects.

Pharmacodynamic Interactions:

  • Anticoagulants and Steroids: The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider alternative pain management strategies if necessary.

  • Other NSAIDs: Ibuprofen should not be administered alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. The combined use of these agents can increase the risk of adverse effects, particularly gastrointestinal complications.

Pharmacokinetic Interactions:

  • Cardiovascular Risks: The use of ibuprofen, particularly at higher doses or for extended periods, may heighten the risk of serious cardiovascular events, including heart attack, heart failure, and stroke. Clinicians should evaluate the necessity of ibuprofen therapy in patients with existing cardiovascular conditions and consider dosage adjustments or alternative therapies as appropriate.

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

Packaging & NDC

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

Packaging configurations for Foster and Thrive 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: for children weighing 12-17 lbs (approximately 6-11 months of age), the recommended dose is 1.25 mL; for those weighing 18-23 lbs (approximately 12-23 months of age), the dose is 1.875 mL.

Prior to administration, it is essential to consult a doctor if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Caution is advised for children with a history of stomach problems, such as heartburn, as they may be at increased risk for stomach bleeding. Additionally, consultation with a healthcare provider is recommended if the child has not been adequately hydrated due to vomiting or diarrhea, or if there are pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke.

Children with asthma or those taking diuretics should also seek medical advice before use. Parents or caregivers should discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, symptoms indicative of heart problems or stroke, does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 pose risks to the fetus, including potential cardiovascular issues and renal impairment. Pregnant women should consult a healthcare provider before using ibuprofen, especially if they are in the later stages of pregnancy.

Lactation

Nursing mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen 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 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 therapy in individuals with reduced kidney function. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

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

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects that may arise from the medication's use in this population.

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 symptoms 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 procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure safety and effectiveness of the treatment provided.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with ibuprofen use. Reports of allergic reactions have included hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems. There is also an increased risk of cardiovascular events, such as heart attack, heart failure, and stroke, especially in patients using higher doses or for extended durations beyond the recommended guidelines.

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 discuss the child's fluid intake; patients should be advised to seek medical advice if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea.

Healthcare providers should also inquire about the child's medical history, specifically if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has experienced a stroke. It is crucial to ask about asthma and the use of diuretics, as these conditions may require special consideration before administering the medication.

Furthermore, patients should be encouraged to consult a doctor or pharmacist if the child is under medical care for any serious condition or if the child is taking any other medications. This ensures a comprehensive evaluation of potential interactions and contraindications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and effectiveness.

Healthcare professionals are advised to inspect the product prior to use. The product should not be utilized if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial to ensure the product's quality and efficacy.

Additional Clinical Information

The medication is administered orally, with clinicians advised to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. If necessary, the dose may be repeated every 6 to 8 hours, but it should not be administered more than four times a day.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, it is crucial 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 Foster and Thrive 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 Foster and Thrive 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.