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Parents Choice Infants Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
April 7, 2025
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 2017
Label revision date
April 7, 2025
Manufacturer
Wal-Mart Stores Inc
Registration number
ANDA075217
NDC root
49035-601
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

Parent’s CHOICE™ Infants’ Ibuprofen Concentrated Drops is a liquid medication designed for infants aged 6 to 23 months. It contains ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID) that helps reduce fever and relieve minor aches and pains associated with common conditions like colds, flu, sore throats, headaches, and toothaches.

This formulation is berry-flavored and comes in a concentrated dose of 50 mg per 1.25 mL, providing effective relief that can last up to 8 hours. It is also free from high fructose corn syrup, gluten, and dyes, 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 is effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

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

Dosage and Administration

Before using this product, it's important to note that it does not come with complete directions or warnings for adults. Always make sure to follow the recommended dosage and never give more than directed. To prepare the medication, shake the bottle well before use. You can find the right dose by referring to the dosing chart, which suggests using your child's weight for the most accurate measurement. If weight isn't available, you can use their age instead.

When measuring the dose, use the dosing device that comes with the product, as other devices may not provide accurate measurements. For administration, slowly dispense the liquid into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to exceed four doses in a single day. For infants under 6 months, it's best to consult a doctor before giving any medication.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

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

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening. This risk is heightened if the medication is used in higher doses or for longer than recommended. If your child experiences symptoms such as faintness, vomiting blood, or severe stomach pain, or if they show signs of heart problems like chest pain or difficulty breathing, seek medical attention immediately. Always consult a doctor if your child has a history of stomach issues, is dehydrated, or has other serious health conditions before using ibuprofen.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding 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 notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they 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 safety is the top priority.

Pregnancy Use

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

Before taking ibuprofen, you should consult with your healthcare provider to discuss any concerns and explore safer alternatives for pain relief or inflammation management during pregnancy. Your health and the health of your baby are the top priority, so always seek professional advice when considering medication.

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

Pediatric Use

It's important to be cautious when using this medication in children. You should not give it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 6 months to 23 months, the dosage varies based on their weight, so it's best to consult a doctor for guidance if your child is under 6 months old.

If your child has any history of stomach issues, high blood pressure, heart disease, liver or kidney problems, asthma, or is taking certain medications like diuretics, you should consult a doctor before use. Additionally, do not use this medication for more than 2 days, and if your child shows any signs of stomach bleeding or does not find relief within 24 hours, stop using it and seek medical advice immediately.

Geriatric Use

When it comes to using Parent's Choice Infants' Ibuprofen, there are no specific guidelines or dosage adjustments for older adults mentioned in the drug insert. This means that, based on the information available, elderly patients do not face unique safety concerns related to this medication.

However, it's always important to consult with a healthcare provider before starting any new medication, especially for older adults who may have other health conditions or be taking multiple medications. Your healthcare provider can help ensure that this medication is safe and appropriate for your specific situation.

Renal Impairment

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

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

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

Drug Interactions

It's important to be aware of potential interactions when using ibuprofen. If you or your child are allergic to aspirin, taking ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Using ibuprofen can also raise the chances of serious heart issues, like heart attack or stroke, especially if it's taken in higher doses or for longer than recommended. Always consult with a healthcare provider or pharmacist before starting ibuprofen or any new medication, particularly if other drugs are being taken. This ensures safety and helps prevent any harmful interactions.

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. Before using, always check that the printed neckband is intact; do not use the product if the neckband is broken or missing, as this could compromise safety.

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

Additional Information

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

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

FAQ

What is Parent’s CHOICE™ Infants’ Ibuprofen Concentrated Drops used for?

It 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 aged 6 to 23 months?

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

How often can I give this medication?

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 this medication?

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

Can I use this medication if my child is under 3 years old?

Do not use in children under 3 years of age unless directed by a doctor.

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

Stop use immediately and consult a doctor if your child feels faint, vomits blood, or has bloody or black stools.

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.

What should I do in case of an overdose?

Get medical help or contact a Poison Control Center right away at 1-800-222-1222.

How should I store Parent’s CHOICE™ Infants’ Ibuprofen?

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

Packaging Info

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

Packaging configurations for Parents Choice Infants Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen Oral Suspension is a non-steroidal anti-inflammatory drug (NSAID) formulated to provide pain relief and reduce fever. Each 1.25 mL of the suspension contains 50 mg of ibuprofen. The product is designed for oral administration and is presented in a 1 fluid ounce (30 mL) bottle.

This formulation is characterized by its non-staining properties and is free from high fructose corn syrup and gluten. It is dye-free and features a berry flavor to enhance palatability. The suspension is intended for use with the enclosed syringe to ensure accurate dosing. The effects of the medication can last up to 8 hours.

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, dosing should be based on the child's weight; if weight is not available, age may be used as a guide.

Dosing should be measured using the dosing device provided with the product; other devices should not be used to ensure accurate dosing. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek to facilitate swallowing.

If necessary, the dose may be repeated every 6 to 8 hours, but it is important not to exceed 4 doses in a 24-hour period.

Dosing Chart:

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

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

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

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

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. Furthermore, ibuprofen should not be administered for more than two days or to children under three years of age unless directed by a healthcare provider.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain; symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling; lack of relief within the first 24 hours of treatment; worsening fever or pain lasting more than three days; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention is required. Patients should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

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

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

The use of ibuprofen is associated with an increased risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk of stomach bleeding is heightened if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for longer than directed.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting, and should seek medical attention promptly. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's guidance.

Patients are instructed to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, if a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation with a healthcare professional.

Before using ibuprofen, it is essential for patients to consult a doctor 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. Patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical advice prior to use. Additionally, patients with asthma or those taking diuretics should consult a healthcare provider before using this medication.

Lastly, it is recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare professional or pharmacist prior to using ibuprofen.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that may impact patient safety and treatment efficacy.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is advisable for healthcare providers to assess the patient's allergy history before prescribing ibuprofen.

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is further elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is recommended in patients receiving these combinations.

Cardiovascular Risks The use of ibuprofen has been linked to an increased risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. Clinicians should consider these risks when prescribing ibuprofen, especially in patients with pre-existing cardiovascular conditions.

General Recommendations Healthcare providers should advise patients or caregivers to consult with a doctor or pharmacist prior to administering ibuprofen if the child is taking any other medications. This precaution helps to ensure safe and effective use of ibuprofen in conjunction with other therapies.

Packaging & NDC

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

Packaging configurations for Parents Choice Infants Ibuprofen.
Details

Pediatric Use

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

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic. Additionally, consultation is recommended if the child is under a doctor's care for any serious condition.

The medication should not be used for more than 2 days, and if the child experiences any signs of stomach bleeding—such as feeling faint, vomiting blood, or having bloody or black stools—use should be discontinued immediately, and a doctor should be consulted. If the child does not experience relief within the first 24 hours of treatment, parents should also stop use and seek medical advice.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns outlined in the prescribing information for Parent's Choice Infants' Ibuprofen. Therefore, healthcare providers may not need to implement any additional precautions or modifications when prescribing this medication to geriatric patients. However, as with any medication, it is advisable to monitor elderly patients for any potential adverse effects or interactions, given the variability in pharmacokinetics and pharmacodynamics that can occur with aging.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Women of childbearing potential should consult a healthcare provider before using ibuprofen if they are pregnant or planning to become pregnant to discuss the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in lactating mothers. Additionally, there is no mention of the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to assess the safety and efficacy of the treatment. It is essential to evaluate liver enzymes and other relevant laboratory parameters regularly to ensure that the medication is well-tolerated and to mitigate the risk of adverse effects.

Additionally, patients with a history of significant comorbidities such as high blood pressure, heart disease, kidney disease, or a history of stroke should be monitored closely, as these conditions may further complicate the management of their hepatic impairment.

Healthcare providers should exercise caution and consider these factors when determining the appropriate therapeutic approach for patients with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing potential overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical scenario.

Nonclinical Toxicology

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

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should encourage patients to consult a doctor prior to use if the child has a history of stomach issues, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to discuss the child's history of serious side effects from pain relievers or fever reducers.

Patients should be instructed to inform their healthcare provider if the child has not been adequately hydrated or has experienced significant fluid loss due to vomiting or diarrhea. Furthermore, it is essential to ask about any pre-existing conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as these may influence the safety of the medication.

Providers should also inquire if the child has asthma or is currently taking a diuretic. It is advisable to recommend that patients consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Care must be taken to ensure that the product is not frozen, as freezing may compromise its quality. Additionally, the product should not be used if the printed neckband is broken or missing, as this may indicate tampering or damage. Proper handling and storage conditions are essential to ensure the product remains safe and effective for use.

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 exceed four doses in a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted 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 Parents Choice 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 Parents Choice 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.