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Pediacare Childrens Ibuprofen Berry

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Active ingredient
Ibuprofen 100 mg/5 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 2023
Label revision date
December 20, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 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 2023
Label revision date
December 20, 2022
Manufacturer
RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH
Registration number
ANDA210602
NDC root
52412-910
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

Children's Ibuprofen is an oral suspension specifically designed for children aged 2 to 11 years. This medication is a nonsteroidal anti-inflammatory drug (NSAID) that helps relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it effectively reduces fever, providing comfort for your child when they are feeling unwell.

With a pleasant original berry flavor, Children's Ibuprofen is formulated to last up to 8 hours, making it a convenient option for managing your child's pain and fever. Each 5 mL dose contains 100 mg of ibuprofen, ensuring that it is both effective and easy for kids to take.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before using this product, make sure to shake it well. It's important to follow the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age. For example, if your child weighs between 24-35 pounds and is 2-3 years old, the dose is 5 mL. If they weigh between 36-47 pounds and are 4-5 years old, the dose increases to 7.5 mL.

You can repeat the dose every 6 to 8 hours if needed, but remember not to exceed 4 doses in a single day. If your child is under 24 pounds or under 2 years old, it's best to consult a doctor for the appropriate dosage. Always ensure you do not give more than directed.

What to Avoid

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

Side Effects

Ibuprofen can cause serious allergic reactions, 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 risks associated with NSAIDs, which can be life-threatening. Symptoms that require immediate medical attention include severe or persistent sore throat with high fever, chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. If your child experiences any signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop use and consult a doctor right away. Always consult a healthcare professional if you have concerns about your child's health or if they are taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using it immediately and seek medical help. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that may lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs. Be cautious, as NSAIDs can also increase the risk of heart attack and stroke, especially if used in higher doses or for longer than recommended.

Before giving ibuprofen to your child, consult a doctor if they have had any allergic reactions to pain relievers, have stomach issues, or are experiencing dehydration from vomiting or diarrhea. It's also important to check with a healthcare professional if your child has high blood pressure, heart disease, or asthma. If your child shows signs of stomach bleeding (like fainting, vomiting blood, or having black stools) or symptoms of heart problems (such as chest pain or trouble breathing), stop the medication and call your doctor right away. For any overdose situation, 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

While the information provided does not specify any particular guidelines or risks associated with using ibuprofen during pregnancy, it is important to approach any medication with caution. Currently, there are no stated contraindications or dosage modifications for pregnant individuals regarding ibuprofen. However, since the insert does not mention any special precautions, it is advisable to consult with your healthcare provider before taking ibuprofen or any medication during pregnancy to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any concerns or questions you may have.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of ibuprofen on babies who are breastfed haven't been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

When giving this medication to your child, it's important to follow the dosing guidelines carefully. For children under 2 years old or weighing less than 24 pounds, consult a doctor before use. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. As your child grows, the dose increases based on their weight, reaching up to 15 mL for an 11-year-old weighing between 72 to 95 pounds. Remember, do not exceed the recommended dose, and avoid using it for more than two days for sore throats, especially in children under 3 years old, unless directed by a doctor.

Be cautious if your child has a history of stomach issues, is dehydrated, or has certain health conditions like high blood pressure or asthma. It's best to give the medication with food or milk if it causes stomach upset. If your child does not feel better within 24 hours, if symptoms worsen, or if new symptoms appear, stop using the medication and consult a doctor. Always prioritize your child's safety and well-being when administering any medication.

Geriatric Use

While there is no specific information about the use of Pediacare Children's Ibuprofen Berry in older adults, it's important to remember that this medication is primarily designed for children. If you are caring for an older adult, be cautious and consult a healthcare professional before using this product.

Since the insert does not provide guidelines or dosage adjustments for elderly patients, it’s essential to ensure that any medication taken is appropriate for their age and health status. Always prioritize safety and seek advice from a doctor or pharmacist if you have any concerns about medication use in older adults.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider needs to know about any existing conditions, such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these can affect how the medication works for you. Always prioritize open communication with your doctor to ensure your safety and the effectiveness of your treatment.

Hepatic Impairment

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

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

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using 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 serious stomach bleeding increases. This risk is also heightened if your child is taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with a healthcare provider if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and any lab tests with your doctor is crucial to ensure safety and avoid serious complications.

Storage and Handling

To ensure the safety and effectiveness 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 packaging before use; do not use the product if the carton is opened or if the printed neckband on the bottle is broken or missing. Additionally, make sure to look at the bottom panel 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 maintain the quality and safety of your product.

Additional Information

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

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension (NSAID) that provides pain relief and reduces fever for children aged 2-11 years.

How does Children's Ibuprofen work?

It relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it reduces fever.

What is the recommended dosage for Children's Ibuprofen?

The dosage depends on the child's weight and age. For example, a child weighing 24-35 lbs (2-3 years) should take 5 mL.

How often can I give Children's 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 Children's Ibuprofen?

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 certain health conditions.

What should I do if my child experiences side effects?

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

Can I use Children's Ibuprofen if my child has had an allergic reaction to ibuprofen before?

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

Is it safe to use Children's Ibuprofen during pregnancy?

The insert does not provide specific information regarding the use of ibuprofen during pregnancy, so consult a doctor.

What should I do in case of an overdose?

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

How should I store Children's Ibuprofen?

Store it between 20-25°C (68-77°F) and do not use if the carton is opened or the bottle neckband is broken or missing.

Packaging Info

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

Packaging configurations for Pediacare Childrens Ibuprofen Berry.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Pedia Care® is a children's ibuprofen oral suspension formulated specifically for pediatric use in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. The suspension is presented in a 4 FL OZ (118 mL) bottle and features an original berry flavor. The analgesic and antipyretic effects of this formulation can last up to 8 hours.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a physician for the appropriate dose. For patients weighing between 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL. For those weighing 36-47 lbs (ages 4-5 years), the dose is 7.5 mL. Patients weighing 48-59 lbs (ages 6-8 years) should receive 10 mL, while those weighing 60-71 lbs (ages 9-10 years) should be administered 12.5 mL. Finally, for patients weighing 72-95 lbs (age 11 years), the recommended dose is 15 mL.

Dosing may be repeated every 6-8 hours as needed, but it is crucial not to exceed 4 doses in a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions 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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries the risk of severe gastrointestinal bleeding. This risk is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), or those exceeding the recommended dosage or duration of treatment. Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with prolonged use or higher-than-recommended dosages.

Healthcare professionals should be vigilant for severe or persistent sore throat symptoms, particularly when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical evaluation. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age without a physician's directive.

General precautions must be observed. Ibuprofen should not be used in children with a prior allergic reaction to ibuprofen or any other pain reliever or fever reducer. It is contraindicated immediately before or after cardiac surgery. Prior to administration, healthcare providers should inquire about the following conditions: a history of stomach bleeding, previous gastrointestinal issues such as heartburn, adverse reactions to pain relievers or fever reducers, inadequate fluid intake, significant fluid loss due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, stroke history, asthma, or concurrent use of diuretics. Additionally, consultation with a physician or pharmacist is advised if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Healthcare professionals should instruct caregivers to discontinue ibuprofen and consult a physician if the child exhibits any signs of gastrointestinal 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, warrant immediate medical evaluation. If the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical consultation is necessary.

Side Effects

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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding, which 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, ibuprofen, or naproxen). The risk of stomach bleeding is also increased if the medication is taken in higher doses or for extended periods beyond the recommended duration.

Additionally, 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 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.

Parents and caregivers should discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing 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 the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation.

It is contraindicated to use ibuprofen in children with a history of allergic reactions to ibuprofen or other pain relievers/fever reducers, and it should not be administered immediately before or after heart surgery. Prior to use, it is essential to consult a healthcare provider 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 before using ibuprofen. Caregivers should also consult a doctor or pharmacist if the child is under treatment for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, there is an increased risk of severe gastrointestinal bleeding. This risk is also elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

It is advisable for caregivers to consult a healthcare professional if the child is concurrently taking a diuretic, as this may necessitate monitoring or dosage adjustments.

Packaging & NDC

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

Packaging configurations for Pediacare Childrens Ibuprofen Berry.
Details

Pediatric Use

Pediatric patients should not exceed the recommended dosage. The dosing chart is as follows:

  • Under 24 lbs / Under 2 years: Consult a doctor

  • 24-35 lbs / 2-3 years: 5 mL

  • 36-47 lbs / 4-5 years: 7.5 mL

  • 48-59 lbs / 6-8 years: 10 mL

  • 60-71 lbs / 9-10 years: 12.5 mL

  • 72-95 lbs / 11 years: 15 mL

For sore throat relief, this product should not be used for more than 2 days or administered to children under 3 years of age unless directed by a healthcare professional. Caution is advised due to the increased risk of stomach bleeding, particularly in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroids, or those using other NSAIDs.

Before use, it is essential to consult a doctor if the child has any of the following conditions: a history of stomach issues (e.g., heartburn), adverse reactions to pain relievers or fever reducers, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the child is taking a diuretic.

When administering this product, it is recommended to give it with food or milk if stomach upset occurs. Parents or caregivers should discontinue use and seek medical advice if the child does not experience relief within 24 hours, if fever or pain worsens or persists beyond 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Geriatric Use

Elderly patients may not have specific dosing or safety information provided for Pediacare Children's Ibuprofen Berry, as the drug insert primarily addresses pediatric dosing and warnings. Consequently, healthcare providers should exercise caution when considering the use of this medication in geriatric patients.

Due to the absence of data regarding dosage adjustments or safety considerations for elderly patients, it is advisable to monitor this population closely for any adverse effects or complications that may arise from the use of this medication. Careful assessment of the patient's overall health status and concurrent medications is recommended to ensure safe and effective use.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of ibuprofen during pregnancy. As such, healthcare professionals should consider the absence of specific data when advising pregnant patients on the use of ibuprofen.

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.

Renal Impairment

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

Hepatic Impairment

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

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

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic impairment.

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

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients with a history of stomach ulcers or bleeding problems, as well as those taking anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been noted as serious conditions that require prompt medical consultation.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important to emphasize that this medication should not be administered right before or after heart surgery.

Healthcare providers should counsel patients to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, patients should be advised to stop use and seek medical attention if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should also be informed that if the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days, they should stop use and consult a doctor. Any presence of redness or swelling in the painful area, or the emergence of new symptoms, should prompt a discussion with a healthcare provider.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is essential for patients to consult a doctor before use if the stomach bleeding warning applies to their child, or if the child has a history of stomach problems such as heartburn.

Healthcare providers should encourage patients to seek medical advice before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea. Additionally, patients should be advised to consult a doctor if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic.

Finally, patients should be reminded to 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 a secure carton, and it is essential to ensure that the carton remains unopened and that the printed bottle neckband is intact. If either of these conditions is not met, the product should not be used.

Storage conditions require that the product be maintained at a temperature between 20-25°C (68-77°F). For proper identification, the lot number and expiration date can be found on the bottom panel of the carton.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Pediacare Childrens Ibuprofen Berry, 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 Pediacare Childrens Ibuprofen Berry, 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.