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Childrens Ibuprofen Oral Suspension Original Berry Flavor

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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)
Marketed in the U.S.
Since 2024
Label revision date
December 27, 2025
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
Marketed in the U.S.
Since 2024
Label revision date
December 27, 2025
Manufacturer
Puro Pharma Inc.
Registration number
ANDA210602
NDC root
83474-002

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Drug Overview

PURO PHARMA Children's Ibuprofen Oral Suspension is a medication that contains ibuprofen, which is a type of nonsteroidal anti-inflammatory drug (NSAID). It is designed specifically for children aged 2 to 11 years and is used to relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever.

This oral suspension comes in a pleasant original berry flavor and provides relief that can last up to 8 hours. It is important to read all product information before use to ensure it is appropriate for your child.

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 you use this medication, make sure to shake the bottle well. To find the right dose for you or your child, refer to the dosing chart provided. If possible, use weight to determine the dose; if not, you can use age. It's important to use only the enclosed dosing cup to measure the medication—other devices may not provide the correct amount.

For children weighing under 24 pounds (or under 2 years old), you should consult a doctor before administering any dose. For those weighing between 24 and 35 pounds (ages 2-3), the dose is 5 mL. If your child weighs 36 to 47 pounds (ages 4-5), the dose increases to 7.5 mL. For children weighing 48 to 59 pounds (ages 6-8), the dose is 10 mL, and for those weighing 60 to 71 pounds (ages 9-10), the dose is 12.5 mL. Finally, if your child weighs 72 to 95 pounds (around 11 years old), the dose is 15 mL. You can repeat the dose every 6 to 8 hours if needed, but do not exceed four doses in a single day. Always follow your doctor’s instructions if they provide specific guidance.

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

Side Effects

Ibuprofen can cause serious side effects, and it's important to be aware of them. You may experience a severe allergic reaction, especially if you are allergic to aspirin. Symptoms can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. If you notice any of these signs, stop using ibuprofen and seek medical help immediately.

Additionally, ibuprofen can 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). There is also an increased risk of heart attack and stroke with NSAIDs, especially if used in higher doses or for longer than recommended. If you or your child experience symptoms like faintness, vomiting blood, chest pain, or trouble breathing, contact a doctor right away. Always consult a healthcare professional if symptoms worsen or do not improve within a few days.

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 are under three years old. 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

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not provide specific guidance on its use. There are no stated risks or contraindications associated with taking ibuprofen while pregnant, and the insert does not mention any necessary dosage adjustments for pregnant individuals. Additionally, there are no special precautions outlined for its use during this time.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

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

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

Pediatric Use

It's important to be cautious when using this product for children. You should not use it in children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight. For example, if your child weighs under 24 lbs and is under 2 years old, consult a doctor first. For children weighing 24-35 lbs (ages 2-3), the recommended dose is 5 mL, while those weighing 36-47 lbs (ages 4-5) should take 7.5 mL. The dosage increases with weight, reaching 15 mL for an 11-year-old weighing 72-95 lbs.

Always consult a doctor if your child has a history of stomach issues, is being treated for a serious condition, or is taking other medications. If you notice any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the product immediately and seek medical advice. Remember, this product is specifically designed for children, and the instructions do not cover adult use.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your liver condition, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using this medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 keep the carton sealed and intact; do not use the product if the carton is opened or if the printed neckband on the bottle is broken or missing. This helps maintain the product's integrity and ensures your safety during use. Always handle the product with care to avoid any contamination or damage.

Additional Information

No further information is available.

FAQ

What is PURO PHARMA Children's Ibuprofen Oral Suspension used for?

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

What is the recommended dosage for children?

The dosage varies by weight: for example, children weighing 24-35 lbs (2-3 years) should take 5 mL, while those weighing 72-95 lbs (11 years) should take 15 mL.

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, has bloody or black stools, or has stomach pain that does not improve.

Is it safe to use this product in children under 3 years of age?

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

What are the potential allergic reactions to ibuprofen?

Ibuprofen may cause severe allergic reactions, including hives, facial swelling, and asthma. If an allergic reaction occurs, seek medical help immediately.

How should I administer the medication?

Shake well before using and use only the enclosed dosing cup. If stomach upset occurs, take with food or milk.

What should I do if my child does not get relief within 24 hours?

Consult a doctor if your child does not experience relief within the first day of treatment.

Can nursing mothers use this product?

Nursing mothers should consult a doctor before using this product, as ibuprofen may be excreted in breast milk.

What are the storage instructions for this medication?

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

Who manufactures PURO PHARMA Children's Ibuprofen?

It is manufactured by Puro Pharma Inc., located at 42 Catharine St. Poughkeepsie, NY 12601.

Packaging Info

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

Packaging configurations for Childrens Ibuprofen Oral Suspension Original Berry Flavor.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Ibuprofen Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) formulated to provide relief from pain and fever in children. Each 5 mL of the suspension contains 100 mg of ibuprofen. The product is presented in a 4 FL OZ (118 mL) bottle and features an original berry flavor to enhance palatability for pediatric patients.

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

The medication should be shaken well before use. Healthcare professionals are advised to determine the appropriate dose using the provided dosing chart, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure. It is imperative to utilize only the enclosed dosing cup for administration, as other dosing devices may lead to inaccuracies.

Dosing intervals may be repeated every 6 to 8 hours as necessary, with a maximum of four doses administered within a 24-hour period. The dosing chart is as follows:

  • For patients weighing under 24 lbs (under 2 years), consultation with a physician is recommended.

  • For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

  • For patients weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lbs (6-8 years), the recommended dose is 10 mL.

  • For patients weighing 60-71 lbs (9-10 years), the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

Dosing may also be adjusted as directed by a physician.

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 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 taking anticoagulants or steroid medications, or those concurrently using other NSAIDs (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases the risk of stomach bleeding.

NSAIDs, with the exception of 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. Patients should be advised not to use ibuprofen for more than two days or to administer it to children under three years of age without medical guidance.

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 suggestive 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 cases of overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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

The use of ibuprofen is also associated with a risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, or those using other NSAIDs concurrently. Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should stop use and consult a healthcare provider if any of these symptoms occur.

Additionally, ibuprofen carries warnings regarding an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should be vigilant for symptoms of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include gastrointestinal discomfort, and patients should be advised to seek medical attention if fever or pain worsens or persists beyond three days, if there is no relief within the first 24 hours of treatment, or if any new symptoms arise.

Furthermore, a severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition requiring prompt medical evaluation. It is recommended that ibuprofen not be used for more than two days in such cases or administered to children under three years of age unless directed by a healthcare professional.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Childrens Ibuprofen Oral Suspension Original Berry Flavor.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this product unless directed by a doctor. For dosing, the following guidelines apply based on weight and age:

  • For children weighing under 24 lbs and under 2 years of age, consultation with a doctor is advised.

  • For those weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL.

  • For children weighing 36-47 lbs (ages 4-5 years), the recommended dose is 7.5 mL.

  • For children weighing 48-59 lbs (ages 6-8 years), the recommended dose is 10 mL.

  • For children weighing 60-71 lbs (ages 9-10 years), the recommended dose is 12.5 mL.

  • For children weighing 72-95 lbs (age 11 years), the recommended dose is 15 mL.

This product is specifically intended for use in children. Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, is under medical care for any serious condition, or is taking other medications. In the event of any signs of stomach bleeding or symptoms indicative of heart problems or stroke, use should be discontinued immediately, and a doctor should be consulted. It is important to note that the product does not contain directions or complete warnings for adult use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided information. The prescribing information does not mention any contraindications or risks associated with ibuprofen use during this period. Additionally, no dosage modifications for pregnant individuals are provided, nor does the insert include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

Renal Impairment

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

Hepatic Impairment

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

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 several adverse reactions associated with the use of the medication. Reports have included gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and serious skin reactions.

Gastrointestinal bleeding has been documented, with some cases classified as serious, necessitating hospitalization. Renal impairment has been observed particularly in patients with pre-existing kidney conditions or those experiencing dehydration. Additionally, hypersensitivity reactions, including instances of anaphylaxis and severe skin reactions, have been reported in the postmarketing setting.

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

It is essential to inform patients 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, patients should be cautioned against using this medication right before or after heart surgery.

Patients should be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If any of these symptoms occur, patients should be advised to stop use and consult a doctor.

Furthermore, patients should be informed to stop use and seek medical advice if the child exhibits symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. 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, patients should be instructed to consult a doctor. Redness or swelling in the painful area or the appearance of any new symptoms should also 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 important for patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies.

Patients should also be encouraged to seek medical advice 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 consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Lastly, patients should be advised to discuss with a doctor or pharmacist before use if the child is taking a diuretic or is under a doctor's care for any serious condition, as well as if the child 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.

For optimal storage, the product should be maintained at a temperature range of 20-25° C (68-77° F). Proper handling is crucial; therefore, any product with an opened carton or a broken or missing neckband should not be used.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen Oral Suspension Original Berry Flavor, 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 Childrens Ibuprofen Oral Suspension Original Berry Flavor, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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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.