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Dye Free Childrens Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL – 200 mg/10 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
January 31, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL – 200 mg/10 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
January 31, 2025
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Registration number
ANDA210602
NDC roots
0121-1022, 0121-2044
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Dye Free Children's Ibuprofen is an oral suspension that belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is designed to help relieve minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. Additionally, it effectively reduces fever, making it a useful option for managing discomfort in children.

This medication is berry-flavored, dye-free, and alcohol-free, providing a palatable option for kids. Each 5 mL dose contains 100 mg of ibuprofen, ensuring that it delivers effective pain relief and fever reduction in a convenient liquid form.

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 birth defects. This makes it a safer choice for those who may be concerned about such risks.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before each use.

To find the right dose, refer to the dosing chart based on your child's weight or age. For example, if your child weighs between 24 and 35 pounds (approximately 2-3 years old), the dose is 5 milliliters (mL). If your child weighs between 36 and 47 pounds (around 4-5 years old), the dose increases to 7.5 mL. You can repeat the dose every 6 to 8 hours if necessary, but remember not to use it more than four times a day. If your child weighs less than 24 pounds or is under 2 years old, it's best to consult a doctor for 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 allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of 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 fatal, particularly if used in higher doses or for longer than recommended. If your child experiences severe or persistent sore throat, high fever, or symptoms of stomach bleeding (such as faintness, vomiting blood, or black stools), or shows signs of heart problems or stroke (like chest pain or weakness on one side of the body), seek medical attention immediately. Always consult a doctor if your child has any underlying health conditions or is taking other medications 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, asthma (wheezing), shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

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

For children, do not use ibuprofen for more than two days without consulting a doctor, especially if they have a severe sore throat with high fever, headache, nausea, or vomiting. If symptoms worsen or new symptoms appear, seek medical advice. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

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

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that there is no detailed information available about how the medication may affect you or your baby, including whether any dosage adjustments or special precautions are necessary.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

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 to 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

This product is safe for children, but there are important guidelines to follow. It should not be used in children under 3 years old unless a doctor advises it. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs between 24-35 pounds, they can take 5 mL, while those weighing 72-95 pounds can take 15 mL.

Before using this product, consult a doctor if your child has not been drinking fluids, has lost fluids from vomiting or diarrhea, or has a history of stomach issues, high blood pressure, heart disease, liver or kidney problems, or asthma. It's also important to seek medical advice if your child experiences no relief within 24 hours or if their fever or pain worsens or lasts more than three days. Always prioritize your child's health and safety by discussing any concerns with a healthcare professional.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your treatment plan. Always prioritize open communication with your doctor regarding your health conditions.

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 may also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have.

Drug Interactions

It's important to be aware of potential interactions when your child is taking ibuprofen. If your child is allergic to aspirin, they may experience severe allergic reactions to ibuprofen. Additionally, the risk of stomach bleeding increases if they are also taking blood thinners (medications that prevent blood clots) or steroids, as well as other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

Before giving ibuprofen, make sure to consult with your healthcare provider, especially if your child is on a diuretic (a medication that helps remove excess fluid from the body) or any other medications. This will help ensure their safety and avoid any serious complications.

Storage and Handling

To ensure the best use of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Before using, make sure to shake the product well to mix its contents thoroughly. It's important to keep the product out of reach of children for safety. Once opened, please remember to discard it to maintain safety and effectiveness.

Additional Information

This product does not provide specific directions or warnings for adult use. If you experience stomach upset, it's recommended to take it with food or milk. You can repeat the dose every 6 to 8 hours if necessary, but do not exceed four doses in a day.

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

FAQ

What is Dye Free Children's Ibuprofen?

Dye Free Children's Ibuprofen is an oral suspension (liquid form) that acts as a pain reliever and fever reducer, specifically formulated for children.

What conditions does this medication relieve?

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

How should I administer this medication?

You should shake well before using and follow the dosing chart based on your child's weight and age. If needed, you can repeat the dose every 6–8 hours, but do not exceed 4 doses in a day.

What are the dosing recommendations for children?

For children weighing under 24 lbs, consult a doctor. For those weighing 24-35 lbs (2-3 years), the dose is 5 mL; 36-47 lbs (4-5 years) is 7.5 mL; 48-59 lbs (6-8 years) is 10 mL; 60-71 lbs (9-10 years) is 12.5 mL; and 72-95 lbs (11 years) is 15 mL.

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.

What should I do if my child experiences side effects?

Stop use and seek medical help if your child shows signs of an allergic reaction, stomach bleeding, or symptoms of heart problems or stroke.

Is this medication safe for children under 3 years?

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

How should I store Dye Free Children's Ibuprofen?

Store it between 20° to 25°C (68° to 77°F) and keep it out of reach of children. Discard after opening.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Dye Free Childrens Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is a dye-free children's ibuprofen oral suspension, classified as a nonsteroidal anti-inflammatory drug (NSAID). Each 5 mL dose contains 100 mg of ibuprofen, serving as a pain reliever and fever reducer. The formulation is berry flavored, alcohol-free, and designed for ease of use, requiring shaking before administration. The product is packaged in a non-child-resistant container. It is manufactured by PAI Pharma, located in Greenville, SC, with the National Drug Code (NDC) 0121-1022-05.

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 to ensure proper mixing.

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

If necessary, doses may be repeated every 6 to 8 hours; however, 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 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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of such an event 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 (including aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment may further elevate this risk.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to 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 prolonged periods.

In cases of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, immediate medical consultation is advised. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a physician.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, 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, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

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

Side Effects

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

Severe allergic reactions can occur, 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 carries a warning for potential severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroids, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of use. Signs of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Additionally, there is a significant risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk increases with higher doses or prolonged use. Patients should be vigilant for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients should also be aware of the warning regarding severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly. Ibuprofen should not be used for more than two days or in children under three years of age without a doctor's direction.

It is advised to discontinue use and consult a healthcare professional if any of the aforementioned symptoms arise or if the patient does not achieve relief within the first 24 hours of treatment. Additionally, if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical attention should be sought.

Patients with a history of allergic reactions to ibuprofen or other pain relievers/fever reducers should avoid this medication. It is contraindicated for use immediately before or after heart surgery. Prior to use, patients should consult a healthcare provider if they have a history of stomach issues, are experiencing dehydration, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Caution is also advised for those taking diuretics or under medical care for serious conditions.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

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

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

Diuretics Patients taking diuretics should consult a healthcare provider prior to using ibuprofen, as potential interactions may necessitate dosage adjustments or increased monitoring.

General Recommendations It is prudent to seek medical advice before administering ibuprofen to children who are on any other medications, as interactions may occur that could affect therapeutic outcomes or safety.

Packaging & NDC

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

Packaging configurations for Dye Free Childrens Ibuprofen.
Details

Pediatric Use

This product is intended for use in children. It is not recommended for children under 3 years of age unless directed by a doctor.

Dosing Information:

  • For children under 24 lbs (under 2 years): Consult a doctor.

  • For children weighing 24-35 lbs (2-3 years): Administer 5 mL.

  • For children weighing 36-47 lbs (4-5 years): Administer 7.5 mL.

  • For children weighing 48-59 lbs (6-8 years): Administer 10 mL.

  • For children weighing 60-71 lbs (9-10 years): Administer 12.5 mL.

  • For children weighing 72-95 lbs (11 years): Administer 15 mL.

Cautions: Consult a doctor if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea. Additionally, a doctor should be consulted if the child has a history of stomach problems (e.g., heartburn), has experienced serious side effects from pain relievers or fever reducers, or has any of the following conditions: high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Special caution is advised for children with asthma or those taking a diuretic.

Parents or caregivers should stop use and consult a doctor 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 3 days.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific mention of pregnancy use, safety concerns, dosage modifications, or special precautions regarding the use of this medication during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled regarding the absence of established safety information in pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of therapy in individuals with reduced kidney function. Monitoring and appropriate dosing adjustments may be necessary 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. Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition.

Healthcare providers should consider the overall clinical status of patients with hepatic impairment, including any concurrent conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these may further influence treatment decisions and monitoring requirements.

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 support 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, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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

Patients should be informed to take the medication with food or milk if they experience stomach upset. It is important for healthcare providers to encourage patients to consult a doctor before use if any of the following conditions apply to their child: a warning for stomach bleeding, a history of stomach problems such as heartburn, previous serious side effects from pain relievers or fever reducers, insufficient fluid intake, significant fluid loss due to 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.

Additionally, patients should be advised to consult a doctor or pharmacist before use if the child is under a doctor’s care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy. Prior to use, the product must be shaken well to ensure proper mixing of its components.

To ensure safety, the product should be kept out of reach of children. Additionally, it is important to discard the product after opening to prevent any potential contamination or degradation.

Additional Clinical Information

This product does not provide complete directions or warnings for adult use. Patients are advised to take the medication with food or milk if they experience stomach upset. Dosing may be repeated every 6–8 hours as needed, but should not exceed four doses in a 24-hour period.

Clinicians should counsel patients to keep the product 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.

Drug Information (PDF)

This file contains official product information for Dye Free Childrens 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 Dye Free Childrens Ibuprofen, retrieved by a validated AI data-extraction workflow.

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

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

No human clinician has reviewed this version.

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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.