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Kosher Meds Dye-Free Ibuprofen

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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 2025
Label revision date
October 29, 2025
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 2025
Label revision date
October 29, 2025
Manufacturer
Mollec Inc
Registration number
ANDA210602
NDC root
82179-006
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

You may be looking for a medication that helps relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, or toothache. This medication also works to reduce fever, providing temporary relief from discomfort associated with these conditions. It's designed to help you feel better when you're not feeling your best.

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, it's important to know that it doesn't 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. You’ll find a dosing chart included, which helps you determine the right dose based on your child's weight or age.

Use the enclosed dosing cup to measure the dose accurately; avoid using any other measuring devices. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times in a single day. After each use, securely replace the original bottle cap to keep it child-resistant and safe. If your child weighs less than 24 pounds or is under 2 years old, consult a doctor for the appropriate dosage. For children weighing between 24 to 95 pounds, the chart provides specific doses based on their weight and age.

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. Symptoms of such reactions may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rashes, 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 life-threatening, particularly if used in higher doses or for extended periods. If your child experiences severe or persistent sore throat, high fever, or any signs of stomach bleeding (such as faintness, vomiting blood, or black stools), or symptoms of heart problems (like chest pain or trouble breathing), seek medical attention immediately. Always consult a doctor before use if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

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

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

If you or your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor promptly. For any overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Always consult your doctor if symptoms worsen or new symptoms appear.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to minimize the risk of an overdose. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider.

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

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

When considering medication for your child, it's important to follow specific guidelines to ensure their safety. For children under 3 years old, do not use this medication for more than 2 days unless directed by a doctor. Dosing varies by weight and age, so consult the chart below for the appropriate amount:

  • Under 24 lbs (under 2 years): Ask 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

Before giving this medication, ask your doctor if your child has any of the following: a history of stomach issues, dehydration from vomiting or diarrhea, high blood pressure, heart disease, liver or kidney problems, asthma, or if they are taking other medications. Always consult a doctor if your child is under care for a serious condition.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 at a temperature between 20-25 °C (68-77 °F). This helps maintain its quality. It's also 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, as this could indicate that the product is compromised.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use. Always keep it in a secure place to avoid any damage or contamination.

Additional Information

No further information is available.

FAQ

What does this drug relieve?

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

How should I dose this medication?

Find the right dose on the dosing chart based on your child's weight or age. Use only the enclosed dosing cup and do not exceed the recommended dose.

What should I do if my child has a severe sore throat?

If your child has a severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting, consult a doctor promptly.

What are the signs of stomach bleeding I should watch for?

Watch for signs such as feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not improve.

Can this drug cause allergic reactions?

Yes, this drug may cause severe allergic reactions, especially in those allergic to aspirin. Symptoms can include hives, facial swelling, and difficulty breathing.

What should I do if my child experiences an allergic reaction?

If an allergic reaction occurs, stop use immediately and seek medical help right away.

Is there a risk of heart problems with this medication?

Yes, NSAIDs, including this drug, can increase the risk of heart attack, heart failure, and stroke, especially if used more than directed.

What precautions should I take before using this drug?

Ask a doctor before use if your child has a history of stomach problems, is dehydrated, or has conditions like high blood pressure or asthma.

How should I store this medication?

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

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

Packaging Info

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

Packaging configurations for Kosher Meds Dye-Free Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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 dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides specific guidance:

  • For patients weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Healthcare professionals should ensure that the original bottle cap is replaced after use to maintain child resistance. It is critical not to exceed the recommended dosage.

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

NSAIDs, with the exception of aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment beyond the recommended duration.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if symptoms persist beyond two days or if the patient is under three years of age unless otherwise directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice if the child exhibits any of the following signs of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is necessary. Caregivers should also be advised to report any new symptoms that arise during treatment.

Side Effects

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

Severe allergic reactions may occur, 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.

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

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used inappropriately, such as exceeding the recommended dosage or duration of treatment.

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

In the event of specific symptoms, patients are advised to discontinue use and consult a healthcare professional. Signs of stomach bleeding include 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 relief is not achieved within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical advice should be sought.

Before using ibuprofen, it is essential to consult a healthcare provider if any of the following apply: a history of stomach problems, previous adverse reactions to pain relievers or fever reducers, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or if the patient is taking diuretics. Additionally, patients under a doctor's care for serious conditions or those taking other medications should seek guidance prior to use.

Drug Interactions

There are currently no documented drug interactions associated with 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 Kosher Meds Dye-Free Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Kosher Meds Dye-Free Ibuprofen.
Details

Pediatric Use

Pediatric patients should not use this medication for more than 2 days or be administered to children under 3 years of age unless directed by a healthcare professional.

Dosing recommendations for pediatric patients are as follows:

  • For children under 24 lbs (under 2 years), consult a doctor.

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

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

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

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

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

  • Dosages may be adjusted as directed by a healthcare professional.

Before administering this medication, it is important to consult a doctor if any of the following conditions apply to the child: a history of stomach problems (such as heartburn), issues with pain relievers or fever reducers, dehydration from vomiting or diarrhea, or if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Additionally, consultation is advised if the child is taking a diuretic or is under a doctor's care for any serious condition or is taking any other medications.

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 are there any special precautions outlined regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and follow established protocols for overdose management.

In all instances of suspected overdose, healthcare professionals should report the event to the appropriate regulatory authorities and document the incident thoroughly in the patient's medical record.

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 indicated that the use of ibuprofen may be associated with several adverse reactions. Reports have included gastrointestinal bleeding, hepatic reactions, renal reactions, and cardiovascular events. Additionally, skin reactions have been noted, including serious conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Other reported reactions include anaphylactic reactions, asthma exacerbation, hypertension, edema, and heart failure. The frequency of these adverse reactions remains unknown, as they have been reported voluntarily or through surveillance programs.

Patient Counseling

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

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

Providers should instruct patients to stop 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 stomach pain that does not improve. Furthermore, patients should be advised to discontinue use and seek medical attention if the child shows symptoms 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 counseled to stop use and contact a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists for more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, it is recommended that patients administer it with food or milk if stomach upset occurs. Healthcare providers should encourage patients to consult a doctor before use if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues such as heartburn.

Patients should be advised 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 consult a doctor before use 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, healthcare providers should recommend that patients consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for maintaining its integrity. It is crucial to store the product at a temperature range of 20-25 °C (68-77 °F) to ensure optimal stability and efficacy.

Healthcare professionals should be aware that the product must not be used if the carton is opened or if the printed bottle neckband is broken or missing, as this may compromise the product's safety and effectiveness. Proper handling and adherence to these storage conditions are vital for maintaining the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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

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

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.