ADD CONDITION

items per page

Kosher Meds

Last content change checked dailysee data sync status

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 2021
Label revision date
October 29, 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 2021
Label revision date
October 29, 2025
Manufacturer
Mollec Inc
Registration number
ANDA210602
NDC root
82179-001

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 should find the right dose by referring to the dosing chart provided, which takes into account your child's weight or age.

Use the enclosed dosing cup to measure the dose accurately; do not use any other device. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to use it more than four times a day. After using the product, be sure to 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 dose. For children weighing between 24 to 95 pounds, the dosing chart provides specific amounts 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 it right before or after heart surgery, as this could pose serious health risks. Always consult with a healthcare professional if you have any concerns about your child's health or medication use.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication can lead to severe stomach bleeding, especially in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be fatal if used improperly.

If your child experiences symptoms such as faintness, vomiting blood, bloody or black stools, or persistent stomach pain, you should seek medical attention immediately. Other concerning signs include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. It's important to consult a doctor if your child does not find relief within 24 hours, if their fever or pain worsens after three days, or if any new symptoms arise. Always talk to a healthcare professional before using ibuprofen if your child has a history of stomach issues, is dehydrated, or has other serious health conditions.

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 symptoms of heart problems like chest pain or trouble breathing, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if new symptoms appear, consult a doctor. In case of an overdose, seek 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 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 the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any risks or contraindications associated with its use. There are also no dosage modifications recommended for pregnant individuals, and no special precautions are outlined in the insert.

However, since there is no specific guidance provided, it's always 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, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of ibuprofen on babies who are breastfed haven't been thoroughly studied, it's best to be cautious and seek professional advice to ensure the safety of both you and your child.

Pediatric Use

When considering this medication for your child, it's important to follow specific guidelines to ensure their safety. You should not use it for more than 2 days or give it to children under 3 years old unless a doctor has advised you to do so. Always adhere to the recommended dosage, as giving more than directed can be harmful.

For dosing, the amount your child should receive depends on their weight and age. Here’s a quick reference: if your child is under 24 pounds and under 2 years old, consult a doctor first. For children aged 2-3 years weighing 24-35 pounds, the dose is 5 mL; for 4-5 years and 36-47 pounds, it's 7.5 mL; for 6-8 years and 48-59 pounds, it's 10 mL; for 9-10 years and 60-71 pounds, it's 12.5 mL; and for an 11-year-old weighing 72-95 pounds, the dose is 15 mL. Always follow your doctor’s instructions if they provide a different dosage.

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 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 plan.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25 °C (68-77 °F). It's important to keep the carton unopened and to check that the printed bottle neckband is intact; do not use the product if either is broken or missing.

When you're finished using the product, remember to securely replace the original bottle cap to maintain child resistance, helping to keep it safe from accidental access by children. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. It's important to keep this medication out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 a serious allergic reaction?

Signs of a serious allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Seek medical help immediately if these occur.

What should I do if my child experiences stomach bleeding?

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor.

Can this drug be used before or after heart surgery?

No, do not use this drug if your child has ever had an allergic reaction to Ibuprofen or any other pain reliever/fever reducer, or right before or after heart surgery.

Is it safe to use this drug during pregnancy?

There is no specific information provided regarding the use of this drug during pregnancy, so consult a doctor before use.

What should nursing mothers know about this drug?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

How should I store this medication?

Store the medication between 20-25 °C (68-77 °F) and do not use if the carton is opened or the printed 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 right away at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Kosher Meds.
Details

Drug Information (PDF)

This file contains official product information for Kosher Meds, 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 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 dosage 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 dosages are as follows:

  • 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.

If necessary, doses may be repeated every 6-8 hours, but it is crucial not to exceed four doses in a 24-hour period. After use, the original bottle cap should be replaced to ensure child resistance. It is imperative to adhere strictly to the dosing recommendations and not exceed the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to Ibuprofen or any other pain reliever or fever reducer should not use this product, as it may trigger severe allergic responses. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with its use in this context.

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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (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. Consultation with a physician is advised if such symptoms occur. 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 healthcare provider.

It is crucial to discontinue use and consult a physician 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, if symptoms suggestive of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical attention should be sought immediately. 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, a healthcare provider should be consulted. Any new symptoms that develop should also prompt a medical evaluation.

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

Side Effects

Patients using ibuprofen should be aware of 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 a risk of severe stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin and naproxen). The risk of stomach bleeding increases with prolonged use or higher than recommended dosages. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, ibuprofen carries warnings regarding cardiovascular risks, including an increased likelihood of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with excessive or prolonged use of the medication.

Patients should also be cautious of severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly if these symptoms occur. It is advised not to use ibuprofen for more than two days in the case of sore throat or to administer it to children under three years of age without a doctor's direction.

If a child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Additional symptoms such as redness or swelling in the painful area, or the emergence of new symptoms, should also prompt a discussion with a healthcare provider.

Before using ibuprofen, it is important to consult a doctor if the child has a history of stomach problems, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Patients with asthma or those taking diuretics should also seek medical advice prior to use.

Finally, it is essential to inform healthcare providers of any other medications being taken, especially if the child is under care for a serious condition.

Drug Interactions

There are currently no documented drug interactions or interactions with laboratory tests associated with this medication. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time. Healthcare professionals should continue to assess individual patient circumstances and consider any potential interactions based on the patient's overall medication regimen.

Packaging & NDC

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

Packaging configurations for Kosher Meds.
Details

Pediatric Use

Pediatric patients under 3 years of age should not be administered this medication unless directed by a healthcare professional. It is important to adhere to the recommended dosing guidelines and not exceed the directed dosage.

For children aged 2 to 11 years, the following dosing chart is provided based on weight:

  • Under 24 lbs (under 2 years): Consult a doctor for appropriate dosing.

  • 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

Dosing may also be adjusted as directed by a healthcare professional. The medication should not be used for more than 2 days in pediatric patients.

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 information available regarding the use of ibuprofen during pregnancy. The prescribing information does not mention any contraindications or risks associated with ibuprofen use in this population. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not 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

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further treatment if required.

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 question.

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 noted, particularly in patients with a history of stomach ulcers or bleeding problems, as well as in those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when used at higher doses or for extended durations beyond the recommended guidelines.

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 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 leg swelling.

Patients should also be informed to discontinue use and consult 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 it be taken with food or milk to minimize the risk of stomach upset. Healthcare providers should encourage patients to consult a doctor before use if the stomach bleeding warning applies to their child, or if the child has a history of stomach problems such as heartburn.

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, it is important to consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or has had a stroke. Patients should also be advised to seek medical advice if the child has asthma, is taking a diuretic, or is under a doctor's care for any serious condition. Lastly, patients should be encouraged to consult a doctor or pharmacist before use 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. If the carton is opened or the neckband is broken or missing, the product should not be used.

Storage conditions require that the product be maintained at a temperature between 20-25 °C (68-77 °F). To ensure safety, the original bottle cap must be replaced after each use to maintain child resistance.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses in a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Kosher Meds, 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, 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

Last AI update:

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.