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Kosher Meds Childrens Pain and Fever

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Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
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
May 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
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
May 15, 2024
Manufacturer
Mollec Inc
Registration number
M013
NDC root
82179-002
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

This drug is designed to help you feel better when you're experiencing discomfort from minor aches and pains, such as those caused by the common cold, flu, headache, sore throat, or toothache. Additionally, it can temporarily reduce fever, providing relief when you're feeling unwell.

Uses

You can use this medication to temporarily reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold and flu, as well as headaches, sore throats, and toothaches.

This means that if you're feeling under the weather or experiencing mild pain, this medication can help make you feel more comfortable. Always remember to follow the recommended guidelines for use.

Dosage and Administration

Before using this product, make sure to shake it well. To find the right dose for you or your child, refer to the dosing chart based on weight or age. If you’re unsure, especially for children under 2 years old, it’s best to ask a doctor for guidance.

Once you have the correct dose, you can repeat it every 4 hours as needed while symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Additionally, do not use this product for more than 5 days unless your doctor advises otherwise. Always use the enclosed dosing cup that comes with the product, as other devices may not provide accurate measurements.

What to Avoid

You should avoid using this medication if you are taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication includes acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if your child is allergic to acetaminophen or any of its inactive ingredients.

It's also important to follow the recommended dosage carefully and not exceed it, as doing so can lead to serious health risks. Always be mindful of these guidelines to ensure safe use of the medication.

Side Effects

You should be aware that this product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

It's important to consult a doctor if your child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. You should also stop use and contact a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling. Always check with a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

Warnings and Precautions

It's important to be aware of some key warnings and precautions when using this product, which contains acetaminophen. Taking more than 5 doses in 24 hours can lead to severe liver damage, especially if combined with other medications that also contain acetaminophen. Additionally, be cautious of potential severe skin reactions, such as reddening, blisters, or rash. If you notice any skin reactions, stop using the product and seek medical help immediately. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Before using this product, check with a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. If you suspect an overdose, which can also cause liver damage, seek medical help or contact a Poison Control Center right away at 1-800-222-1222. It's crucial to get quick medical attention for both adults and children, even if there are no immediate signs of overdose.

You should also stop using the product and call your doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms develop, or if there is any redness or swelling, as these could indicate a serious condition.

Overdose

If your child takes more than 5 doses of this medication in a 24-hour period, it can lead to severe liver damage. It's important to be aware that combining this product with other medications that contain acetaminophen (a common pain reliever) can also increase the risk of serious liver harm.

If you suspect an overdose, look for signs such as unusual tiredness, nausea, vomiting, or abdominal pain. If you notice any of these symptoms or if you believe your child has taken too much of the medication, seek immediate medical help. Always prioritize safety and consult a healthcare professional if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious about the medications you take. Currently, there is no specific information available regarding the use of acetaminophen during pregnancy, which means there are no established safety concerns, dosage changes, or special precautions outlined for its use.

Before taking any medication, including acetaminophen, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your individual situation. Your health and the health of your baby are paramount, so always seek professional advice when considering medication during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When giving medication to your child, it's important to follow specific dosing guidelines based on their weight and age. For children under 2 years old who weigh less than 24 lbs, you should consult a doctor before administering any medication. For children aged 2-3 years weighing between 24-35 lbs, the recommended dose is 5 mL (1 teaspoon). As your child grows, the dosage increases: 7.5 mL (1 ½ teaspoons) for ages 4-5 years (36-47 lbs), 10 mL (2 teaspoons) for ages 6-8 years (48-59 lbs), 12.5 mL (2 ½ teaspoons) for ages 9-10 years (60-71 lbs), and 15 mL (3 teaspoons) for 11-year-olds (72-95 lbs).

It's crucial not to exceed 5 doses in a 24-hour period, as this is the maximum safe amount for children. If your child has liver disease or is taking the blood-thinning medication warfarin, consult a doctor or pharmacist before use. Be aware that taking more than the recommended dose can lead to serious liver damage, so seek immediate medical help if an overdose is suspected, even if your child shows no symptoms.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

Hepatic Impairment

If you or your child have liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, be aware that combining this product with other medications that also contain acetaminophen can increase the risk of liver damage.

To ensure safety, always check the labels of any other medications you may be using and consult with your healthcare provider if you have any concerns about liver function or dosage adjustments. Monitoring your liver health is crucial, so keep your doctor informed about any changes in your condition.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, so ensuring that your healthcare provider is aware of all medications your child is taking is crucial for their safety. Always prioritize open communication about any treatments or tests to avoid potential interactions.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically between 20-25°C (68-77°F). It's important not to refrigerate the product, as this can affect its effectiveness.

Make sure to keep the original carton, as it contains important directions for use that you will need. Following these storage guidelines will help maintain the product's quality and safety.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 4 hours while symptoms persist. However, do not exceed 5 doses in a 24-hour period, and avoid using it for more than 5 days unless your doctor advises otherwise.

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. Quick medical attention is crucial for both adults and children, even if there are no noticeable signs or symptoms.

FAQ

What does this drug do?

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

How should I dose this medication?

You should find the right dose on the dosing chart based on your child's weight or age. If needed, you can repeat the dose every 4 hours while symptoms last, but do not exceed 5 doses in 24 hours.

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

If your child's sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Are there any warnings I should be aware of?

Yes, this product contains acetaminophen, which can cause severe liver damage if more than 5 doses are taken in 24 hours or if used with other acetaminophen-containing drugs. Additionally, it may cause severe skin reactions.

Can I use this drug if my child has liver disease?

You should ask a doctor before using this medication if your child has liver disease.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for both children and adults.

Is this drug safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of this drug during pregnancy or nursing, so consult your doctor for advice.

How should I store this medication?

Store the medication between 20-25°C (68-77°F) and do not refrigerate. Keep the carton for full directions for use.

Packaging Info

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

Packaging configurations for Kosher Meds Childrens Pain and Fever.
Details

Drug Information (PDF)

This file contains official product information for Kosher Meds Childrens Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

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. Prior to administration, the product must be shaken well to ensure proper mixing.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician for the appropriate dosage. For patients weighing between 24 and 35 pounds (ages 2-3 years), the recommended dose is 5 mL (1 teaspoonful). For those weighing 36 to 47 pounds (ages 4-5 years), the dose is 7.5 mL (1.5 teaspoonfuls). Patients weighing 48 to 59 pounds (ages 6-8 years) should receive 10 mL (2 teaspoonfuls), while those weighing 60 to 71 pounds (ages 9-10 years) should be given 12.5 mL (2.5 teaspoonfuls). For patients weighing 72 to 95 pounds (age 11 years), the recommended dose is 15 mL (3 teaspoonfuls).

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is crucial not to exceed 5 doses within a 24-hour period. Additionally, this product should not be administered for more than 5 consecutive days unless directed by a physician.

Healthcare professionals must utilize only the enclosed dosing cup specifically designed for this product; the use of any other dosing device is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • In patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

  • Exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the child exceeds five doses within a 24-hour period or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to the recommended dosing guidelines to mitigate the risk of liver injury.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should be vigilant regarding the potential for overdose, which can lead to significant liver damage. Caregivers must be instructed to seek immediate medical help or contact a Poison Control Center (1-800-222-1222) if an overdose is suspected, even in the absence of symptoms. Quick medical intervention is crucial for both adults and children.

Before administering this product, it is advisable to consult a physician if the child has a history of liver disease. Additionally, caregivers should seek guidance from a healthcare provider or pharmacist if the child is concurrently taking warfarin or other anticoagulants, as interactions may occur.

Caregivers should be instructed to discontinue use and contact a healthcare professional if the child's pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition requiring further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Additionally, a warning is issued for patients experiencing a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting; such symptoms warrant prompt consultation with a healthcare provider.

Common adverse reactions necessitating medical consultation include worsening pain that lasts beyond five days, fever that persists for more than three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Patients with a history of liver disease should consult a healthcare professional prior to use. Furthermore, it is advisable for patients taking the anticoagulant warfarin to seek guidance from a doctor or pharmacist before using this product.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Packaging configurations for Kosher Meds Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lbs should consult a doctor before use. For children aged 2 to 3 years weighing between 24-35 lbs, the recommended dose is 5 mL (1 tsp). For those aged 4 to 5 years and weighing 36-47 lbs, the dose increases to 7.5 mL (1 1⁄2 tsp). Children aged 6 to 8 years, weighing 48-59 lbs, should receive 10 mL (2 tsp), while those aged 9 to 10 years and weighing 60-71 lbs should be given 12.5 mL (2 1⁄2 tsp). Finally, for children aged 11 years weighing 72-95 lbs, the appropriate dose is 15 mL (3 tsp).

It is important to note that pediatric patients should not exceed 5 doses in a 24-hour period, which is the maximum daily amount for children. Parents or caregivers should consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin prior to use.

An overdose may lead to liver damage; therefore, immediate medical attention is essential for children who may have ingested more than the recommended dose, even if no signs or symptoms are present.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are thoroughly evaluated.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the recommended dosage guidelines to prevent severe liver damage. Specifically, patients must not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver injury. Regular assessment of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in monitoring patients who may have ingested doses beyond this threshold.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk for liver injury. It is essential to assess the patient's medication history to identify any potential interactions that could exacerbate the risk of hepatotoxicity.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management protocols, which may include supportive care and monitoring of liver function tests. Early intervention is crucial to mitigate the risk of long-term hepatic complications.

Prompt recognition and management of acetaminophen overdosage can significantly improve patient outcomes.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage of this medication, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to ensure that the medication is not administered to children who are allergic to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dose, and they should be reminded of the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a carton that contains essential information for proper use. It is important to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as the product should not be exposed to lower temperatures. Users are advised to retain the carton to access the full directions for use.

Additional Clinical Information

Patients should be informed that the medication is administered orally and may be repeated every 4 hours as needed while symptoms persist. However, it should not be given more than 5 times within a 24-hour period and should not be used for more than 5 consecutive days unless directed by a healthcare provider.

Clinicians should counsel patients to keep the medication 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, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Kosher Meds Childrens Pain and Fever, 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 Childrens Pain and Fever, 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.