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Kids Pain and Fever

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Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Liquid
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
May 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Liquid
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
May 23, 2025
Manufacturer
Genexa Inc.
Registration number
M013
NDC root
69676-0084
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

Genexa Kids' Pain & Fever is a clean medicine designed for children ages 2 to 11. It contains acetaminophen (a common pain reliever and fever reducer) at a dosage of 160 mg per 5 mL in an oral suspension. This product is formulated to temporarily reduce fever and relieve minor aches and pains associated with conditions like the common cold, headache, toothache, flu, and sore throat.

What sets Genexa apart is its commitment to being free from artificial additives, preservatives, flavors, and dyes, making it a safer choice for your child. It comes in a pleasant cherry flavor and is available in a 4 fl oz (118 mL) bottle.

Uses

You can use this medication to temporarily reduce fever and relieve minor aches and pains associated with various conditions. It is effective for symptoms related to the common cold, headaches, toothaches, the flu, and sore throats.

This means that if you're feeling under the weather with any of these issues, this medication can help make you feel more comfortable. Always remember to follow the recommended guidelines for use.

Dosage and Administration

Before you use the medication, make sure to shake the bottle well. To find the right dose for you or your child, refer to the dosage chart based on weight or age. For accurate dosing, always use the measuring cup that comes with the medication, and avoid using any other dosing devices to ensure safety.

You should give the dose every 4 hours as long as symptoms persist, but remember not to exceed 5 doses in a 24-hour period. If possible, use your child's weight to determine the dose; if you don't have that information, you can use their age instead. Here’s a quick reference for dosing: if your child weighs under 24 lbs or is under 2 years old, consult a doctor. For children weighing between 24-35 lbs (ages 2-3), the dose is 5 mL; for 36-47 lbs (ages 4-5), it’s 7.5 mL; for 48-59 lbs (ages 6-8), it’s 10 mL; for 60-71 lbs (ages 9-10), it’s 12.5 mL; and for those weighing 72-95 lbs (age 11), the dose is 15 mL.

What to Avoid

It's important to be cautious when using this medication. You should not take it alongside any other drug that contains acetaminophen, whether it's a prescription or over-the-counter medication. If you're unsure whether a drug includes acetaminophen, please consult your doctor or pharmacist for guidance.

By following this advice, you can help ensure your safety and avoid potential complications. Always prioritize open communication with your healthcare provider about any medications you are taking.

Side Effects

You should be aware of some important warnings and potential side effects associated with this product. It 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 any of these symptoms occur, stop using the product and seek medical help immediately.

It's also important to monitor for severe sore throat symptoms that last more than 2 days or are accompanied by fever, headache, rash, nausea, or vomiting; consult a doctor in these cases. You should stop using the product 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, as these could indicate a serious condition. In case of overdose, seek medical assistance or contact a Poison Control Center right away, even if no symptoms are present.

Warnings and Precautions

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. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any skin reactions, stop using the product and seek medical help immediately. Additionally, 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 right away.

Before using this product, it's important to ask a doctor if your child has liver disease or is taking the blood-thinning medication warfarin. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222, even if there are no immediate signs or symptoms. You should also stop using the product and call your doctor if your child's pain worsens or lasts more than 5 days, if a fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling, as these could indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Even if you don’t see any signs or symptoms, getting prompt medical attention is crucial.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Always err on the side of caution—if you think an overdose has occurred, don’t wait for symptoms to appear before seeking help. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of acetaminophen during pregnancy has not been fully established. Before using this medication, you should consult your doctor to discuss any potential risks to your fetus, as these have not been completely evaluated. Acetaminophen should only be used if it is clearly needed and if the benefits outweigh any possible risks.

There are no specific dosage adjustments recommended for pregnant individuals, so it's best to seek guidance from your healthcare professional regarding the appropriate use. Additionally, be vigilant for any adverse effects while taking acetaminophen and report any concerns to your healthcare provider promptly. Your health and the health of your baby are the top priority.

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 be passed into your breast milk, which means it could affect your nursing infant. Since the effects of acetaminophen on babies who are breastfed haven't been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

When giving medication to your child, it's important to follow the dosing guidelines carefully. Always use the measuring cup provided to ensure accurate dosing, and avoid using any other devices. You should administer the dose every 4 hours as needed, but do not exceed 5 doses in a 24-hour period. If possible, base the dose on your child's weight; if you don't have that information, you can use their age instead.

Here’s a quick reference for dosing based on weight and age: for children under 24 lbs. and under 2 years, consult a doctor first. For those weighing 24-35 lbs. (ages 2-3), give 5 mL; for 36-47 lbs. (ages 4-5), give 7.5 mL; for 48-59 lbs. (ages 6-8), give 10 mL; for 60-71 lbs. (ages 9-10), give 12.5 mL; and for 72-95 lbs. (age 11), give 15 mL. Always check with a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

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 for personalized advice. 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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If your child has liver disease, it’s important to consult with a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional guidance.

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. Mixing these medications can lead to serious complications, so always check first.

Additionally, avoid using this medication alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication has acetaminophen, don't hesitate to ask a healthcare professional for guidance. Keeping open communication with your healthcare provider helps ensure safe and effective treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is Genexa Kids' Pain & Fever?

Genexa Kids' Pain & Fever is a clean medicine for children ages 2-11, containing acetaminophen 160 mg per 5 mL in a cherry-flavored oral suspension.

What does Genexa Kids' Pain & Fever do?

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

How should I dose Genexa Kids' Pain & Fever?

Use the measuring cup provided for accurate dosing. Give the dose every 4 hours while symptoms last, and do not exceed 5 doses in 24 hours.

What is the dosage for children based on weight?

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

Are there any warnings associated with Genexa Kids' Pain & Fever?

Yes, it 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.

What should I do if my child experiences a skin reaction?

If your child develops skin reddening, blisters, or a rash, stop use immediately and seek medical help.

Is Genexa Kids' Pain & Fever safe during pregnancy?

The safety of acetaminophen during pregnancy has not been established. Consult a doctor before use if pregnant or planning to become pregnant.

Can nursing mothers use Genexa Kids' Pain & Fever?

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

What should I do in case of an overdose?

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

How should I store Genexa Kids' Pain & Fever?

Store the product between 20-25°C (68-77°F).

Packaging Info

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

Packaging configurations for Kids Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Genexa® is a clean medicine formulation designed for the management of pain and fever in children aged 2 to 11 years. Each 5 mL dose of the oral suspension contains 160 mg of acetaminophen, serving as a pain reliever and fever reducer. This product shares the same active ingredient as Children’s Tylenol®*. The formulation is free from artificial additives, ensuring a composition devoid of common allergens, artificial preservatives, flavors, and dyes. The product is presented in a 4 fl oz (118 mL) bottle and features a cherry flavor for palatability.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should instruct patients or caregivers to shake the medication well before each use. For accurate dosing, the measuring cup provided with the medication should be utilized, and it is important to avoid using any other dosing device.

Dosing should be determined primarily by the patient's weight; however, if weight is not available, age may be used as a secondary guide. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides specific dosing recommendations based on weight and age:

  • For patients weighing under 24 lbs. or under 2 years of age, it is advised to consult a doctor for appropriate dosing.

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

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

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

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

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

Adherence to these guidelines will ensure safe and effective administration of the medication.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This precaution is necessary to avoid the risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen has been associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the presence of liver disease before recommending this product for use in children. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent. The Poison Control Center can be reached at 1-800-222-1222.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen.

Additionally, there is an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use immediately and seek medical assistance.

Patients are advised to consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

It is also recommended that patients stop use and consult a healthcare professional if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if no signs or symptoms are present, as prompt medical attention is essential.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Packaging configurations for Kids Pain and Fever.
Details

Pediatric Use

Pediatric patients should not exceed the recommended dosage as outlined in the Overdose warning. For accurate dosing, the measuring cup provided should be utilized, and no other dosing device should be employed. Dosing should occur every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

When determining the appropriate dose, weight should be used if possible; otherwise, age may be considered. The following dosing guidelines apply:

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

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

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

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

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

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

Healthcare professionals should advise parents or guardians to consult a doctor before use if the child has liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the child is concurrently taking the blood-thinning medication warfarin.

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, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. Potential risks to the fetus have not been fully evaluated; therefore, acetaminophen should only be used if clearly needed and if the benefits outweigh the risks.

No specific dosage modifications for pregnant individuals are provided; healthcare professionals should be consulted for guidance on appropriate dosing. It is also important to monitor for any adverse effects during pregnancy and report any concerns to a healthcare provider.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of the impairment. Careful evaluation is necessary to ensure the safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients 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 a doctor or pharmacist for clarification.

Patients should be instructed to stop using the medication and seek medical advice if they experience any of the following: worsening pain that lasts more than 5 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious condition that requires further evaluation.

Additionally, healthcare providers should recommend that patients consult a doctor before using this medication if their child has liver disease. It is also essential to advise patients to speak with a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin, as there may be potential interactions that need to be managed.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Kids 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 Kids 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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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.