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Parox

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This product has been discontinued

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 2024
Label revision date
May 27, 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 2024
Label revision date
May 27, 2024
Manufacturer
SJ INCORPORATION LTD
Registration number
M013
NDC root
83658-016
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

Acetaminophen is a medication commonly used to relieve pain and reduce fever in children. It comes in a cherry-flavored oral suspension, specifically designed for infants and children, with a concentration of 160 mg per 5 ml. This medication is effective for alleviating minor aches and pains associated with conditions such as the common cold, flu, headaches, sore throats, and toothaches.

By temporarily lowering fever and easing discomfort, acetaminophen can help your child feel more comfortable during illness. It is dye-free, making it a suitable option for those who may have sensitivities to certain color additives.

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 common cold, flu, 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

If your child weighs less than 24 pounds and is under 2 years old, it's important to consult a doctor before giving any medication. For children who weigh between 24 and 35 pounds (ages 2 to 3 years), the recommended dose is 5 mL. If your child weighs between 36 and 47 pounds (ages 4 to 5 years), you should give them 7.5 mL.

For children weighing 48 to 59 pounds (ages 6 to 8 years), the dose increases to 10 mL. If your child weighs between 60 and 71 pounds (ages 9 to 10 years), the appropriate dose is 12.5 mL. Finally, for children who weigh 72 to 95 pounds (11 years old), the recommended dose is 15 mL. Always ensure you measure the dosage accurately for your child's weight to ensure their safety and effectiveness of the medication.

What to Avoid

You should avoid using this medication if you or your child are allergic to acetaminophen or any of the inactive ingredients in the product. Additionally, do not take this medication alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with a doctor or pharmacist for guidance.

Side Effects

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, including symptoms like skin reddening, blisters, or rash. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it's important to consult a doctor.

You should not use this product if your child is allergic to acetaminophen or any of its inactive ingredients, or if they are taking any other medications that contain acetaminophen. Additionally, consult a doctor if your child has liver disease or is taking the blood thinner warfarin. If pain worsens or lasts more than 5 days, fever persists for more than 3 days, new symptoms appear, or if there is redness or swelling, stop use and seek medical advice, as these could indicate a serious condition.

Warnings and Precautions

It's important to be aware of some key warnings 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 your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

Before using this product, check with a doctor if your child has liver disease or is taking the blood thinner warfarin. Always follow the recommended dosage to avoid overdose. If pain worsens or lasts more than 5 days, or if fever persists for more than 3 days, stop using the product and call your doctor. Also, seek medical advice if new symptoms develop or if there is redness or swelling, as these could indicate a serious condition.

Overdose

It's important to follow the recommended dosage when using this product. Taking more than the advised amount can lead to an overdose, which may cause serious health issues. Signs of an overdose can include symptoms like extreme drowsiness, confusion, or difficulty breathing (respiratory depression).

If you suspect an overdose, seek immediate medical help. It's crucial to act quickly, as timely intervention can make a significant difference in your recovery. Always remember to keep medications out of reach and to consult with a healthcare professional if you have any questions about the proper use of this product.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with medications. Specifically, if you are unsure whether a drug contains acetaminophen, you should consult your doctor or pharmacist before using it. Additionally, if you have liver disease or if you are taking the blood-thinning medication warfarin, it's essential to speak with your healthcare provider before using any medication.

Currently, there is no specific information available regarding the safety of acetaminophen during pregnancy, including any necessary dosage adjustments or special precautions. Always prioritize open communication with your healthcare team to ensure the best care for you and your baby.

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 giving this medication to your child, it's important to follow the dosing guidelines carefully to avoid any risks. For children under 2 years old or weighing less than 24 pounds, you should consult a doctor before administering the medication. For children aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases based on their weight, reaching a maximum of 15 mL for those who are 11 years old and weigh between 72 to 95 pounds.

Be cautious not to exceed the recommended dose, as taking more than 5 doses in 24 hours can lead to severe liver damage. It's also crucial to avoid using this medication alongside any other products containing acetaminophen, unless advised by a healthcare professional. If your child has liver disease, is taking blood thinners like warfarin, or shows any signs of worsening pain or fever, you should consult a doctor immediately. Always stop use if new symptoms arise or if there is redness or swelling.

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.

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 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 in these situations.

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 medication. Mixing these can increase the risk of bleeding, so it's crucial to ensure safety.

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 contains acetaminophen, don't hesitate to ask a healthcare professional for guidance. Always prioritize open communication about all medications to help prevent any harmful interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25ºC (68-77ºF). This temperature range helps maintain the product's quality. Before using, check that the carton tape or bottle wrap marked with "PAROX" is intact. If it is broken or missing, do not use the product, as this could indicate that it has been compromised.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is ACETAMINOPHEN used for?

ACETAMINOPHEN is a pain reliever and fever reducer that temporarily reduces fever and relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What is the dosage for children using ACETAMINOPHEN?

The dosage varies by weight: for children weighing 24-35 lbs (2-3 years), it's 5 mL; for 36-47 lbs (4-5 years), it's 7.5 mL; for 48-59 lbs (6-8 years), it's 10 mL; for 60-71 lbs (9-10 years), it's 12.5 mL; and for 72-95 lbs (11 years), it's 15 mL. For those under 24 lbs, consult a doctor.

Are there any warnings associated with ACETAMINOPHEN?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours or with other drugs containing acetaminophen. Additionally, it may cause severe skin reactions.

What should I do if my child's symptoms worsen?

Stop use and consult a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms occur, or if redness or swelling is present.

Can I use ACETAMINOPHEN with other medications?

Do not use ACETAMINOPHEN with any other drug containing acetaminophen. If unsure, consult a doctor or pharmacist.

What should I do before giving ACETAMINOPHEN to my child?

Ask a doctor before use if your child has liver disease or is taking the blood-thinning drug warfarin.

How should ACETAMINOPHEN be stored?

Store ACETAMINOPHEN between 20-25ºC (68-77ºF) and do not use if the carton tape or bottle wrap is broken or missing.

Is there any information about using ACETAMINOPHEN during pregnancy or nursing?

The insert does not provide specific information regarding the use of ACETAMINOPHEN during pregnancy or nursing.

Packaging Info

Below are the non-prescription pack sizes of Parox (children pain and fever acetaminophen 160 mg per 5ml). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Parox.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Infant's Parxo for Children is an oral suspension containing acetaminophen at a concentration of 160 mg per 5 mL. This formulation serves as a pain reliever and fever reducer. The product is dye-free and is available in a 100 mL bottle with a cherry flavor. The National Drug Code (NDC) for this product is 83658-016-01.

Uses and Indications

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

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

Dosage and Administration

For patients weighing under 24 lbs (under 2 years), it is recommended to consult a physician prior to administration. For those weighing between 24 and 35 lbs (ages 2 to 3 years), the appropriate dosage is 5 mL. Patients weighing 36 to 47 lbs (ages 4 to 5 years) should receive a dosage of 7.5 mL. For individuals weighing 48 to 59 lbs (ages 6 to 8 years), the dosage increases to 10 mL. Patients weighing 60 to 71 lbs (ages 9 to 10 years) should be administered 12.5 mL, while those weighing 72 to 95 lbs (age 11 years) should receive a dosage of 15 mL.

The specific route and frequency of administration have not been provided; therefore, healthcare professionals should determine the appropriate method of administration based on clinical judgment and individual patient needs.

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.

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 severe skin reactions, which may manifest as skin reddening, blisters, or rash. Healthcare professionals should be vigilant for these symptoms and advise patients to discontinue use immediately if they occur.

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, it is imperative to consult a physician promptly.

General precautions should be observed prior to administration. Healthcare providers should inquire about any existing liver disease in the child. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

Patients should be instructed to adhere strictly to the recommended dosage to avoid overdose. If pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days, medical advice should be sought. New symptoms, as well as any signs of redness or swelling, warrant immediate consultation with a healthcare professional, as these may indicate a serious underlying condition.

Emergency medical assistance should be sought if any severe adverse reactions occur.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if used concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of such symptoms, it is advised to discontinue use and seek medical attention.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients uncertain about the presence of acetaminophen in other medications are encouraged to consult a doctor or pharmacist. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Patients with liver disease should seek medical advice before using this product. Furthermore, those taking the blood-thinning medication warfarin should consult a healthcare provider or pharmacist prior to use.

Patients are advised to discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

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 may be heightened. 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 Parox (children pain and fever acetaminophen 160 mg per 5ml). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Parox.
Details

Pediatric Use

Pediatric patients should not exceed the recommended dosage of this product, as overdose may lead to severe liver damage, particularly if more than 5 doses are taken within a 24-hour period. The following dosing chart is provided for guidance based on weight and age:

  • 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

This product contains acetaminophen; therefore, it should not be used in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. Healthcare professionals should be consulted if there is uncertainty regarding the presence of acetaminophen in other medications.

Caution is advised for pediatric patients with liver disease, and a healthcare provider should be consulted before use in such cases. Additionally, if the child is taking the blood-thinning medication warfarin, it is important to seek advice from a doctor or pharmacist prior to administration.

Parents and caregivers should monitor for worsening pain or fever lasting more than 5 days and 3 days, respectively, as well as any new symptoms or signs of redness or swelling. If any of these occur, they should stop use and consult a healthcare professional.

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

The safety of acetaminophen use during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Pregnant patients should be cautious and consult with their healthcare provider before using acetaminophen, particularly if they have underlying health conditions such as liver disease. Additionally, it is advisable for pregnant patients to seek medical advice if they are taking other medications, such as blood thinners like warfarin, to avoid potential interactions. Given the lack of detailed information on safety concerns, dosage modifications, or special precautions, healthcare professionals should weigh the benefits against potential risks when considering acetaminophen for pregnant patients.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk are not established. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

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

Overdosage

Exceeding the recommended dose of this product may lead to serious health consequences. Healthcare professionals are advised to closely monitor patients for any signs of overdosage, as symptoms can vary depending on the specific circumstances and individual patient factors.

In the event of suspected overdosage, immediate medical attention should be sought. It is crucial to assess the patient's condition and provide appropriate management based on the severity of symptoms presented. Recommended actions may include supportive care and symptomatic treatment, tailored to the patient's needs.

Healthcare providers should remain vigilant and educate patients about the importance of adhering to the recommended dosage to mitigate the risk of overdosage and its associated complications.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. These events have been documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether they are prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

Additionally, healthcare providers must emphasize that this medication should not be used if the patient’s child has a known allergy to acetaminophen or any of the inactive ingredients present in the product. It is important for patients to be aware of these precautions to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in packaging that includes specific labeling for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) to maintain its integrity and efficacy.

Healthcare professionals should ensure that the carton tape or bottle wrap imprinted with "PAROX" is intact before use. If the seal is broken or missing, the product should not be used, as this may compromise its safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Parox, 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 Parox, 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.