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Adwe Childrens Pain 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)
Marketed in the U.S.
Since 2022
Label revision date
July 17, 2025
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
Marketed in the U.S.
Since 2022
Label revision date
July 17, 2025
Manufacturer
RARITAN PHARMACEUTICALS INC
Registration number
M013
NDC root
68163-695

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Drug Overview

Acetaminophen is an oral suspension medication designed for children aged 2 to 11 years. It is commonly used to reduce fever and relieve minor aches and pains associated with conditions like the common cold, flu, headaches, sore throats, and toothaches. This product is dye-free, sugar-free, and contains a naturally flavored cherry taste, making it more appealing for children.

With a dosage of 160 mg per 5 mL, acetaminophen provides effective relief while being gentle on young bodies. It is important to follow the recommended guidelines for use to ensure safety and effectiveness.

Uses

You can use this medication to temporarily reduce fever and relieve minor aches and pains. It is effective for discomfort caused by various conditions, including 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

Before using this product, make sure to shake it well. You’ll need to measure the correct dose based on your child's weight or age. For children under 2 years old who weigh less than 24 pounds, it’s best to consult a doctor for the appropriate dose. If your child is between 24 and 35 pounds (ages 2-3 years), give them 5 mL. For those weighing 36 to 47 pounds (ages 4-5 years), the dose is 7.5 mL. If your child weighs between 48 and 59 pounds (ages 6-8 years), the dose increases to 10 mL. For children weighing 60 to 71 pounds (ages 9-10 years), the dose is 12.5 mL, and for those who weigh 72 to 95 pounds (age 11 years), the dose is 15 mL.

When administering the medication, remove the child protective cap and squeeze the measured dose into the enclosed dosing cup, which is specifically designed for this product. You can repeat the dose every 4 hours as long as symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Always follow these guidelines closely to ensure your child's safety and well-being.

What to Avoid

It's important to be cautious when using this medication. You should not use it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains 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.

Always follow the recommended dosage and avoid exceeding it, as doing so can lead to serious health risks. If you have any questions or concerns about using this medication, don't hesitate to reach out to a healthcare professional for guidance.

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, including redness, blisters, or rashes. If you notice any of these symptoms, 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 right away. It's also important to avoid using this product with any other acetaminophen-containing medications and to seek advice from a healthcare professional if your child has liver disease or is taking blood thinners like warfarin. Always monitor for worsening pain or fever, new symptoms, or any signs of redness or swelling, and seek medical attention if these occur. In case of overdose, contact a medical professional or Poison Control Center immediately, as prompt action is crucial.

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 of these symptoms, 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. Always follow the recommended dosage to avoid overdose. If you suspect an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222, as quick attention is crucial for both adults and children.

You should stop using the product and call your doctor if your child's pain worsens or lasts more than 5 days, if their fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling. These could indicate a more serious condition that needs medical attention.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick medical attention is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but it’s always better to be safe and get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it could be passed into your breast milk, and the effects on your nursing infant haven't been thoroughly studied. Therefore, it's wise to be cautious.

Acetaminophen is usually regarded as safe for breastfeeding mothers, but you should keep an eye on your baby for any unusual reactions. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

When giving this medication to your child, it's important to follow specific guidelines based on their weight and age. For children under 24 pounds (under 2 years), you should ask a doctor before administering. If your child weighs between 24-35 pounds (ages 2-3), the recommended dose is 5 mL. For those weighing 36-47 pounds (ages 4-5), the dose increases to 7.5 mL, and for children weighing 48-59 pounds (ages 6-8), the dose is 10 mL. As your child grows, the dosage continues to increase: 12.5 mL for those weighing 60-71 pounds (ages 9-10) and 15 mL for children weighing 72-95 pounds (11 years).

It's crucial not to exceed 5 doses in a 24-hour period, as taking more can lead to severe liver damage. Always use the dosing cup provided with the medication, and never use other devices. Be aware of potential severe skin reactions and seek medical help if any occur. If your child has a severe sore throat that lasts more than two days or is accompanied by other symptoms like fever or rash, consult a doctor. Additionally, consult a doctor if your child has liver disease or is taking the blood-thinning medication warfarin.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is primarily indicated for children aged 2 to 11 years. This means that if you are caring for an older adult, there are no special dosage adjustments or safety concerns noted for them. However, it's always a good idea to consult with a healthcare professional before starting any new medication, especially for older individuals who may have unique health considerations.

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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If your child has liver disease, it’s important to consult a doctor before using this product. This medication contains acetaminophen, which can be harmful to the liver. Be aware that taking more than 5 doses in a 24-hour period—this is the maximum daily amount—or using it alongside other medications that also contain acetaminophen can lead to severe liver damage. Always follow your healthcare provider's guidance to ensure your child's safety.

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, you should 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 room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or specific handling procedures, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as your symptoms persist. However, make sure not to exceed 5 doses within a 24-hour period to avoid potential complications. If you have any questions or concerns about your treatment, it's always a good idea to consult with your healthcare provider.

FAQ

What is Acetaminophen used for?

Acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children weighing 24-35 lbs (2-3 years) should take 5 mL, while those weighing 72-95 lbs (11 years) should take 15 mL.

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 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.

Can I use Acetaminophen if my child is allergic to it?

No, do not use Acetaminophen if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

What should I do in case of an overdose?

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

Is Acetaminophen safe to use during breastfeeding?

Acetaminophen is generally considered safe during breastfeeding, but nursing mothers should consult a doctor before use and monitor the infant for any adverse effects.

How should I administer Acetaminophen to my child?

Use only the enclosed dosing cup specifically designed for this product. Do not use any other dosing device, and shake well before using.

What should I do if my child's symptoms do not improve?

Stop use and consult a doctor if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days.

Packaging Info

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

Packaging configurations for Adwe Childrens Pain Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 68163-695-04. Adwe Children’s Pain+Fever Relief is an oral suspension containing acetaminophen as the active ingredient, formulated as a pain reliever and fever reducer. Each 5 mL dose delivers 160 mg of acetaminophen. The product is designed for children aged 2 to 11 years and is presented in a 4 FL. OZ. (120 mL) bottle. It is dye-free, sugar-free, and contains no added alcohol, with a naturally flavored cherry taste. This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., the distributor of Children’s Tylenol® Dye-Free Oral Suspension. Manufactured for Adwe Laboratories, located at 1274 49 Street, Brooklyn, NY 11219.

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, 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 pediatric use only and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference.

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup, which is specifically designed for use with this product. The dose may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

Dosage Chart:

  • For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

It is imperative to use only the enclosed dosing cup and not any other dosing device to ensure accurate dosing.

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 dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly.

General Precautions Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin. It is critical to adhere to the recommended dosage to avoid the risk of overdose.

Emergency Medical Help In the event of an overdose, immediate medical attention is necessary. Caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Healthcare professionals should instruct caregivers to stop the use of this product and consult a physician if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are warned that severe liver damage may occur if more than five doses are taken within a 24-hour period, which is the maximum daily amount, or if it is used concurrently with other medications containing acetaminophen.

Allergic reactions may also occur, with acetaminophen potentially causing severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Patients should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is advised to consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the acetaminophen content of other medications should consult a doctor or pharmacist. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Before using this product, it is recommended that patients consult a doctor if they have liver disease or if they are taking the blood-thinning medication warfarin.

While using this product, patients must adhere to the recommended dosage to avoid overdose. They should stop use and consult a doctor if pain worsens or lasts more than five days, if fever worsens or lasts more than three 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, immediate medical help should be sought, or contact with a Poison Control Center is advised. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

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 Adwe Childrens Pain Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Adwe Childrens Pain Fever.
Details

Pediatric Use

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

It is critical not to exceed 5 doses within a 24-hour period to avoid the risk of severe liver damage. Administration should be performed using only the enclosed dosing cup designed for this product; other dosing devices are not recommended.

Healthcare professionals should be aware of specific warnings: acetaminophen may lead to severe skin reactions, and if any skin reaction occurs, use should be discontinued immediately, and medical assistance sought. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Consultation with a healthcare provider is also advised if the pediatric patient has liver disease or is concurrently taking the blood-thinning medication warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is primarily indicated for children ages 2 to 11 years.

Given the absence of dosage adjustments or safety concerns mentioned for elderly patients, healthcare providers should exercise caution when considering this product for geriatric patients. It is advisable to monitor these patients closely, as individual responses may vary.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential risks and benefits. It is advisable to monitor any available updates or emerging data related to the use of this product in pregnant individuals.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised. Acetaminophen is generally considered safe for use during breastfeeding, but it is recommended to monitor the infant for any adverse effects.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The presence of acetaminophen in this formulation necessitates caution, as severe liver damage may occur if the patient exceeds five doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk of liver damage is heightened when this product is used concurrently with other medications containing acetaminophen. Therefore, careful monitoring of liver function and adherence to dosing guidelines is essential to mitigate the risk of hepatotoxicity in patients with compromised liver function.

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 medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and intervention may be necessary to address any complications that arise during the course of treatment.

It is vital to maintain open communication with poison control and other medical professionals to ensure the best possible outcomes for patients experiencing an overdose.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

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. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if the child's pain worsens or persists for more than five days, or if a fever worsens or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, including the potential for overdose. Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Adwe Childrens Pain 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 Adwe Childrens Pain 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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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.