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Dg Health 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 2015
Label revision date
May 22, 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 2015
Label revision date
May 22, 2024
Manufacturer
Dolgencorp, LLC
Registration number
M013
NDC root
55910-251
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Acetaminophen is a medication commonly used to relieve pain and reduce fever in children aged 2 to 11 years. It comes in an oral suspension form, with a grape flavor, making it easier for kids to take. This medication is alcohol-free, aspirin-free, and ibuprofen-free, providing a safe option for managing minor aches and pains associated with conditions like the common cold, flu, headache, sore throat, and toothache.

As a pain reliever and fever reducer, acetaminophen works quickly to provide effective relief, helping your child feel more comfortable during times of illness.

Uses

You can use this medication to help 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 medication is designed to make you feel more comfortable when you're dealing with these everyday ailments. If you're experiencing any of these symptoms, it may be a helpful option for you.

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, using the provided dosing chart. For example, if your child weighs between 24 and 35 pounds and is 2 to 3 years old, the dose is 5 milliliters (mL). If your child weighs between 36 and 47 pounds and is 4 to 5 years old, the dose increases to 7.5 mL. Always use the dosing cup that comes with the product to ensure accuracy.

Once you have the right dose, remove the child protective cap and squeeze the measured amount into the dosing cup. You can repeat this dose every 4 hours as long as your child has symptoms, but remember not to give more than 5 doses in a 24-hour period. If your child weighs less than 24 pounds or is under 2 years old, it’s best to consult a doctor for the appropriate dosage. Always follow these guidelines carefully to ensure your child's safety.

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, if your child has ever had an allergic reaction to this product or any of its ingredients, do not use it.

While using this medication, make sure to follow the recommended dosage carefully and avoid exceeding it, as doing so can lead to serious health risks. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

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 healthcare professional if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is any redness or swelling, as these could indicate a serious condition.

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. It's important to be aware of potential severe skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately.

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. You should also stop using the product and call your 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 an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if no symptoms are present. Always consult a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

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, even if you don’t notice any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you experience any of these symptoms or have concerns about an overdose, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

When considering the use of DG Health Children's Pain and Fever (acetaminophen suspension) during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there are no clear guidelines or warnings regarding its use while you are pregnant.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before taking any medication, including over-the-counter options like acetaminophen. They can help you weigh the benefits and risks based on your individual health needs.

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 medication to your child, it's important to follow the correct dosage based on their weight and age. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 11 years, the recommended doses are as follows: 5 mL for children weighing 24-35 pounds (ages 2-3), 7.5 mL for 36-47 pounds (ages 4-5), 10 mL for 48-59 pounds (ages 6-8), 12.5 mL for 60-71 pounds (ages 9-10), and 15 mL for those weighing 72-95 pounds (age 11).

Make sure not to exceed the recommended dose, and do not give the medication more than five times in a 24-hour period. Always consult a doctor if your child has liver disease or has had an allergic reaction to this product. If your child's pain worsens or lasts more than five days, or if their fever persists for more than three days, stop use and seek medical advice. Additionally, watch for any new symptoms or signs of redness and swelling.

Geriatric Use

When considering this medication, it's important to note that it does not provide specific directions or complete warnings for adult use, including older adults. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for personalized guidance.

Always ensure that any medication is appropriate for your health needs, especially if there are existing conditions or medications involved. Your healthcare provider can help determine the right dosage and any necessary precautions to take.

Renal Impairment

If your child has liver disease, it's important to consult with a doctor before using this medication. This ensures that any potential risks are properly managed and that the treatment is safe for your child's specific health needs. Always prioritize open communication with your healthcare provider regarding any existing health conditions.

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 and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before use, always check the printed neckband; do not use the product if it is broken or missing, as this could indicate that the product is compromised.

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

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as symptoms persist, but do not exceed 5 doses in a 24-hour period. It's important to consult a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

If your child's pain worsens or lasts more than 5 days, or if a fever worsens or lasts more than 3 days, stop using the medication and contact a doctor. Additionally, watch for any new symptoms or signs of redness and swelling. Always keep this medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Acetaminophen used for?

Acetaminophen is used to 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 aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

How often can I give Acetaminophen to my child?

You can repeat the dose every 4 hours while symptoms last, but do not give more than 5 doses in 24 hours.

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 in case of an overdose?

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

Can I use Acetaminophen if my child has liver disease?

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

Is Acetaminophen safe during pregnancy or breastfeeding?

The provided information does not include specific statements regarding the use of Acetaminophen during pregnancy or breastfeeding.

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

Stop use and ask a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, or if new symptoms occur.

Packaging Info

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

Packaging configurations for Dg Health Childrens Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This oral suspension is formulated for children aged 2 to 11 years and contains acetaminophen as the active ingredient, providing 160 mg per 5 mL. It serves as a pain reliever and fever reducer, offering fast and effective relief from children's pain and fever. The product is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free, ensuring a safe option for pediatric use. The suspension is presented in a grape flavor and is packaged in an 8 FL OZ (236 mL) bottle.

Uses and Indications

This drug is indicated for the 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 pediatric use only and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage does not exceed the recommended limits, as indicated in the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart below, prioritizing weight for dosing when possible; otherwise, age may be used as a guide.

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 while symptoms persist, but it is important not to exceed 5 doses within a 24-hour period.

Dosage Chart:

  • For children weighing under 24 lb (under 2 years): Consult a doctor for the appropriate dose.

  • For children weighing 24-35 lb (2-3 years): Administer 5 mL.

  • For children weighing 36-47 lb (4-5 years): Administer 7.5 mL.

  • For children weighing 48-59 lb (6-8 years): Administer 10 mL.

  • For children weighing 60-71 lb (9-10 years): Administer 12.5 mL.

  • For children weighing 72-95 lb (11 years): Administer 15 mL.

Dosing should be conducted using only the enclosed dosing cup; other dosing devices are not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be administered concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in patients who have a history of allergic reactions to this product or any of its components.

Exceeding the recommended dosage is also contraindicated due to the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in pediatric patients 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 also contain acetaminophen. Healthcare professionals should monitor patients closely for adherence to dosing guidelines to prevent potential hepatotoxicity.

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 2 days, or if it is accompanied or followed by additional symptoms such as fever, headache, rash, nausea, or vomiting, healthcare providers should be consulted promptly to rule out serious underlying conditions.

Patients should be advised to stop use 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 medical condition requiring further evaluation.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are initially apparent, as prompt intervention can be critical.

Prior to administration, healthcare professionals should inquire about any existing liver disease in pediatric patients. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking the anticoagulant medication warfarin, as potential interactions may necessitate careful monitoring or alternative treatment options.

Side Effects

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

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or who take this product in conjunction with other medications containing acetaminophen.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious 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 recommended that they consult a healthcare professional promptly.

Patients are advised to stop using the product and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if there is any redness or swelling present. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. 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 Dg Health Childrens Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dg Health Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 11 years, the recommended dosing is as follows: for those weighing under 24 lb, a physician's advice is necessary; for weights between 24-35 lb (ages 2-3 years), the dose is 5 mL; for 36-47 lb (ages 4-5 years), the dose is 7.5 mL; for 48-59 lb (ages 6-8 years), the dose is 10 mL; for 60-71 lb (ages 9-10 years), the dose is 12.5 mL; and for 72-95 lb (age 11 years), the dose is 15 mL.

It is crucial not to exceed the recommended dose, as an overdose warning is in place. The medication should not be administered more than five times within a 24-hour period. Parents or caregivers should seek medical advice before use if the child has liver disease or has previously experienced an allergic reaction to this product or any of its ingredients.

If pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, parents or caregivers should discontinue use and consult a doctor.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Monitoring for adverse effects and therapeutic efficacy is recommended, as elderly patients may have an altered pharmacokinetic and pharmacodynamic profile. Dose adjustments may be necessary based on individual patient assessments and clinical judgment.

Pregnancy

There are no specific statements regarding the use of DG Health Children's Pain and Fever (acetaminophen suspension) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that healthcare providers exercise caution and discuss the use of this medication with pregnant patients, taking into account individual circumstances and the overall clinical context.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to evaluate the patient's overall health status, as reduced kidney function may necessitate careful monitoring and potential dosing adjustments.

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. Close monitoring of liver function tests may be warranted to ensure safety and efficacy 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 essential, as the absence of noticeable signs or symptoms does not preclude the possibility of serious health consequences.

Healthcare professionals should be aware that quick medical attention is critical in managing potential overdose situations. Even in the absence of overt symptoms, the risk of delayed reactions necessitates thorough evaluation and monitoring of the patient.

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 understanding of potential risks associated with the compound in nonclinical settings.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Healthcare professionals are advised to inspect the product prior to use; it must not be utilized if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor before use if the patient has liver disease or is taking warfarin, a blood-thinning medication. Patients should discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center should be made at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Dg Health 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 Dg Health 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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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.