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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
April 25, 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
April 25, 2024
Manufacturer
Dolgencorp Inc
Registration number
M013
NDC root
55910-010
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 minor aches and pains in children, as well as to reduce fever. It is available in a cherry-flavored oral suspension, specifically formulated for children aged 2 to 11 years, with a concentration of 160 mg per 5 mL. This medication is alcohol-free, aspirin-free, and ibuprofen-free, making it a gentle option for young ones.

When your child has a common cold, flu, headache, sore throat, or toothache, acetaminophen can provide fast and effective relief from discomfort. It works by targeting the areas in the body that signal pain and fever, helping your child feel better quickly.

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 provide you with relief when you're feeling unwell, making it easier to manage everyday discomforts.

Dosage and Administration

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

To give the medication, remove the child protective cap and squeeze the correct dose into the dosing cup provided. You can repeat this dose every 4 hours as long as your child’s symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide the correct measurement.

What to Avoid

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

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

Side Effects

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.

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. Additionally, you should stop use and contact a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition. Always consult a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin.

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 that also contain acetaminophen. It's important to be aware of potential severe 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.

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 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 an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if no symptoms are present, as quick medical attention is crucial.

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. Even if you don’t notice any signs or symptoms, getting quick medical attention is crucial, as some effects may not be immediately apparent.

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. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. However, the insert does not indicate any known risks or contraindications associated with using acetaminophen while pregnant. Additionally, there are no dosage modifications recommended for pregnant individuals, and no special precautions are noted.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since the insert does not provide guidance on these topics, it may be wise to consult your healthcare provider for personalized advice. They can help you understand any potential risks and make informed decisions about your health and your baby's well-being.

Pediatric Use

When giving this 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 2-3 years and weighing between 24-35 pounds, the dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 pounds), 10 mL for ages 6-8 years (48-59 pounds), 12.5 mL for ages 9-10 years (60-71 pounds), and 15 mL for 11-year-olds (72-95 pounds). Remember, do not exceed 5 doses in a 24-hour period.

Always use the dosing cup that comes with the product, as other devices may not provide the correct amount. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor or pharmacist before use. If your child's pain worsens or lasts more than 5 days, or if a fever persists for more than 3 days, stop use and seek medical advice. In case of an overdose, contact a Poison Control Center immediately, as prompt medical attention is crucial.

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 tailored advice and guidance on how to use this product safely and effectively.

Always prioritize open communication with your doctor about any health conditions or medications you are currently taking, as this will help ensure the best care and minimize any potential risks.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. They can provide guidance tailored to your specific situation. Additionally, if your child has liver disease, you should also seek medical advice before use. This ensures that any potential risks are managed appropriately and that the treatment is safe for you or your child. Always prioritize open communication with your healthcare provider regarding your kidney health.

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 it's safe and appropriate for your child. Always prioritize their health by seeking professional advice 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 lead to serious health issues, 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 using the product, check the printed neckband; do not use it if the neckband 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 the product remains safe and effective for your use.

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 seek medical advice. 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.

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 to use during pregnancy?

The insert does not provide specific information regarding the use of Acetaminophen during pregnancy.

What should I do in case of an overdose?

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

What flavor does Acetaminophen come in?

Acetaminophen is available in a cherry flavor.

Is Acetaminophen free from certain ingredients?

Yes, Acetaminophen is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free.

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

Acetaminophen is presented in an oral suspension formulation, delivering 160 mg of acetaminophen per 5 mL. This product is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free, ensuring a suitable option for patients with sensitivities to these compounds. The suspension is flavored with cherry, enhancing palatability. Each bottle contains 4 fluid ounces (118 mL) of the product.

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 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 below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup. 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 (2-3 years), the dose is 5 mL.

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

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

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

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

Use only the enclosed dosing cup specifically designed for this product; do not utilize any other dosing device.

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 a medication, consultation with a healthcare professional is advised.

  • In patients with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

  • Exceeding the recommended dose is contraindicated due to the potential for overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise 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, as this may further increase the risk of liver injury.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is recommended.

Patients should be instructed to stop using the product and consult a healthcare professional if any of the following occur: pain worsens or lasts longer than 5 days, fever worsens or persists beyond 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

In cases of suspected overdose, immediate medical attention is crucial. Patients or caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is essential.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if a child exceeds five doses within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients should be monitored for signs of liver injury, particularly in those with pre-existing liver disease.

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

Participants should also be aware of the sore throat warning. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Furthermore, it is recommended to seek medical advice before using this product if the child has liver disease or is concurrently taking the blood-thinning medication warfarin.

Drug Interactions

The concomitant use of this medication with warfarin, a blood-thinning agent, should be approached with caution. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment if they are currently taking warfarin. This is to ensure appropriate monitoring and management of potential interactions that may affect coagulation parameters.

Additionally, this medication should not be used in conjunction with other products containing acetaminophen, whether they are prescription or nonprescription. Patients are encouraged to verify the presence of acetaminophen in any other medications they may be taking. If there is uncertainty regarding the contents of a medication, it is recommended to seek guidance from a healthcare professional to avoid the risk of acetaminophen overdose.

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 3 years weighing 24-35 lb, the recommended dose is 5 mL; for those aged 4 to 5 years weighing 36-47 lb, the dose is 7.5 mL; for children aged 6 to 8 years weighing 48-59 lb, the dose is 10 mL; for those aged 9 to 10 years weighing 60-71 lb, the dose is 12.5 mL; and for 11-year-olds weighing 72-95 lb, the dose is 15 mL.

It is advised to use weight for dosing whenever possible; otherwise, age may be used. The maximum daily amount is 5 doses within a 24-hour period. Only the enclosed dosing cup specifically designed for this product should be used; other dosing devices are not recommended.

Healthcare professionals should advise parents to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. Parents should be instructed to stop use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms occur, or if redness or swelling is observed.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is essential, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when considering this product for geriatric patients, as the absence of comprehensive information may impact safety and efficacy. It is essential to monitor these patients closely and consider alternative therapies that provide clearer dosing and safety profiles.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of acetaminophen in pregnant patients. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product in this population. Healthcare professionals should consider the absence of data when advising women of childbearing potential and pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

Renal Impairment

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

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 adjustments in dosage 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 potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention can significantly impact the outcome of an overdose situation. Therefore, it is crucial to act swiftly, regardless of the presence of overt symptoms.

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. 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 beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

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 should 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

Patients should be informed that 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 are also cautioned to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. It is essential 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 (1-800-222-1222) should be made.

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.