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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)
Marketed in the U.S.
Since 2024
Label revision date
May 9, 2024
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 2024
Label revision date
May 9, 2024
Manufacturer
Dolgencorp Inc
Registration number
M013
NDC root
55910-738

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Drug Overview

DG® health is a children's pain reliever and fever reducer that contains acetaminophen (160 mg per 5 mL) in an oral suspension form. It is designed for children aged 2 to 11 years and provides fast, effective relief from minor aches and pains associated with common conditions like the cold, flu, headache, sore throat, and toothache. This product is alcohol-free, aspirin-free, ibuprofen-free, paraben-free, and dye-free, making it a gentle option for your child's needs.

With a pleasant cherry flavor, DG® health helps to reduce fever and alleviate discomfort, ensuring your child feels 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 safe in terms of teratogenic effects, meaning it does not cause birth defects. You can feel confident using it for relief from these common ailments.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To find the right dose for your child, refer to the dosage chart based on their weight or age. If your child weighs less than 24 pounds or is under 2 years old, it's best to consult a doctor for the appropriate dose. For children weighing between 24 to 35 pounds (ages 2-3), the dose is 5 mL; for those weighing 36 to 47 pounds (ages 4-5), it's 7.5 mL; for 48 to 59 pounds (ages 6-8), it's 10 mL; for 60 to 71 pounds (ages 9-10), it's 12.5 mL; and for children weighing 72 to 95 pounds (age 11), the dose is 15 mL.

When administering the medication, remove the child protective cap and squeeze the correct dose into the enclosed dosing cup. You can repeat this dose every 4 hours as long as your child's symptoms persist, but remember not to give more than 5 doses in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide accurate measurements.

What to Avoid

You should avoid using this product if your child has ever had an allergic reaction to it or any of its ingredients. Additionally, do not combine it with any other medications 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.

Always follow the recommended dosage and never exceed it, as doing so can lead to serious health risks. If you have any questions or concerns about using this product, please reach out to a healthcare professional 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. Additionally, be aware that 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.

You should also 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. It's important to stop use and contact a healthcare professional if pain worsens or lasts more than 5 days, fever persists for 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. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you notice any skin reactions, stop using the product immediately and seek medical help. Additionally, if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

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

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Even if you don’t see 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 notice 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

While there is no specific information available about using this product during pregnancy, it is important to note that the insert does not mention any risks or contraindications associated with acetaminophen use during this time. Additionally, there are no dosage modifications recommended for pregnant individuals, nor are there any special precautions outlined.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before taking any medication, including acetaminophen, to ensure it is safe 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 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 administering any medication. For children aged 2 to 11 years, the recommended doses are as follows: 5 mL for those 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).

Always ensure you do not exceed the recommended dose, as an overdose can be dangerous. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor or pharmacist before use. Keep all medications 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, even if there are no visible symptoms.

Geriatric Use

When considering this medication for older adults, it's important to note that the product does not provide specific directions or complete warnings for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional to ensure that the medication is appropriate and safe for your specific health needs.

Always discuss any existing health conditions or medications you are taking with your doctor, as they can help determine the right dosage and monitor for any potential side effects. Your safety and well-being are the top priority, so don't hesitate to ask questions and seek guidance.

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 assessed and managed. Always prioritize your child's health by seeking professional guidance when it comes to their treatment options.

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 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 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 has acetaminophen, don't hesitate to ask a healthcare professional for guidance. Always prioritize open communication about any medications you or your child are taking to prevent potential interactions.

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.

Always handle the product with care to avoid any damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as long as your symptoms persist. However, do not exceed 5 doses in a 24-hour period. It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial even if you don't see any symptoms.

FAQ

What is DG® health used for?

DG® health is used to reduce fever and relieve minor aches and pains in children due to the common cold, flu, headache, sore throat, and toothache.

What is the active ingredient in DG® health?

The active ingredient in DG® health is acetaminophen, which is present at a concentration of 160 mg per 5 mL.

What age group is DG® health suitable for?

DG® health is suitable for children aged 2 to 11 years.

How should I administer DG® health?

You should use the enclosed dosing cup to measure the dose based on your child's weight or age, and repeat the dose every 4 hours while symptoms last, without exceeding 5 doses in 24 hours.

Are there any warnings associated with DG® health?

Yes, you should not exceed the recommended dose, and it should not be used with other drugs containing acetaminophen. Seek medical help if your child experiences severe skin reactions or if symptoms persist.

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.

Is DG® health safe to use during pregnancy?

The insert does not provide specific information regarding the use of DG® health during pregnancy, and no contraindications are mentioned.

Can I use DG® health if my child has liver disease?

You should ask a doctor before using DG® health if your child has liver disease.

What flavors does DG® health come in?

DG® health comes in a cherry flavor.

What should I do if my child has an allergic reaction to DG® health?

If your child has ever had an allergic reaction to DG® health or any of its ingredients, do not use the product and consult a doctor.

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

DG® Health is an oral suspension formulated for children aged 2 to 11 years, designed to provide effective relief from pain and fever. Each 5 mL dose contains 160 mg of acetaminophen, serving as a pain reliever and fever reducer. The product is alcohol-free, aspirin-free, ibuprofen-free, and paraben-free, ensuring a safe option for pediatric use. It is dye-free and features a cherry flavor for palatability. The suspension is presented in an 8 FL OZ (237 mL) bottle, offering a convenient dosage form for administration.

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 advise caregivers to adhere strictly to the dosing guidelines provided.

Before administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary reference.

To administer the dose, caregivers should 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 it is crucial not to exceed 5 doses within a 24-hour period.

Dosage Chart:

  • For children weighing less than 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

  • 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.

Dosing should only be performed using the enclosed dosing cup specifically designed for this product; other dosing devices should not be used. Caregivers must be cautioned against administering more than the directed dose to avoid the risk of overdose.

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 history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

  • Exceeding the recommended dosage is contraindicated, as it poses a risk of overdose.

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

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

Healthcare professionals should advise caregivers to consult a physician prior to administering this product if the child has a history of liver disease. Additionally, it is recommended to seek guidance from a doctor or pharmacist if the child is currently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent, as prompt intervention is vital.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for 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 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 other products containing acetaminophen, whether prescription or over-the-counter. Patients are advised to verify the presence of acetaminophen in any other medications they may be taking by consulting a healthcare provider or pharmacist to avoid unintentional 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 11 years, the recommended dosages based on weight are as follows: for those weighing under 24 lb, a doctor should be consulted; for 24-35 lb (2-3 years), the dose is 5 mL; for 36-47 lb (4-5 years), the dose is 7.5 mL; for 48-59 lb (6-8 years), the dose is 10 mL; for 60-71 lb (9-10 years), the dose is 12.5 mL; and for 72-95 lb (11 years), the dose is 15 mL.

It is crucial not to exceed the recommended dosage, as indicated in the overdose warning. Parents and caregivers should seek medical advice if the child has liver disease or is taking the blood-thinning medication warfarin. Additionally, this product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, as the absence of specific guidance may impact the safety and efficacy of treatment in this population.

It is essential for healthcare providers to monitor elderly patients closely for any adverse effects or complications that may arise due to the lack of tailored dosing information. Adjustments to the dosage may be necessary based on individual patient assessments and clinical judgment.

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 during this period. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data 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 renal function and consider any necessary dosing adjustments or monitoring protocols based on their specific clinical status.

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. Careful evaluation is necessary to ensure the safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is 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 in these areas limits the understanding of the compound's potential effects 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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

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 potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial even if no symptoms are apparent.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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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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.