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Dye Free Childrens Acetaminophen

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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 2022
Label revision date
January 16, 2025
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 2022
Label revision date
January 16, 2025
Manufacturer
Precision Dose Inc.
Registration number
M013
NDC root
68094-061
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Children's Acetaminophen is an oral suspension medication that contains 160 mg of acetaminophen per 5 mL. It is commonly used to reduce fever and relieve minor aches and pains associated with conditions such as the common cold, flu, headache, sore throat, and toothache. This formulation is dye-free, making it a suitable option for children who may be sensitive to artificial colors.

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 medication, make sure to follow the instructions provided by your healthcare professional. It's important to note that this product does not include complete directions or warnings for adult use, so be cautious and do not exceed the recommended dosage. Always shake the bottle well before using it.

To determine the right dose, refer to the dosage chart based on your child's weight. If possible, use their weight for a more accurate dose; otherwise, you can use their age. You can repeat the dose every 4 hours as long as symptoms persist, but remember not to give more than 5 doses in a 24-hour period. For example, if your child weighs between 24-35 pounds and is 2-3 years old, the dose would be 5 mL. Always consult with a doctor if your child is under 2 years old or if you have any questions about the appropriate dosage.

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 product, make sure to not exceed the recommended dose to avoid the risk of overdose. Always follow the guidelines provided to ensure safe use.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. You should be cautious about liver damage, which can occur if your child takes more than five doses in 24 hours or combines it with other medications containing acetaminophen. Additionally, be alert for severe skin reactions, such as skin reddening, blisters, or rashes. If any of these symptoms appear, stop using the medication and seek medical help immediately.

If your child has a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. It's also crucial to avoid using this medication with any other acetaminophen-containing products and to seek medical advice if your child has liver disease or is taking blood thinners like warfarin. If pain or fever worsens or lasts longer than the recommended time, or if new symptoms develop, stop use and contact a healthcare professional. In case of overdose, seek medical help immediately, even if no symptoms are present.

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. 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. 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 thinner warfarin. In case of an overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 immediately, even if there are no noticeable 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 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 or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial, even if you don’t see 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 notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of acetaminophen during pregnancy has not been fully established. There may be potential risks to your developing baby, and further studies are needed to better understand these risks. Therefore, you should consult your doctor before using acetaminophen, especially if you are considering taking it.

If your healthcare provider determines that you can use acetaminophen, be aware that dosage adjustments may be necessary. Always discuss your specific situation with a healthcare professional to ensure you are using it safely and only when clearly needed.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When giving this medication to your child, it's important to follow the dosage guidelines carefully to ensure their safety. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24 to 35 pounds, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4 to 5 years (36-47 pounds), 10 mL for ages 6 to 8 years (48-59 pounds), 12.5 mL for ages 9 to 10 years (60-71 pounds), and 15 mL for 11-year-olds (72-95 pounds).

Always keep this medication out of reach of children, and never exceed the recommended dose, as doing so can lead to an overdose. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if your child shows no symptoms. Additionally, consult a doctor before use if your child has liver disease to ensure their safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the usual guidelines for safety and precautions that apply to elderly patients have not been established.

If you are an older adult or a caregiver, it's important to consult with a healthcare professional before starting this medication. They can provide personalized advice and ensure that it is safe and appropriate for your individual health needs.

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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If your child has liver disease, it’s important to consult 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 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 of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You should use this medication exactly as directed by your healthcare professional. If needed, you can take a repeat dose every 4 hours while your symptoms persist, but be careful not to exceed 5 doses in a 24-hour period. Always follow your healthcare provider's instructions for the best results.

FAQ

What is Children's Acetaminophen used for?

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

How should I administer Children's Acetaminophen?

You should use the product as directed by a healthcare professional, shaking well before use and repeating the dose every 4 hours while symptoms last, without exceeding 5 doses in 24 hours.

What is the dosage for Children's Acetaminophen based on weight?

The dosage varies by weight: for children weighing 24-35 lbs (2-3 years), it's 5 mL; for 36-47 lbs (4-5 years), it's 7.5 mL; and for 48-59 lbs (6-8 years), it's 10 mL, among others.

Are there any warnings associated with Children's 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 Children's Acetaminophen if my child has liver disease?

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

Is it safe to use Children's Acetaminophen during pregnancy?

The safety of acetaminophen during pregnancy has not been established, and you should consult a doctor before use if pregnant or planning to become pregnant.

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.

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

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

Packaging Info

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

Packaging configurations for Dye Free Childrens Acetaminophen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Acetaminophen is an oral suspension formulation containing 160 mg of acetaminophen per 5 mL. This product is dye-free and is manufactured by Precision Dose, Inc., located in South Beloit, IL 61080. The National Drug Code (NDC) for this formulation is 68094-061-59.

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 should be used as directed by a healthcare professional. It is important to note that this product does not contain complete directions or warnings for adult use. Healthcare professionals should ensure that the dosage does not exceed the recommended limits, as an overdose may occur.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosage chart provided below. When possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a guide. Doses 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 patients weighing under 24 lb (under 2 years of age): Consult a doctor for the appropriate dose.

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

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

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

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

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

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

This product should not be administered to children who have a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse effects.

Additionally, exceeding the recommended dose is contraindicated, as it poses a significant 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 if the product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should instruct caregivers to consult a physician if a child experiences a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken when administering this product. Caregivers should be advised to consult a doctor prior to use if the child has a history of liver disease. Furthermore, it is essential to seek guidance from a healthcare professional or pharmacist if the child is currently taking the anticoagulant warfarin.

In cases of suspected overdose, immediate medical attention is critical. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Caregivers should also be informed to discontinue use and consult a physician 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 medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who take the medication concurrently with other drugs containing acetaminophen. Patients should be aware that acetaminophen can lead to severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional without delay. It is advised that patients do not use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist. Additionally, this medication should not be used by individuals who have a history of allergic reactions to this product or any of its ingredients.

Before using this medication, patients with liver disease should seek guidance from a healthcare provider. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

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

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential, even if no signs or symptoms are immediately 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 may arise from unintentional duplication of therapy. 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 Dye Free Childrens Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dye Free Childrens Acetaminophen.
Details

Pediatric Use

Pediatric patients should not exceed the recommended dosage. For children under 2 years of age and weighing less than 24 pounds, a healthcare professional should be consulted before administration. The following dosing guidelines apply for children aged 2 years and older:

  • For children weighing 24-35 pounds (2-3 years): 5 mL

  • For children weighing 36-47 pounds (4-5 years): 7.5 mL

  • For children weighing 48-59 pounds (6-8 years): 10 mL

  • For children weighing 60-71 pounds (9-10 years): 12.5 mL

  • For children weighing 72-95 pounds (11 years): 15 mL

It is important to ask a doctor before use if the child has liver disease. The 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 medical attention is crucial even if no signs or symptoms are observed.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of acetaminophen in this population.

Dosage adjustments may be necessary, and it is essential for healthcare providers to guide any modifications. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare provider regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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

Acetaminophen has been associated with reports of severe skin reactions in the postmarketing setting. Symptoms of these reactions may 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 that this product should not be used in conjunction with any other medication containing 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 history of allergic reactions to it or any of its ingredients. They should be instructed to discontinue use and seek medical advice 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.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and inform patients about the risks associated with exceeding this dose, referencing the overdose warning. Additionally, patients should be advised to consult a doctor before using this product if their child has liver disease. It is also recommended that patients 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 various package configurations, with specific NDC numbers available for 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. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

Patients should use the medication as directed by their healthcare professional. The recommended dosing frequency is every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Dye Free Childrens Acetaminophen, 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 Dye Free Childrens Acetaminophen, 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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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.