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Signature Care Childrens Pain Relief

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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
September 6, 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
September 6, 2024
Manufacturer
Safeway
Registration number
M013
NDC root
21130-243
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 children's pain relief oral suspension designed for kids aged 2 to 11 years. Each 5 mL dose contains 160 mg of acetaminophen, which is a medication that helps reduce fever and relieve minor aches and pains associated with common conditions like the cold, flu, headaches, sore throats, and toothaches. This product comes in a pleasant cherry flavor and is available in a 4 FL OZ (118 mL) bottle.

This formulation is free from ibuprofen, aspirin, alcohol, and parabens, making it a suitable option for parents looking for a safe way to manage their child's discomfort.

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 you use this medication, make sure to shake the bottle well. It's important to follow the dosing instructions carefully to ensure safety and effectiveness. You should find the right dose based on your child's weight, and if that's not possible, you can use their age instead. For children weighing under 24 pounds (under 2 years), it's best to consult a doctor before giving any dose.

For children who weigh between 24 and 35 pounds (ages 2-3), the recommended dose is 5 mL. If your child weighs between 36 and 47 pounds (ages 4-5), the dose increases to 7.5 mL. For those weighing 48 to 59 pounds (ages 6-8), the dose is 10 mL, and for children weighing 60 to 71 pounds (ages 9-10), the dose is 12.5 mL. Finally, if your child weighs 72 to 95 pounds (11 years), the dose is 15 mL. Remember to use the dosing cup that comes with the medication, as it is specifically designed for this product.

You can repeat the dose every 4 hours while your child is experiencing symptoms, but do not give more than 5 doses in a 24-hour period. Always be cautious and do not exceed the recommended amount. If you have any questions or concerns, consult your doctor for guidance.

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 be cautious not to exceed it, as doing so can lead to serious health risks.

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 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 check with a doctor before use if your child has liver disease or is taking the blood thinner 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 at 1-800-222-1222 immediately, even if no symptoms are present. Quick medical attention is crucial.

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, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

While the information provided does not specifically address the use of this medication during pregnancy, there are no explicit safety concerns or dosage modifications indicated for pregnant individuals. This means that, based on the available data, there are no special precautions required when considering this medication during pregnancy.

However, it is always best to consult with your healthcare provider before starting any new medication if you are pregnant or planning to become pregnant. They can provide personalized advice and ensure that you make informed decisions for your health and the health of your baby.

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. This means that, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

However, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about medications and breastfeeding, as they can provide personalized advice based on your situation.

Pediatric Use

When giving this medication to children aged 2 to 11 years, it's important to follow the dosing guidelines based on their weight. For children under 24 pounds, you should consult a doctor before use. For those weighing between 24 and 95 pounds, the dosage varies: children aged 2-3 years should receive 5 mL, 4-5 years should get 7.5 mL, 6-8 years should have 10 mL, 9-10 years should take 12.5 mL, and 11 years old should receive 15 mL. Always use weight for dosing when possible; otherwise, use age.

Be cautious not to exceed 5 doses in a 24-hour period. If your child has liver disease or is taking the blood-thinning medication warfarin, consult a doctor before use. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if your child shows no symptoms. Quick action is essential.

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 medication safely and effectively.

Always ensure that any medication you take is appropriate for your age and health status, as older adults may have different needs and considerations compared to younger individuals. Your healthcare provider can help you understand any potential risks and adjust dosages if necessary.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider may need to adjust your dosage or monitor your condition closely to ensure your safety. This is especially crucial if you have any other health issues, such as liver disease, as these can affect how your body processes medications. Always keep your doctor informed about your kidney health and any other medical conditions you may have.

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 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 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 ensure that 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 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: for children weighing 24-35 lb (2-3 years), it's 5 mL; for 36-47 lb (4-5 years), it's 7.5 mL; and so on, up to 15 mL for those weighing 72-95 lb (11 years).

How often can I give Acetaminophen to my child?

You can repeat the dose every 4 hours while symptoms last, but do not exceed 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 right away 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 for children under 2 years?

For children under 24 lb (under 2 years), you should ask a doctor before administering Acetaminophen.

Does Acetaminophen contain any allergens?

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

Is Acetaminophen safe during pregnancy or breastfeeding?

The provided information does not specify safety concerns regarding the use of Acetaminophen during pregnancy or breastfeeding.

Packaging Info

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

Packaging configurations for Signature Care Childrens Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Signature Care Childrens Pain Relief, 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 serves as a pain reliever and fever reducer. Each 5 mL dose contains 160 mg of acetaminophen, providing effective relief comparable to Children’s Tylenol® Oral Suspension. The product is cherry-flavored and is free from ibuprofen, aspirin, alcohol, and parabens. It is packaged in a 4 FL OZ (118 mL) bottle, ensuring quality and safety for pediatric use.

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

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided below, with weight being the preferred method for dosing; if weight is not available, age may be used as a secondary reference.

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

Dosing Chart:

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

  • 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 may also be adjusted as directed by a physician. It is crucial to adhere strictly to the dosing recommendations and to avoid administering more than the directed amount, as indicated in the overdose warning.

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

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the recommended guidelines. Healthcare professionals should advise caregivers that the maximum daily dosage for children is five doses within a 24-hour period. Caution is particularly warranted when this product is administered concurrently with other medications containing acetaminophen, as this can lead to unintentional overdose.

Acetaminophen may also provoke severe skin reactions, which can 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.

Healthcare providers should be vigilant regarding the management of 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, 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 five days, fever worsens or persists beyond three days, new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no signs or symptoms are apparent. Quick intervention is essential to mitigate potential health risks associated with acetaminophen overdose.

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 if the product is taken concurrently 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 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 promptly.

It is also recommended that patients stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Furthermore, patients should seek medical advice before using this product if they have liver disease or if they are taking the blood-thinning medication warfarin.

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. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. 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 Signature Care Childrens Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Childrens Pain Relief.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive dosing based on weight and age. For children under 24 lb and under 2 years of age, consultation with a doctor is advised prior to use. For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 5 mL; for 36-47 lb (ages 4-5 years), 7.5 mL; for 48-59 lb (ages 6-8 years), 10 mL; for 60-71 lb (ages 9-10 years), 12.5 mL; and for 72-95 lb (age 11 years), 15 mL.

Dosing should primarily be determined by weight; however, age may also be used as a guideline. It is critical not to exceed 5 doses within a 24-hour period. Caution is advised, and a doctor should be consulted if the child has liver disease or is taking the anticoagulant warfarin. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is essential even if no symptoms are present.

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 and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to evaluate the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no explicit statements regarding safety concerns or dosage modifications for pregnant individuals. Additionally, no special precautions regarding the use of this medication during pregnancy have been mentioned. Healthcare professionals are encouraged to weigh the potential benefits against any unknown risks when considering this medication for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

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 assess the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols based on the severity of renal impairment.

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 quick medical attention can significantly impact the outcome, 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 complications. Therefore, monitoring and evaluation should be conducted as soon as possible following an overdose incident.

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 use of the compound in these contexts.

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 use 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

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 Signature Care Childrens Pain Relief, 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 Signature Care Childrens Pain Relief, 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.