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Signature Care Infants 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 2018
Label revision date
September 10, 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 2018
Label revision date
September 10, 2024
Manufacturer
Safeway
Registration number
M013
NDC root
21130-178
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 designed for infants, specifically formulated as a pain relief oral suspension. It comes in a grape flavor and is free from dyes, alcohol, aspirin, ibuprofen, and parabens. This product is suitable for children aged 2 to 3 years and is typically used to reduce fever and relieve minor aches and pains associated with common conditions like the cold, flu, headaches, sore throats, and toothaches.

By acting on the body's pain and temperature regulation systems, acetaminophen helps provide comfort during times of discomfort. It's important to use this medication with the enclosed syringe for accurate dosing.

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 you use this medication, make sure to shake the bottle well. To find the right dose for your child, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; otherwise, you can use their age. For children under 2 years old and weighing less than 24 pounds, it's best to consult a doctor for the appropriate dose. For children aged 2 to 3 years and weighing between 24 and 35 pounds, the recommended dose is 5 mL.

When you're ready to measure the dose, push the air out of the syringe and insert the tip into the bottle opening. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the liquid back into the bottle. Next, pull the yellow part of the syringe until it reaches the correct dose and stays there. Dispense the liquid slowly into your child's mouth, aiming for the inner cheek. You can repeat this dose every 4 hours as needed, but do not give more than 5 doses in a 24-hour period. Always use the enclosed syringe designed for this product, and make sure to replace the cap tightly to keep it child-resistant.

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 with a 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.

Always follow the recommended dosage and avoid exceeding it, as doing so can lead to serious health risks. If you have any questions or concerns about using this medication, don't hesitate to 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. 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 experiences a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, if new symptoms arise, pain worsens or lasts more than 5 days, or if fever persists for more than 3 days, you should seek medical advice. Always check with a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin. In case of overdose, contact a medical professional or Poison Control Center right away, as prompt attention is crucial.

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 and seek medical help immediately. 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 new symptoms arise, if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, 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

When it comes to using acetaminophen during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before taking acetaminophen. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and 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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks 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 children, it's important to follow specific guidelines to ensure their safety. For children under 2 years old, you should always consult a doctor before use. If your child is between 2 and 3 years old and weighs between 24 and 35 pounds, the recommended dose is 5 mL. If you can, use your child's weight to determine the correct dose; if not, you can use their age as a guide.

Make sure to use the enclosed syringe that comes with the product, as it is specifically designed for accurate dosing. Avoid using any other dosing devices to ensure your child receives the correct amount. Always prioritize your child's health by following these recommendations closely.

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 tailored for adult use. This means that if you or a loved one is an older adult, you should consult with a healthcare professional for personalized guidance. They can help ensure that the medication is safe and appropriate, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare provider to address any concerns or questions you may have.

Renal Impairment

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

Hepatic Impairment

If your child has liver disease, it’s important to consult with a doctor before using this medication. Liver disease can affect how the body processes medications, so your healthcare provider will help determine if this treatment is safe and appropriate for your child. Always prioritize their health by seeking professional 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 contains 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 you use the product safely and effectively.

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 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 no symptoms are apparent. Before using this medication for your child, consult a doctor if they have liver disease or are taking the blood thinner warfarin. Additionally, stop using the medication and consult a doctor if new symptoms arise, if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, or if there is any redness or swelling, as these may indicate a serious condition.

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 age group is Acetaminophen suitable for?

This product is suitable for children aged 2 to 3 years.

How should I administer Acetaminophen?

Use the enclosed syringe to measure the dose. Shake well before using and dispense the liquid slowly into your child's mouth, toward the inner cheek.

What is the maximum dosage for Acetaminophen?

Do not give more than 5 doses in 24 hours, and repeat doses every 4 hours while symptoms last.

Are there any contraindications for using Acetaminophen?

Do not use Acetaminophen with any other drug containing acetaminophen or if your child has had an allergic reaction to this product or its ingredients.

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 are the storage conditions for Acetaminophen?

Store Acetaminophen at 20-25°C (68-77°F) and do not use if the printed neckband is broken or missing.

Can Acetaminophen be used during pregnancy or while nursing?

The insert does not provide specific information regarding the use of acetaminophen during pregnancy or nursing.

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

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

Packaging Info

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

Packaging configurations for Signature Care Infants Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Signature Care Infants Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Acetaminophen is presented in a liquid dosage form, containing 160 mg of the active ingredient per 5 mL. The formulation is free from dyes, alcohol, aspirin, ibuprofen, and parabens. It is flavored with grape to enhance palatability. The product is packaged in a 2 FL OZ (59 mL) container and is intended for use with the enclosed syringe, with additional information available on the side panel.

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 healthcare professionals should refer to the dosing chart for appropriate administration. It is essential to shake the product well before use. The correct dose should be determined based on the child's weight; if weight is not available, age may be used as a guide.

To prepare the dose, healthcare professionals should follow these steps:

  1. Push the air out of the enclosed syringe and insert the syringe tip into the bottle opening.

  2. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

  3. Pull the yellow part of the syringe until it reaches and stays at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

The dosing chart is as follows:

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

  • For children weighing between 24 to 35 pounds or aged 2 to 3 years, the recommended dose is 5 mL.

It is crucial to replace the cap tightly after use to maintain child resistance. Only the enclosed syringe specifically designed for this product should be used; no other dosing devices are acceptable. Healthcare professionals should ensure that the dosage does not exceed the recommended limits and should be aware of 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, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, 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 components.

  • Exceeding the recommended dosage is contraindicated; refer to the overdose warning for further details.

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 five 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.

Severe skin reactions have been associated with acetaminophen use. Symptoms indicative of such reactions 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 be vigilant regarding sore throat symptoms. If a child presents with a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Before administering this product, it is essential to consult a healthcare professional if the child has a history of liver disease. Furthermore, caregivers should seek advice from a doctor or pharmacist if the child is concurrently taking warfarin or any other blood-thinning medication.

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

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if new symptoms arise, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if any redness or swelling occurs, as these may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen.

Patients may also experience 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.

Additionally, patients should be advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

It is recommended that patients stop use and consult a doctor if new symptoms arise, if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, or if redness or swelling occurs, as these may indicate a serious condition.

Patients with a history of liver disease should seek medical advice prior to using this product. Furthermore, it is advisable for patients taking the anticoagulant warfarin to consult a healthcare provider or pharmacist before use.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek medical help right away, 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. 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 Infants Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Signature Care Infants Pain Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product without consulting a doctor. For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24 to 35 pounds. It is advised to determine the appropriate dose based on weight; if weight is not available, age may be used as a guide.

Healthcare professionals should emphasize the importance of using only the enclosed syringe specifically designed for this product, as other dosing devices may lead to inaccurate dosing.

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 assess 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

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are thoroughly evaluated.

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 associated risks to 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 health status, as reduced kidney function may necessitate careful monitoring and potential dosing adjustments.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential 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 is critical in managing overdose situations. Even in cases where patients do not exhibit any overt symptoms, the risk of delayed effects necessitates thorough evaluation and monitoring. It is advisable to follow established protocols for overdose management, which may include supportive care and symptomatic treatment as indicated.

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. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should be instructed not to exceed the recommended dose, as doing so may lead to serious health risks.

Additionally, healthcare providers should encourage patients to consult with a doctor before using this medication if their child has liver disease. It is also important to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin, to ensure safety and avoid potential interactions.

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 potential tampering or compromise of the product's 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 while symptoms persist, not exceeding 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance in the event of an overdose, even if no symptoms are apparent. It is advised to consult a healthcare professional before use if the patient has liver disease or is taking warfarin. Patients should discontinue use and consult a doctor if new symptoms arise, if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, or if there is any redness or swelling, as these may indicate a serious condition.

Drug Information (PDF)

This file contains official product information for Signature Care Infants 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 Infants 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.

Learn more in our Editorial Policy

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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.