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Good Neighbor Pharmacy Childrens Pain and Fever

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Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1993
Label revision date
May 13, 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 1993
Label revision date
May 13, 2025
Manufacturer
Amerisource Bergen
Registration number
M013
NDC root
46122-210
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Acetaminophen is a medication commonly used to reduce fever and relieve minor aches and pains in children aged 2 to 11 years. It is effective for discomfort caused by conditions such as the common cold, flu, headaches, sore throats, and toothaches. This formulation is available as a cherry-flavored oral suspension, making it easier for children to take.

One of the key benefits of acetaminophen is that it is free from aspirin, ibuprofen, alcohol, and parabens, making it a suitable option for many families. With a concentration of 160 mg per 5 mL, it provides a gentle yet effective way to help manage your child's symptoms.

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 shake the bottle well. You’ll need to measure the correct dose based on your child's weight or age, using the provided dosing chart. For example, if your child weighs between 24 and 35 pounds and is 2 to 3 years old, the dose is 5 milliliters (mL). If your child weighs between 36 and 47 pounds and is 4 to 5 years old, the dose increases to 7.5 mL. Always use the dosing cup that comes with the product to ensure accuracy.

Once you have the right dose, remove the child protective cap and squeeze the measured amount into the dosing cup. You can repeat this dose every 4 hours as long as your child continues to have symptoms, but remember not to give more than 5 doses in a 24-hour period. If your child is under 24 pounds or under 2 years old, it’s best to consult a doctor for the appropriate dosage. Always follow these guidelines carefully to ensure your child's safety.

What to Avoid

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

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

Side Effects

You should be aware that 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, there is a risk of serious skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately.

It's important to consult a doctor if your child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. You should also 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 may 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. 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.

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 considering the use of Amerisource Bergen Children's Pain and Fever (acetaminophen suspension) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before taking any medication, including over-the-counter options like acetaminophen. They can provide personalized advice based on your health needs and the specifics of your pregnancy.

Lactation Use

If you are breastfeeding and considering using Amerisource Bergen Children's Pain and Fever (acetaminophen suspension), you can feel reassured that there are no specific warnings or considerations mentioned for nursing mothers in the drug insert. This means that, based on the available information, it is generally considered safe for you to use this medication while breastfeeding.

However, as with any medication, it's always a good idea to consult with your healthcare provider before starting any new treatment. They can provide personalized advice based on your individual health needs and circumstances.

Pediatric Use

When giving this medication to your child, it's important to follow the recommended dosages based on their weight and age. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before use. For those aged 2 to 11 years, the doses are as follows: 5 mL for children 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).

Make sure not to exceed the recommended dose and do not give the medication more than five times in a 24-hour period. Always use the dosing cup that comes with the product, as other devices may not provide accurate measurements. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor or pharmacist before use. If your child's pain worsens, lasts more than five days, or if they develop new symptoms, stop use and seek medical advice. Keep the medication out of reach of children, and in case of overdose, contact a Poison Control Center immediately.

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 for personalized guidance.

Always discuss any existing health conditions or medications with your doctor, as they can help determine the safest and most effective dosage for you. Your healthcare provider can also monitor for any potential side effects or interactions that may be more relevant for older adults.

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 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 guidance.

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. Combining these medications can increase the risk of bleeding, so ensuring that your healthcare provider is aware of all medications your child is taking is crucial for their safety. Always prioritize open communication about any treatments or tests to avoid 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 symptoms persist, but do not exceed 5 doses in a 24-hour period. It's important to consult a doctor before use if your child has liver disease or is taking the blood thinner warfarin.

If your child's pain worsens or lasts more than 5 days, or if a fever worsens or lasts more than 3 days, stop using the medication and consult a doctor. Additionally, seek medical help immediately in case of an overdose, even if there are no noticeable symptoms; you can contact a Poison Control Center at 1-800-222-1222. Always keep this medication out of reach of children.

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 acetaminophen?

The dosage varies by weight and age. For example, children aged 2-3 years weighing 24-35 lbs should take 5 mL, while those aged 11 years weighing 72-95 lbs should take 15 mL.

How often can I give acetaminophen to my child?

You can repeat the dose every 4 hours while symptoms last, but do not give more than 5 doses in 24 hours.

Are there any warnings associated with acetaminophen?

Yes, acetaminophen can cause severe liver damage if more than 5 doses are taken in 24 hours or if used with other drugs containing acetaminophen. It may also cause severe skin reactions.

Can I use acetaminophen if my child has liver disease?

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

Is acetaminophen safe to use during pregnancy?

The provided drug insert does not contain specific information regarding the use of acetaminophen during pregnancy.

What should I do in case of an overdose?

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

What should I do if my child's symptoms do not improve?

Stop use and ask 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 Good Neighbor Pharmacy Childrens Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Good Neighbor Pharmacy Childrens Pain and Fever.
Details

Drug Information (PDF)

This file contains official product information for Good Neighbor Pharmacy Childrens Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Acetaminophen oral suspension contains 160 mg of acetaminophen per 5 mL. This formulation is designed as a fever reducer and pain reliever. It is free from aspirin, ibuprofen, alcohol, and parabens. The product is presented in a cherry flavor and is packaged in a 4 fl oz (118 mL) bottle.

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 complete directions or warnings for adult use. Healthcare professionals should ensure that the dosage does not exceed the recommended limits, as indicated in the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup. The dose may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

Dosage Chart:

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

  • 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 should be as directed by a healthcare professional. It is imperative to use only the enclosed dosing cup specifically designed for this product; other dosing devices should not be utilized.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product is contraindicated in patients with a known history of allergic reactions to this product or any of its components.

Additionally, it is essential to adhere to the recommended dosage, as exceeding this may lead to 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 patients that exceeding five doses within a 24-hour period, which constitutes the maximum daily amount, or concomitant use with other medications containing acetaminophen can lead to serious hepatic injury.

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.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

Healthcare providers should counsel patients to discontinue use and seek medical advice if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists beyond three 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.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no symptoms are apparent. Quick intervention is essential to mitigate potential harm.

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 five doses within a 24-hour period or who take this product 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 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 necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

Packaging & NDC

Below are the non-prescription pack sizes of Good Neighbor Pharmacy Childrens Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Good Neighbor Pharmacy 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, dosing is based on weight, with the following recommendations:

  • For children weighing under 24 lb (under 2 years), consult a doctor.

  • For those weighing 24-35 lb (2-3 years), the dose is 5 mL.

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

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

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

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

It is important not to exceed the recommended dose and to limit administration to no more than 5 doses in a 24-hour period. If weight is not available, age may be used for dosing. The enclosed dosing cup specifically designed for this product should be used; other dosing devices are not recommended.

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

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 medical attention is critical even if no signs or 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 essential 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

There is no specific information available regarding the use of Amerisource Bergen Children's Pain and Fever (acetaminophen suspension) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential. Further studies may be necessary to fully understand the implications of acetaminophen use during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation associated with the use of Amerisource Bergen Children's Pain and Fever (acetaminophen suspension). The available data does not indicate any known effects on breastfed infants or excretion in breast milk. Lactating mothers should consult with their healthcare provider for personalized advice regarding the use of this medication while breastfeeding.

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 health status and renal function to determine the appropriateness of treatment and any necessary dosing adjustments. Monitoring of renal function may be warranted to ensure safety and efficacy in this population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as the absence of noticeable signs or symptoms does not preclude the possibility of 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 or absence of symptoms.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified adverse reactions associated with the use of acetaminophen. Reports have included severe skin reactions, which may manifest as symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate 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 consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients are advised to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Good Neighbor Pharmacy 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 Good Neighbor Pharmacy Childrens Pain and Fever, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.