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Good Sense Pain Reliefchildrens

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This product has been discontinued

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
November 12, 2013
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
November 12, 2013
Manufacturer
Aidarex Pharmaceuticals LLC
Registration number
part343
NDC root
33261-770
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 Oral Suspension is a liquid medication designed for children aged 2 to 11 years. It is used to relieve minor aches and pains, such as those caused by the common cold, flu, headache, sore throat, or toothache, and to reduce fever. This alcohol-free, aspirin-free, and ibuprofen-free formula comes in a pleasant grape flavor, making it easier for children to take.

Each 5 mL dose contains 160 mg of acetaminophen, which is the active ingredient that helps alleviate discomfort and lower fever. This product is comparable to Children’s Tylenol® Oral Suspension, providing a trusted option for parents seeking effective pain relief for their children.

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 under the weather, making it easier to manage your symptoms and feel more comfortable.

Dosage and Administration

Before using this product, it's important to note that it does not come with complete directions or warnings for adult use. Always make sure to follow the recommended dosage carefully to avoid any risk of overdose. Start by shaking the bottle well before each use. To find the right dose for your child, refer to the provided dosage chart, which suggests using their weight for the most accurate measurement. If weight isn't available, you can use their age instead.

When you're ready to give the medication, remove the child-proof cap and squeeze the correct amount into the dosing cup that comes with the product. For children under 24 pounds (under 2 years), it's best to consult a doctor before administering any dose. For children aged 2 to 3 years, the dose is 5 mL (1 teaspoonful), while those aged 4 to 5 years should receive 7.5 mL (1 ½ teaspoons). Children aged 6 to 8 years can take 10 mL (2 teaspoons), and those aged 9 to 10 years should have 12.5 mL (2 ½ teaspoons). Finally, for children who are 11 years old, the dose is 15 mL (3 teaspoons). You can repeat the dose every 4 hours as long as symptoms persist, but remember not to exceed 5 doses in a 24-hour period. Always use the dosing cup provided and avoid using any other measuring devices.

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 ask 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

It's important to be aware of potential side effects when using this product. One significant concern is the risk of severe liver damage, especially if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, you should consult a doctor immediately.

You should also avoid using this product if your child has had an allergic reaction to it or any of its ingredients, or if they are taking the blood-thinning medication warfarin. Be cautious not to exceed the recommended dose, as an overdose can lead to serious liver damage. If pain or fever worsens or lasts longer than the specified time, or if new symptoms arise, seek medical advice promptly. In case of an overdose, contact a medical professional or Poison Control Center right away, even if no symptoms are present.

Warnings and Precautions

This product contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it’s important to consult a doctor right away.

Before using this medication, please check with a doctor if your child has liver disease or is taking the blood thinner warfarin. In case of an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if there are no noticeable symptoms.

You should stop using this product and call your doctor if your child's pain worsens or lasts more than 5 days, if their fever worsens or lasts more than 3 days, if new symptoms appear, or if there is any redness or swelling. These could indicate a more serious condition that needs attention.

Overdose

Taking more than the recommended dose of this medication can lead to serious liver damage. It's important to be aware of this risk and to act quickly if you suspect an overdose.

If you or someone else has taken too much, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if there are no noticeable signs or symptoms of an overdose. Remember, it's always better to be safe and get checked out.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. The insert does not mention any risks or contraindications associated with using acetaminophen while pregnant, and there are no dosage modifications recommended for pregnant individuals. Additionally, no special precautions are outlined for its use in this context.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution when considering its use while breastfeeding.

Pediatric Use

When giving this medication to children aged 2 to 11, it's important to follow the dosing guidelines carefully to ensure their safety. You should always check the dosing chart to find the right amount based on your child's weight or age. For example, if your child weighs between 24-35 pounds (about 2-3 years old), the recommended dose is 5 mL (1 teaspoon). If they weigh 36-47 pounds (4-5 years), the dose increases to 7.5 mL (1.5 teaspoons), and so on, up to 15 mL (3 teaspoons) for an 11-year-old weighing 72-95 pounds.

Make sure to use the dosing cup that comes with the product, as other devices may not provide accurate measurements. It's crucial not to exceed the maximum of 5 doses in 24 hours to avoid severe liver damage. If your child has liver disease or is taking the blood thinner warfarin, consult a doctor before using this medication. Always prioritize your child's health and safety by following these guidelines closely.

Geriatric Use

When it comes to using this product for older adults, there is no specific information available regarding its safety or effectiveness. This means that the product does not have tailored guidelines or warnings for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional before starting any new medication. They can provide guidance based on individual health needs and ensure that the treatment is appropriate and safe. Always prioritize open communication with healthcare providers to address any concerns or questions you may have.

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 you have renal impairment (kidney issues).

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

Hepatic Impairment

If your child has liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, so always stick to the maximum daily amount. Additionally, if your child has liver disease, you should consult a doctor before using any product containing acetaminophen.

Be aware that taking more than the recommended dose can also cause liver damage. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center, even if there are no noticeable symptoms. Quick action is essential in these situations.

Drug Interactions

It's important to talk to your healthcare provider 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 with a doctor or pharmacist first.

Additionally, you should 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 your healthcare provider for guidance. Keeping open communication about all medications is key to ensuring safety and effectiveness.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness and safety.

When handling the product, please check the printed neckband before use. If it is broken or missing, do not use the product, as this could indicate a safety issue. Always prioritize these guidelines to ensure safe and effective use.

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.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you don't notice any signs or symptoms of an overdose.

FAQ

What is Acetaminophen Oral Suspension used for?

Acetaminophen Oral Suspension is used for children's pain relief and as a fever reducer. It helps relieve minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What age group is this medication suitable for?

This medication is suitable for children aged 2 to 11 years.

How should I administer the dosage?

You should find the right dose on the chart based on your child's weight or age. Use the enclosed dosing cup specifically designed for this product.

What is the maximum dosage for children?

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

Are there any warnings associated with this product?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours or with other drugs containing acetaminophen. Consult a doctor if your child has liver disease.

Can I use this product if my child has allergies?

Do not use this product if your child has ever had an allergic reaction to it or any of 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. Quick medical attention is critical even if no signs or symptoms are noticed.

Is it safe to use during pregnancy or while nursing?

There is no specific information regarding the use of this product during pregnancy. Nursing mothers should consult a doctor before use, as the effects on a nursing infant are not well studied.

What flavor does this suspension have?

The Acetaminophen Oral Suspension has a grape flavor.

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

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

Packaging Info

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

Packaging configurations for Good Sense Pain Reliefchildrens.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Acetaminophen Oral Suspension is a suspension liquid formulation designed for the reduction of fever and relief of pain. This product is alcohol-free, aspirin-free, and ibuprofen-free, making it suitable for a wide range of patients. It is flavored with grape to enhance palatability. Each 5 mL dose contains 160 mg of acetaminophen, which is comparable to the active ingredient found in Children’s Tylenol® Oral Suspension. The product is repackaged by Aidarex Pharmaceuticals LLC, located in Corona, CA 92880.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for pediatric use only and does not contain directions or complete warnings for adult use. Healthcare professionals should advise caregivers to adhere strictly to the dosing guidelines provided, ensuring that no more than the recommended dose is administered to avoid the risk of overdose.

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

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

Dosage Recommendations:

  • Under 24 lb (under 2 years): Consult a physician for appropriate dosing.

  • 24-35 lb (2-3 years): Administer 5 mL (1 teaspoonful).

  • 36-47 lb (4-5 years): Administer 7.5 mL (1 ½ teaspoonfuls).

  • 48-59 lb (6-8 years): Administer 10 mL (2 teaspoonfuls).

  • 60-71 lb (9-10 years): Administer 12.5 mL (2 ½ teaspoonfuls).

  • 72-95 lb (11 years): Administer 15 mL (3 teaspoonfuls).

Dosing should only be performed using the enclosed dosing cup specifically designed for this product; caregivers should not use any other dosing device.

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 dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise caregivers to monitor the total intake of acetaminophen from all sources to prevent potential toxicity.

In cases of severe sore throat, it is imperative to consult a physician if the sore throat persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Before administering this product, healthcare providers should inquire about any existing liver disease in the child. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant medication, as interactions may occur.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial, even if no symptoms are initially apparent.

Caregivers should be instructed to discontinue use and consult a healthcare professional if the child experiences worsening pain that lasts more than 5 days, a fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious condition that necessitates further medical investigation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if the product is taken concurrently with other medications containing acetaminophen. Patients are advised to consult a doctor promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should seek medical advice if they are uncertain whether a drug contains acetaminophen. Additionally, individuals with a history of allergic reactions to this product or any of its ingredients should avoid its use.

Before using this product, it is recommended that patients consult a doctor if they have liver disease or are taking the blood-thinning medication warfarin.

While using this product, it is crucial not to exceed the recommended dose. Patients should discontinue use and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms occur, or if redness or swelling is present, as these may indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised. Quick medical attention is critical, 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 Good Sense Pain Reliefchildrens (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Good Sense Pain Reliefchildrens.
Details

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with careful adherence to dosing guidelines. The recommended dosages are based on weight and age, as follows:

  • For children under 24 lb (under 2 years), consultation with a doctor is advised.

  • For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 5 mL (1 teaspoon).

  • For children weighing 36-47 lb (ages 4-5 years), the dose is 7.5 mL (1 ½ teaspoons).

  • For those weighing 48-59 lb (ages 6-8 years), the dose is 10 mL (2 teaspoons).

  • For children weighing 60-71 lb (ages 9-10 years), the dose is 12.5 mL (2 ½ teaspoons).

  • For those weighing 72-95 lb (age 11 years), the dose is 15 mL (3 teaspoons).

It is crucial to use only the enclosed dosing cup specifically designed for this product and to avoid any other dosing devices. Caregivers should not exceed the maximum daily amount of 5 doses in 24 hours, as severe liver damage may occur. Parents should consult a doctor before use if their child has liver disease or is taking the blood-thinning medication warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance tailored to geriatric populations. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for elderly patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits of administering this product to geriatric patients, taking into account the lack of established safety and efficacy data in this demographic. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of treatment in elderly individuals.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of acetaminophen in pregnant patients. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product in this population. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product on a nursing infant are not well studied; therefore, caution is advised.

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 necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is essential to note that severe liver damage may occur if the maximum daily amount of 5 doses is exceeded within a 24-hour period or if the patient is concurrently taking other medications that contain acetaminophen.

Before administering this product, it is advisable to consult a healthcare professional if the patient has a history of liver disease. In cases of overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought, or the Poison Control Center should be contacted. Prompt medical attention is critical, even if the patient does not exhibit any signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately. Healthcare professionals should advise patients to contact a Poison Control Center without delay at 1-800-222-1222.

Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms of overdose. Early intervention can significantly impact the management and outcome of potential liver injury.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been noted in patients taking acetaminophen, particularly among those with underlying liver disease or those who exceed the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been documented following the administration of acetaminophen. Furthermore, there have been reports of renal impairment linked to the use of acetaminophen, especially in patients with pre-existing kidney conditions.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage of this medication, as taking more than the prescribed amount may lead to liver damage. In the event of an overdose, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, emphasizing that prompt medical attention is crucial even if no symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a healthcare professional.

It is essential to inform patients that this product should not be used if their child has a history of allergic reactions to it or any of its components. Additionally, patients should be instructed to discontinue use and consult a healthcare provider 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.

While using this product, patients must not exceed the recommended dosage. Healthcare providers should also advise patients to consult a doctor before use if their child has liver disease or is currently taking the anticoagulant 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

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 counsel 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, even if no symptoms are apparent, as prompt medical attention is crucial.

Drug Information (PDF)

This file contains official product information for Good Sense Pain Reliefchildrens, 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 Sense Pain Reliefchildrens, 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.