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Non-Aspirin

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This product has been discontinued

Active ingredient
Acetaminophen 325 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
December 30, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 325 mg
Other brand names
Dosage form
Tablet
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 2010
Label revision date
December 30, 2017
Manufacturer
Genuine First Aid LLC
Registration number
part343
NDC root
52124-0010
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

This medication, distributed by GENUINE FIRST AID, is designed to provide temporary relief from minor aches and pains. It can help with discomfort associated with common conditions such as the cold, headaches, toothaches, muscular aches, backaches, arthritis, menstrual cramps, and it also aids in reducing fever. Notably, this product is labeled as "Non Aspirin," making it a suitable option for those who may need to avoid aspirin for various reasons.

By targeting these common ailments, this medication aims to improve your comfort and well-being during times of discomfort. Always consult with a healthcare professional if you have questions about its use or suitability for your specific needs.

Uses

You can use this medication for the temporary relief of minor aches and pains that may arise from various conditions. This includes discomfort associated with the common cold, headaches, toothaches, muscular aches, backaches, arthritis, and menstrual cramps. Additionally, it can help reduce fever.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. Always consult with a healthcare professional if you have any questions or concerns about its use.

Dosage and Administration

If you are an adult or a child aged 12 years or older, you can take 2 tablets every 4 to 6 hours as needed for relief. However, make sure not to exceed 12 tablets in a 24-hour period to avoid any potential risks.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in a 24-hour period. It's important to note that this regular strength product should not be used for children under 6 years of age. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to be cautious when using this medication. You should never use it alongside any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. Additionally, avoid using any packets that are open or torn, and make sure not to exceed the recommended dosage.

For pain relief, do not use this medication for more than 10 days unless your doctor advises otherwise. If you're using it to reduce fever, limit your use to no more than 3 days unless directed by a healthcare professional. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if not used carefully. You should avoid taking more than 12 tablets in 24 hours if you are an adult, or more than 5 doses if you are a child. Be cautious if you consume three or more alcoholic drinks daily while using this product, or if you are taking other medications that also contain acetaminophen.

It's important to stop using this product and consult a doctor if your symptoms do not improve, if your pain worsens or lasts longer than 10 days, if your fever gets worse or lasts more than 3 days, or if you notice any new symptoms, redness, or swelling. Additionally, if you have liver disease or are taking the blood-thinning medication warfarin, please consult a doctor or pharmacist before use.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if not used carefully. You should not take more than 12 tablets in 24 hours if you are an adult, or more than 5 doses in 24 hours if you are a child. Be cautious if you are taking other medications with acetaminophen or if you consume 3 or more alcoholic drinks daily while using this product.

Always check the packaging for tamper-evident seals and do not use any packets that are open or torn. If you have liver disease, consult your doctor before using this product. In case of an accidental overdose, seek emergency medical help immediately, even if you do not notice any symptoms.

You should stop using this product and call your doctor if your symptoms do not improve, if your pain worsens or lasts longer than 10 days, if your fever worsens or lasts more than 3 days, if you develop new symptoms, if you notice redness or swelling, or if you experience a rare sensitivity reaction.

Overdose

Taking too much of a product that contains acetaminophen can lead to serious health issues, particularly liver damage. You should be aware that adults should not take more than 12 tablets in a 24-hour period, while children should not take more than 5 doses in the same timeframe. Additionally, combining this product with other medications that also contain acetaminophen or consuming 3 or more alcoholic drinks daily while using it can increase the risk of severe liver damage.

If you suspect an overdose, look for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). It’s crucial to seek immediate medical help if you experience any of these symptoms or if you believe you have taken too much of the medication. Always prioritize your health and safety by following the recommended dosage guidelines.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is between 6 and 11 years old, they can take 1 tablet every 4 to 6 hours as needed, but make sure they do not exceed 5 tablets in a 24-hour period. It's important to follow this guideline to ensure their safety and well-being.

For children under 6 years of age, you should avoid using this regular strength product. Giving it to younger children can lead to an overdose, which may result in serious health issues. Always consult with a healthcare professional if you have any questions about medication for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

This product contains acetaminophen, which can be harmful to your liver, especially if you have liver problems. It's important to be aware that severe liver damage can occur if you exceed certain limits. For adults, taking more than 12 tablets in a 24-hour period is the maximum safe amount. For children, the limit is more than 5 doses in the same timeframe. Additionally, combining this product with other medications that also contain acetaminophen or consuming 3 or more alcoholic drinks daily while using it can increase the risk of liver damage.

If you have liver conditions, please consult your healthcare provider before using this product to ensure it is safe for you. They may recommend monitoring your liver function or adjusting your dosage to prevent any potential harm.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, so your healthcare provider can help ensure your safety by managing your treatment plan effectively. Always keep an open line of communication about all the medications you are taking to avoid any potential interactions.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 59-86°F (15-30°C). This temperature range helps maintain the integrity of the device and its components.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

For adults and children aged 12 and older, you should take 2 tablets every 4 to 6 hours as needed, but do not exceed 12 tablets in a 24-hour period. For children aged 6 to 11, the recommended dose is 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in 24 hours. This product is not recommended for children under 6 years of age.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Always keep it out of reach of children, and in case of accidental overdose, contact a doctor or Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are present.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of minor aches and pains associated with conditions like the common cold, headache, toothache, muscular aches, backache, arthritis, menstrual cramps, and it also helps reduce fever.

What should adults and children 12 years or older take?

Adults and children 12 years of age or older should take 2 tablets every 4 to 6 hours as needed, not exceeding 12 tablets in 24 hours.

What is the dosage for children aged 6-11 years?

Children aged 6-11 years should take 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in 24 hours.

Can children under 6 years of age use this product?

No, children under 6 years of age should not use this regular strength product.

What are the warnings associated with this drug?

This product contains acetaminophen, and severe liver damage may occur if the maximum dosage is exceeded or if taken with other acetaminophen-containing drugs.

What should I do if symptoms do not improve?

You should stop using the drug and consult a doctor if symptoms do not improve, if pain lasts more than 10 days, or if fever lasts more than 3 days.

Is it safe to use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this drug.

What should I do in case of an accidental overdose?

In case of accidental overdose, contact a doctor or Poison Control Center immediately, as prompt medical attention is critical.

Are there any contraindications for this drug?

You should not use this drug with any other product containing acetaminophen, whether prescription or nonprescription.

How should this drug be stored?

Store this drug at a temperature between 59-86 degrees F (15-30 degrees C).

Packaging Info

Below are the non-prescription pack sizes of Non-Aspirin (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Non-Aspirin.
Details

Drug Information (PDF)

This file contains official product information for Non-Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Distributed by GENUINE FIRST AID, located at 600 Cleveland Str Suite 400, Clearwater, FL 33755.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, toothache, muscular aches, backache, arthritis, and menstrual cramps. Additionally, it is indicated for the reduction of fever.

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

Dosage and Administration

Adults and children 12 years of age or older are instructed to take 2 tablets every 4 to 6 hours as needed. The maximum allowable dosage is 12 tablets within a 24-hour period.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum limit of 5 tablets in a 24-hour period.

This product is not recommended for use in children under 6 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

Additionally, the product must not be used if the packaging is open or torn. It is also contraindicated to exceed the recommended dosage. The product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. It is critical to adhere to the following guidelines to minimize the risk of liver injury. Adults should not exceed 12 tablets within a 24-hour period, which is the maximum daily dosage. For children, the maximum is 5 doses in 24 hours. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage.

General precautions include the use of tamper-evident sealed packets. Users should not utilize any packets that are open or torn, as this may compromise the safety and efficacy of the product.

Before initiating use, it is advisable for individuals with liver disease to consult a healthcare professional. This precaution is essential to ensure safe usage and to determine appropriate monitoring parameters.

In the event of an accidental overdose, immediate medical assistance should be sought. Users are urged to contact a doctor or the Poison Control Center without delay, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Users should discontinue use and consult a healthcare provider if any of the following occur: symptoms do not improve, pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms arise, redness or swelling is observed, or a rare sensitivity reaction occurs. These actions are vital to ensure the safety and well-being of the user.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly concerning liver health. The product contains acetaminophen, and severe liver damage may occur under certain conditions. Specifically, adults should not exceed 12 tablets in a 24-hour period, while children should not take more than 5 doses within the same timeframe. The risk of liver damage is heightened if the product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

In clinical practice, patients are advised to stop use and consult a healthcare professional if symptoms do not improve, if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, if redness or swelling occurs, or if a rare sensitivity reaction is experienced.

Additionally, it is recommended that patients seek medical advice prior to using this product if they have a history of liver disease or if they are concurrently taking the blood-thinning medication warfarin. These precautions are essential to ensure patient safety and to mitigate the risk of adverse reactions.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional prior to using this product. The interaction between this product and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Non-Aspirin (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Non-Aspirin.
Details

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in a 24-hour period. For children under 6 years of age, the regular strength product is not recommended due to the risk of overdose, which could lead to serious health problems.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if the maximum daily dosage is exceeded. Specifically, adults should not take more than 12 tablets in a 24-hour period, while children should not exceed 5 doses within the same timeframe.

Additionally, patients with compromised liver function should be advised against the concurrent use of other medications containing acetaminophen, as this may increase the risk of liver damage. Furthermore, adults who consume three or more alcoholic drinks daily while using this product are at an elevated risk for severe liver injury.

It is essential for healthcare providers to assess liver function and consider these factors when prescribing this product to patients with hepatic impairment. Regular monitoring of liver function tests may be warranted to ensure patient safety.

Overdosage

Severe liver damage may occur with acetaminophen overdosage. It is crucial for healthcare professionals to be aware of the specific circumstances that can lead to such adverse effects.

Liver Warning This product contains acetaminophen, which is associated with the risk of liver damage when dosed improperly.

Risk Factors for Overdosage The following conditions significantly increase the risk of severe liver damage:

  • An adult consuming more than 12 tablets within a 24-hour period, which is the maximum recommended daily dosage.

  • A child taking more than 5 doses within a 24-hour period.

  • Concurrent use of other medications that also contain acetaminophen.

  • An adult who consumes 3 or more alcoholic beverages daily while using this product.

Recommended Actions In the event of suspected overdosage, immediate medical attention is advised. Healthcare professionals should assess the patient's condition and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are essential components of management.

Prompt recognition and intervention are critical to mitigate the risk of severe liver damage associated with acetaminophen overdosage.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, it is crucial for patients to contact a doctor or the Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. Additionally, healthcare providers should emphasize the importance of adhering to the recommended dosage and caution patients against exceeding it.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 59 to 86 degrees Fahrenheit (15 to 30 degrees Celsius) to ensure its stability and efficacy. Proper container requirements must be adhered to, and special handling needs should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed, with a maximum of 12 tablets in a 24-hour period. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, not exceeding 5 tablets in 24 hours. This product is not recommended for children under 6 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is essential to keep the medication out of reach of children. In the event of an accidental overdose, immediate contact with a doctor or Poison Control Center is crucial, as prompt medical attention is necessary for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Non-Aspirin, 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 Non-Aspirin, 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

Last AI update:

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.