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Direct Safety Extra Strength Aspirin Free

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Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
September 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet, Film Coated
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 2013
Label revision date
September 9, 2025
Manufacturer
Conney Safety Products, LLC
Registration number
M013
NDC roots
61245-175, 61245-176
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Direct Safety® Extra Strength Aspirin-Free is a pain reliever and fever reducer that contains acetaminophen (a common medication used to alleviate pain and reduce fever) at a strength of 500 mg per tablet. It is designed to provide temporary relief from minor aches and pains, including headaches, muscular aches, minor arthritis pain, toothaches, menstrual cramps, and discomfort associated with the common cold. Additionally, it helps in reducing fever.

This product is available in an industrial pack containing 250 packets, each with two tablets, making it convenient for those who may need to manage pain or fever on a regular basis.

Uses

You can use this medication for the temporary relief of minor aches and pains. This includes discomfort from headaches, muscle aches, minor arthritis pain, toothaches, menstrual cramps, and even aches associated with the common cold. Additionally, it can help reduce fever, making you feel more comfortable when you're not feeling well.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 tablets every 4 to 6 hours as needed for relief. However, make sure not to exceed 8 tablets in a 24-hour period to avoid potential health risks.

For children under 12 years old, it’s important not to give this adult-strength product, as it contains a dosage that is too high for younger children. Giving them more than the recommended dose can lead to serious health issues, including liver damage. Always consult with a healthcare professional if you have questions about the appropriate medication for children.

What to Avoid

You should avoid using this medication alongside any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication includes acetaminophen, it's important to consult with your doctor or pharmacist.

Additionally, do not use this medication for more than 10 days to treat pain or more than 3 days for fever unless your doctor has specifically instructed you to do so. Following these guidelines helps ensure your safety and well-being.

Side Effects

Taking this medication can lead to some serious side effects, particularly concerning your liver. You should be cautious not to exceed 8 tablets in a 24-hour period, especially if you are also using other products containing acetaminophen or consuming three or more alcoholic drinks daily.

There is also a risk of severe skin reactions, which may present as skin reddening, blisters, or a rash. If you notice any of these symptoms, stop using the medication and seek medical help immediately. Additionally, if your symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens, you should consult a doctor. It's important to talk to your healthcare provider before using this medication if you have liver disease or are taking blood thinners like warfarin. In case of an accidental overdose, seek medical assistance right away, even if you don't see any immediate symptoms.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 8 tablets in 24 hours, use it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

Before using this medication, consult your doctor if you have liver disease or are taking the blood-thinning medication warfarin. If you accidentally take too much, get emergency medical help or contact a Poison Control Center right away, even if you don’t notice any symptoms. You should also stop using the product and call your doctor if your symptoms do not improve, if new symptoms appear, or if pain or fever persists or worsens.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Remember, prompt medical attention can make a significant difference, so don’t hesitate to reach out for help.

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

It's important to be cautious when giving medications to children. If your child is under 12 years old, you should not give them this adult-strength product. Doing so can lead to an overdose, which may harm their liver. Always ensure that any medication you provide is appropriate for your child's age and weight to keep them safe. If you have any questions about the right dosage for your child, consult your healthcare provider.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it's important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

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 should be used 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 you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not take more than 8 tablets in a 24-hour period, and be aware that this is the maximum daily amount. Additionally, avoid using other medications that also contain acetaminophen, and limit your alcohol intake to fewer than 3 drinks per day while using this product.

Before starting this medication, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using this product.

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 can increase your risk of bleeding, which can be serious.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potential interactions. This conversation is crucial for managing your health effectively.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally between 59ºF and 86ºF (15ºC and 30ºC). It's important to keep the product in its tamper-evident sealed packets, as using any opened or torn packets can compromise safety and effectiveness. Always check the packaging before use to ensure it is intact. By following these simple guidelines, you can help maintain the integrity of the product.

Additional Information

You should take 2 tablets every 4 to 6 hours as needed if you are an adult or a child aged 12 years and older. However, do not exceed 8 tablets in a 24-hour period. If the user is under 12 years old, this adult-strength product should not be given, as it could lead to an overdose and potentially cause liver damage.

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

FAQ

What is Direct Safety® Extra Strength Aspirin-Free used for?

It is a pain reliever and fever reducer used for temporary relief of minor aches and pains, including headaches, muscular aches, minor arthritis pain, common cold, toothaches, and menstrual cramps.

What is the active ingredient in this medication?

The active ingredient is acetaminophen, with a dosage of 500 mg per tablet.

What are the dosage instructions for adults and children over 12?

Adults and children 12 years and older should take 2 tablets every 4 to 6 hours as needed, not exceeding 8 tablets in 24 hours.

Can children under 12 take this medication?

No, this adult strength product should not be given to children under 12 years of age, as it may cause an overdose and liver damage.

What should I do if I experience a skin reaction?

If you notice symptoms like skin reddening, blisters, or rash, stop using the product and seek medical help immediately.

What are the liver warnings associated with this product?

Severe liver damage may occur if you take more than 8 tablets in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do in case of an accidental overdose?

Get medical help or contact a Poison Control Center right away, as prompt medical attention is critical for both adults and children.

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

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

What should I do if my symptoms do not improve?

Stop using the product and consult your doctor if symptoms do not improve, new symptoms occur, or if pain or fever persists or worsens.

How should I store this medication?

Store at room temperature between 59º-86ºF (15º-30ºC) and use tamper-evident sealed packets; do not use any opened or torn packets.

Packaging Info

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

Packaging configurations for Direct Safety Extra Strength Aspirin Free.
Details

Drug Information (PDF)

This file contains official product information for Direct Safety Extra Strength Aspirin Free, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, muscular aches, minor arthritis pain, common cold, toothache, 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 aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed. The maximum allowable dosage is 8 tablets within a 24-hour period.

For children under 12 years of age, this adult strength product is contraindicated. Administration to this age group may result in an overdose, which poses a risk of liver damage. It is essential to adhere strictly to these guidelines to ensure safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication 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.

Additionally, the product should not be used for pain relief for more than 10 days or for fever for more than 3 days unless directed by a physician. Prolonged use beyond these durations without medical supervision may lead to adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they exceed the maximum daily dosage of 8 tablets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic beverages daily while taking this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

Prior to recommending this product, healthcare providers should inquire about any existing liver disease in patients. Additionally, it is advisable to consult with a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin, as interactions may occur.

In cases of accidental overdose, it is imperative to seek emergency medical help or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no immediate signs or symptoms are apparent.

Patients should be instructed to stop using the product and consult a healthcare professional if symptoms do not improve, if new symptoms arise, if pain or fever persists or worsens, or if there is any redness or swelling.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 tablets within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to stop using the product and consult a healthcare professional if symptoms do not improve, new symptoms arise, pain or fever persists or worsens, or if redness or swelling is observed.

Individuals with liver disease should consult a doctor prior to using this product. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before use.

In cases of accidental overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication, as concurrent use may elevate the risk of bleeding.

No additional drug interactions or laboratory test interactions have been identified. Therefore, routine monitoring or dosage adjustments are not specified beyond the aforementioned consideration with warfarin.

Packaging & NDC

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

Packaging configurations for Direct Safety Extra Strength Aspirin Free.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this adult strength product, as it may result in doses exceeding the recommended levels, leading to potential overdose and associated risks, including liver damage. Caution is advised when considering treatment options for this age group to ensure safety and efficacy.

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.

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 currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients limit alcohol consumption to fewer than 3 drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

Patients with known liver disease should consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, vigilance and timely intervention are essential in managing potential overdosage scenarios effectively.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

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 keep this medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of safety in the home environment.

In the event of an accidental overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. They should be made aware that prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly mitigate potential health risks associated with overdose situations.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to avoid using any packets that are opened or torn.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 59ºF to 86ºF (15ºC to 30ºC). Proper adherence to these storage conditions is crucial to preserve the quality and efficacy of the product.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed, with a maximum of 8 tablets in a 24-hour period. For children under 12 years, this adult strength product should not be administered, as it may lead to an overdose and potential liver damage.

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 medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Drug Information (PDF)

This file contains official product information for Direct Safety Extra Strength Aspirin Free, 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 Direct Safety Extra Strength Aspirin Free, 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.