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Acetaminophen

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Active ingredient
Acetaminophen 500 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 2021
Label revision date
November 23, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 500 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 2021
Label revision date
November 23, 2021
Manufacturer
Allegiant Health
Registration number
M013
NDC root
69168-005
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 provides temporary relief from minor aches and pains, making it useful for a variety of common conditions. You might use it for discomfort associated with the common cold, headaches, toothaches, muscular aches, backaches, arthritis, menstrual cramps, and even to help reduce fever.

By targeting these types of pain, this medication can help you feel more comfortable and manage your symptoms effectively. Always remember to follow the guidance provided for its use to ensure you get the best results.

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 and older, you should take 2 caplets every 6 hours as long as your symptoms persist. However, it's important not to exceed 8 caplets in a 24-hour period unless your doctor advises otherwise. Additionally, you should not use this medication for more than 10 days unless directed by your healthcare provider.

For children under 12 years of age, it's essential to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

It's important to be cautious when using this medication. You should not take it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication includes acetaminophen, please consult your doctor or pharmacist for clarification.

Additionally, avoid using this product if you have a known allergy to acetaminophen or any of its inactive ingredients. Taking this medication under these circumstances could lead to serious health issues. Always prioritize your safety and well-being by following these guidelines.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. You should avoid using it if you are allergic to acetaminophen or any of its ingredients. Be cautious if you have liver disease, as taking more than 4,000 mg of acetaminophen in 24 hours can cause severe liver damage, especially if combined with other acetaminophen-containing products or if you consume three or more alcoholic drinks daily.

Watch for signs of severe skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the medication and seek medical help immediately. Additionally, if your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, you should consult a doctor. Always check with a healthcare professional if you are taking blood thinners like warfarin or if you have any concerns about your health while using this product.

Warnings and Precautions

It's important to be aware of some key warnings when using this product. It contains acetaminophen, which can cause severe liver damage if you take more than 4,000 mg in 24 hours, especially if you are also using other medications with acetaminophen or consuming three or more alcoholic drinks daily. Additionally, be cautious of potential severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If you experience any of these skin reactions, stop using the product and seek medical help immediately.

Before using this product, consult your doctor if you have liver disease or if you are taking the blood thinner warfarin. If you suspect an overdose, it's crucial to get emergency medical help or contact a Poison Control Center right away, even if you don't notice any symptoms. You should also stop taking the product and call your doctor if your pain worsens or lasts more than 10 days, if your fever gets worse or lasts more than 3 days, if you develop new symptoms, or if you notice any redness or swelling, as these could indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately 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. Quick action can make a significant difference, so don’t hesitate to get help if you think an overdose has occurred.

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 you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours as needed for symptoms, but be sure not to exceed 8 caplets in a 24-hour period unless directed by a doctor. Additionally, it's advised not to use the medication for more than 10 days without a doctor's guidance. Always prioritize your child's safety by following these recommendations closely.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep an open line of communication with your doctor about any changes in your health or any side effects you may experience.

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 you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. This limit includes the total amount from all medications containing acetaminophen, as well as if you consume three or more alcoholic drinks each day while using this product.

Before using this product, you should consult with your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.

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.

Additionally, you should avoid using this medication with 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 clarification. Always prioritize open communication about your medications to help prevent any harmful interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20º-25ºC (68º-77ºF). This temperature range helps maintain the product's integrity. Before using, always check that the safety seal under the cap is intact; do not use the product if this seal is broken or missing, as it may indicate that the product has been compromised.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep the medication out of reach of children. In the event of an 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 apparent.

If you experience any side effects, you can report them by calling 1-888-952-0050.

FAQ

What is the primary use of this drug?

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

What should adults and children 12 years and over do for dosage?

Adults and children 12 years and over should take 2 caplets every 6 hours while symptoms last, but should not exceed 8 caplets in 24 hours unless directed by a doctor.

What should I do if I have liver disease?

You should ask a doctor before using this product if you have liver disease.

Can I use this drug with other medications containing acetaminophen?

No, you should not use this drug with any other medication containing acetaminophen, whether prescription or nonprescription.

What are the signs of a severe skin reaction?

Severe skin reactions may include skin reddening, blisters, or rash. If you experience these symptoms, stop use and seek medical help immediately.

What should I do if my pain or fever worsens?

You should stop using the drug and call your doctor if your pain gets worse or lasts more than 10 days, or if your fever gets worse or lasts more than 3 days.

Is this drug safe to use during pregnancy 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 overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

What is the storage requirement for this drug?

You should store this drug between 20º-25ºC (68º-77ºF) and do not use it if the imprinted safety seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Pain Relief. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 aged 12 years and over are advised to take 2 caplets every 6 hours as needed for symptom relief. The maximum dosage should not exceed 8 caplets within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless specifically instructed by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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, this product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4000 mg of acetaminophen within a 24-hour period. This limit applies to the total intake from all sources, including other medications containing acetaminophen, as well as the consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to 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.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before using this product, as interactions may occur.

In cases of overdose, immediate medical attention is essential. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: worsening pain that persists beyond 10 days, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients who exceed a daily intake of 4000 mg of acetaminophen within a 24-hour period, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic beverages daily while using this product.

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

Acetaminophen should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should consult a healthcare professional. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from its use.

Patients with liver disease should consult a doctor prior to using this product. Furthermore, those taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before use.

Patients are advised to discontinue use and consult a doctor if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

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 and associated hepatotoxicity may be heightened. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed for symptom relief. It is important to note that this population should not exceed 8 caplets in a 24-hour period unless directed by a healthcare provider. Additionally, the use of this medication should not extend beyond 10 days unless specifically instructed by a doctor.

Geriatric Use

There is no specific information available 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 on the excretion of this drug in human 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 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 advised of the potential risks associated with the use of this product, particularly due to the presence of acetaminophen. Severe liver damage may occur if the maximum daily dosage of 4000 mg of acetaminophen is exceeded within a 24-hour period. This limit includes the total amount of acetaminophen from all sources, including other medications that may contain acetaminophen.

Additionally, patients should be cautioned against the consumption of three or more alcoholic drinks per day while using this product, as this may further increase the risk of liver damage.

It is recommended that patients with known liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations, as early recognition and treatment can significantly impact patient outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, 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.

No additional information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that side effects may be reported voluntarily by healthcare professionals and patients. Reports can be submitted to the designated contact number, 1-888-952-0050. This information is collected through various surveillance programs and voluntary reporting mechanisms.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help without delay.

It is crucial for patients to understand that quick medical attention is essential for both adults and children, even if they do not exhibit any noticeable signs or symptoms of overdose. Emphasizing this point can help ensure timely intervention and potentially mitigate serious health risks.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled temperature range of 20º-25ºC (68º-77ºF) to maintain its efficacy and safety.

Healthcare professionals should ensure that the product is not utilized if the imprinted safety seal under the cap is broken or missing, as this may indicate potential tampering or compromise of the product's integrity. Proper handling and adherence to these storage conditions are vital for ensuring the quality and safety of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Additionally, patients are encouraged to report any side effects experienced during the use of the medication by calling 1-888-952-0050.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Pain Relief, retrieved by a validated AI data-extraction workflow.

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

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

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

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

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

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