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Walgreens Pain Reliever

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Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2009
Label revision date
September 4, 2025
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
Marketed in the U.S.
Since 2009
Label revision date
September 4, 2025
Manufacturer
Sixarp, LLC
Registration number
M013
NDC root
59368-232

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Drug Overview

Acetaminophen is a widely used pain reliever and fever reducer, commonly available in 500 mg caplets. It is effective for temporarily relieving minor aches and pains associated with various conditions, including the common cold, headaches, arthritis, backaches, muscular aches, toothaches, and menstrual cramps. Additionally, it helps to reduce fever.

This extra-strength formulation is designed for adults and is free from artificial flavors, synthetic colors, gluten, and genetically modified organisms (non-GMO), making it a suitable option for those looking for a pure product.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including the common cold, headaches, arthritis, backaches, muscular aches, toothaches, and menstrual cramps. It can also help reduce fever, providing you with some comfort when you're not feeling well.

This medication is designed to address these common discomforts, making it a helpful option for managing everyday pain and fever.

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 you have symptoms. However, make sure not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. It's also important to limit your use to no more than 10 days unless directed by a healthcare professional.

For children under 12 years old, it's best 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

You should avoid using this product if you have ever had an allergic reaction to it or any of its ingredients. Additionally, do not take this product alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with a doctor or pharmacist for clarification. Taking these precautions will help ensure your safety and well-being.

Side Effects

Taking this product may lead to some serious side effects, particularly related to liver health. It's important to avoid exceeding 4,000 mg of acetaminophen in a 24-hour period, using it alongside other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product, as these actions can significantly increase the risk of severe liver damage.

You should also be aware of potential allergic reactions, which can manifest as severe skin issues, including redness, blisters, or rashes. If you experience any of these symptoms, stop using the product immediately and seek medical assistance. Additionally, if you have liver disease or are taking blood thinners like warfarin, consult your doctor before using this product. If your pain or fever worsens or lasts longer than expected, or if you notice new symptoms, it's crucial to stop use and contact a healthcare professional, as these could indicate a more serious condition. In case of overdose, seek medical help right away.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any skin reactions, stop using the product and seek medical help immediately.

Before using this product, consult your doctor if you have liver disease or are taking the blood thinner warfarin. If you suspect an overdose, get emergency medical help or contact a Poison Control Center right away at 1-800-222-1222, as prompt attention is crucial. Additionally, stop using the product and call your doctor if your pain worsens or lasts more than 10 days, your fever worsens or lasts more than 3 days, you develop new symptoms, or if you notice redness or swelling, as these may indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action 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. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you have any concerns about an overdose.

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 have a child under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours while symptoms persist, but you should not exceed 6 caplets in a 24-hour period unless directed by a doctor.

Keep in mind that this medication should not be used for more than 10 days unless a doctor advises otherwise. Additionally, be aware that in case of an overdose, seeking quick medical attention is crucial for both adults and children, even if there are no immediate signs or symptoms.

Geriatric Use

If you are an older adult or caring for one, it's important to consult a doctor before using this medication, especially if there is a history of liver disease. For adults and children aged 12 and older, the recommended dosage is 2 caplets every 6 hours as needed for symptoms, but you should not exceed 6 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 a healthcare professional. If you are considering this medication for a child under 12, please consult a doctor first. Always prioritize safety and seek guidance from a healthcare provider when it comes to medication use in older adults.

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 determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver disease, it’s important to consult your doctor before using this medication. Your healthcare provider can help determine if it’s safe for you and whether any adjustments to your dosage are necessary. Monitoring your liver function is crucial to ensure your safety while taking this medication. Always prioritize open communication with your doctor regarding your liver health.

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 of your product, store it at a temperature between 20-25ºC (68-77ºF). This temperature range helps maintain its effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and compliance.

Additional Information

You should take 2 caplets every 6 hours while symptoms last, but do not exceed 6 caplets in a 24-hour period unless directed by a doctor. This medication should not be used for more than 10 days without a doctor's guidance. If you are under 12 years old, consult a doctor before use.

If you are pregnant or breastfeeding, it's important to ask a health professional before using this medication. Always keep it out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are present.

FAQ

What is Acetaminophen used for?

Acetaminophen is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to conditions like the common cold, headache, arthritis, backache, muscular aches, toothache, and menstrual cramps.

What is the recommended dosage for adults and children 12 years and older?

You should take 2 caplets every 6 hours while symptoms last, but do not exceed 6 caplets in 24 hours unless directed by a doctor.

Are there any warnings associated with Acetaminophen?

Yes, severe liver damage may occur if you take more than 4,000 mg in 24 hours, use it with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it.

What should I do if I experience a skin reaction?

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

Can I use Acetaminophen if I have liver disease?

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

What should I do in case of an overdose?

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

Is Acetaminophen safe to use during pregnancy or breastfeeding?

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

What should I do if my symptoms do not improve?

Stop using Acetaminophen and consult a doctor if your pain worsens or lasts more than 10 days, or if your fever lasts more than 3 days.

Can children under 12 years use Acetaminophen?

Children under 12 years should ask a doctor before using Acetaminophen.

Packaging Info

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

Packaging configurations for Walgreens Pain Reliever.
Details

Drug Information (PDF)

This file contains official product information for Walgreens Pain Reliever, 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 specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, minor pain of arthritis, backache, muscular aches, toothache, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary 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 instructed to take 2 caplets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days unless specifically advised 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, 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.

  • History of allergic reaction to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the risk of liver damage increases with the following conditions:

  • Consumption of more than 4,000 mg of acetaminophen within a 24-hour period.

  • Concurrent use with other medications that contain acetaminophen.

  • Daily intake of three or more alcoholic beverages while using this product.

Additionally, there is an allergy alert associated with acetaminophen. Patients may experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

General precautions should be taken into account prior to use. Patients with a history of liver disease should consult a healthcare provider before using this product. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as interactions may occur.

In cases of overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be advised to stop taking the product and consult a healthcare professional if any of the following occur:

  • Pain worsens or persists for more than 10 days.

  • Fever intensifies or lasts longer than 3 days.

  • New symptoms develop.

  • Redness or swelling is observed.

These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume three 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, patients are advised to discontinue use immediately and seek medical assistance.

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Additionally, individuals with liver disease should consult a doctor prior to use. Those taking the blood-thinning medication warfarin are also encouraged to seek advice from a healthcare professional before using this product.

Patients should 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.

In the case of an overdose, it is imperative for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. 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 Walgreens Pain Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Walgreens Pain Reliever.
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, with a maximum of 6 caplets in a 24-hour period, unless otherwise directed by a physician. It is important to note that the medication should not be used for more than 10 days without medical advice.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed for symptom relief, with a maximum of 6 caplets in a 24-hour period, unless otherwise directed by a physician.

It is important to note that the use of this medication should not exceed 10 days unless specifically instructed by a healthcare professional. For children under 12 years of age, a consultation with a doctor is advised before administration.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, particularly those with pre-existing liver conditions, and monitor for any adverse effects or the need for dosage adjustments.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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. Regular monitoring of renal function may be advisable in these patients, although specific guidelines are not outlined.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the pharmacokinetics and safety profile of the drug. Monitoring of liver function may be necessary to ensure safe and effective use in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

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

It is important to instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, they should stop use and seek medical advice if their fever worsens or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, healthcare providers should recommend that patients with liver disease consult a doctor prior to using this product. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25ºC (68-77ºF) to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any conditions that may compromise the quality of the product.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 caplets every 6 hours as needed for symptom relief, with a maximum of 6 caplets in a 24-hour period unless otherwise directed by a healthcare professional. Use should not exceed 10 days without medical guidance. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

This file contains official product information for Walgreens Pain Reliever, 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 Walgreens Pain Reliever, retrieved by a validated AI data-extraction workflow.

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

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

No human clinician has reviewed this version.

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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.