Acetaminophen

Description

NDC 49035-531-12. This product, equate™, is formulated to compare to the active ingredient in Extra Strength Tylenol®. Each coated tablet contains 500 mg of acetaminophen, serving as a pain reliever and fever reducer. The product is presented in a bottle containing 100 tablets and is free from aspirin. It is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. Distributed by Walmart Inc., Bentonville, AR 72716, this product is manufactured in China. It is important to note that this product is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Extra Strength Tylenol®.

Uses and Indications

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

For children under 12 years of age, it is recommended to consult a healthcare professional before administration.

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. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

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 significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as there may be potential interactions.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present, as prompt intervention is vital for both adults and children.

Patients should also be instructed to stop taking the product and consult a healthcare professional if new symptoms arise, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients with pre-existing liver disease should consult a healthcare professional before use.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. It is also contraindicated for use with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should consult a doctor or pharmacist.

Patients taking the blood-thinning medication warfarin should seek advice from a healthcare professional prior to using this product.

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

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 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 Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

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 tablets every 6 hours as needed for symptom relief, with a maximum of 6 tablets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare provider.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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 attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate interventions as necessary.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include blisters, rash, and skin reddening. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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

It is important to instruct patients to avoid using this product if they have a known allergy to acetaminophen or any of the inactive ingredients included in the formulation.

Patients should be counseled to discontinue use and consult a doctor if they experience new symptoms, if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days. Additionally, they should be advised to seek medical advice if they notice any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult a doctor before using this medication if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted between 15°C and 30°C (59°F and 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours while symptoms persist, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a physician. It is advised not to use the medication for more than 10 days without medical guidance. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to consult a healthcare 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 contact a Poison Control Center, as prompt attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)