Acetaminophen

Description

equate® is an extended-release formulation of acetaminophen, classified as a pain reliever and fever reducer, indicated for the temporary relief of minor arthritis pain. Each gelatin-coated tablet contains 650 mg of acetaminophen, with a total package size of 20 geltabs. The product is designed to provide relief lasting up to 8 hours. It is important to note that equate® should not be used in conjunction with other medications containing acetaminophen. The product is distributed by Wal-Mart Stores, Inc. The National Drug Code (NDC) for equate® is 49035-350-20.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including muscular aches, backache, headache, toothache, the common cold, 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 are instructed to take 2 geltabs every 8 hours, ensuring that only one geltab is swallowed at a time. Prior to swallowing each geltab, a sip of water should be taken, and the geltab should be washed down with water, up to a full 8 oz. glass. It is essential to swallow the geltabs whole; they must not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 geltabs within a 24-hour period. Additionally, the use of this medication should not extend beyond 10 days unless directed by a healthcare professional.

For individuals under 18 years of age, it is advised to consult a doctor before use.

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.

• Patients with difficulty swallowing large tablets or capsules should not use this product, as it may pose a risk of choking. This is particularly relevant for individuals over the age of 65, who may experience increased difficulty.

• Individuals with a known allergy to acetaminophen or any of the inactive ingredients in this formulation should avoid use to prevent allergic reactions.

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 the maximum daily dosage of 6 geltabs within a 24-hour period, use this product concurrently with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while taking this product.

Patients with a history of liver disease should be cautioned to consult a physician prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before using this product, as potential interactions may occur.

In the event of an overdose, it is imperative to seek emergency medical assistance 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 symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: worsening pain or pain lasting more than 10 days; fever that worsens or persists for more than 3 days; the emergence of new symptoms; the presence of redness or swelling; or if the tablet becomes lodged in the throat. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 6 geltabs within a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients are advised not to use this product if they are currently taking any other drug that contains acetaminophen, whether prescription or nonprescription. Additionally, individuals who have difficulty swallowing large tablets or capsules, particularly those over the age of 65, should avoid this product. It is also contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients present in the formulation.

Before using this product, patients should consult a healthcare professional if they have liver disease or are taking the anticoagulant medication warfarin, as these conditions may increase the risk of adverse effects.

Patients should discontinue use and seek medical advice if they experience worsening pain that lasts more than 10 days, a fever that persists for more than 3 days, the emergence of new symptoms, the presence of redness or swelling, or if the tablet becomes lodged in the throat. These symptoms may indicate a serious underlying condition.

In the event of an overdose, it is critical for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are initially apparent.

Drug Interactions

The concomitant use of acetaminophen and warfarin may elevate the risk of bleeding due to potential pharmacodynamic interactions. It is advisable to monitor patients closely for signs of increased bleeding and to consider adjusting the dosage of warfarin as necessary based on the patient's clinical response and INR levels. Regular monitoring of coagulation parameters is recommended to ensure patient safety.

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 18 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this population.

Geriatric Use

Elderly patients, particularly those aged 65 and older, may experience difficulty swallowing the tablets. This consideration is important when prescribing this medication, as it may impact adherence to the treatment regimen. Healthcare providers should assess the ability of geriatric patients to swallow the tablets and consider alternative formulations or methods of administration if necessary to ensure effective treatment and patient compliance.

Pregnancy

Pregnant patients 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 are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure appropriate management during pregnancy.

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

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

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 the maximum daily dosage of 6 geltabs within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Prior to use, patients with known liver disease are advised to consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects related to hepatic impairment.

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 depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose 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.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been documented, with some cases necessitating liver transplantation, particularly among patients who exceed the recommended dosage or use acetaminophen in conjunction with other medications containing the same active ingredient. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been observations of renal impairment and acute kidney injury linked to acetaminophen use, especially in patients with pre-existing renal conditions or those consuming high doses.

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 at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a container that is tamper evident; it should not be used if the imprinted seal is broken or missing. It is essential to store the product at a temperature range of 20 to 25° C (68 to 77° F) and to avoid exposure to high humidity to maintain its integrity and effectiveness. Proper handling and storage conditions are crucial to ensure the product remains safe for use.

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 at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or 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)