Acetaminophen

Description

Acetaminophen Extended-release Tablets USP are formulated for the temporary relief of minor arthritis pain. Each tablet contains 650 mg of acetaminophen, serving as a pain reliever and fever reducer. The product is presented in a capsule-shaped tablet form, with a total of 100 caplets per container. The National Drug Code (NDC) for this product is 62011-0026-1. It is designed to provide relief that lasts up to 8 hours. Caution is advised, as this product should not be used in conjunction with other medications containing acetaminophen. This formulation is comparable to the active ingredient found in Tylenol® Arthritis Pain and is marketed under the Health Mart® label. Use only as directed.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, and toothache. 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 caplets every 8 hours with water. The caplets should be swallowed whole and must not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 caplets 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 recommended to consult a doctor prior to use.

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.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 caplets within a 24-hour period, using it concurrently with other medications that contain acetaminophen, or consuming 3 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.

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

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six caplets within a 24-hour period, use the product in conjunction with other medications 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, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is recommended. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from use.

Patients should stop using the product and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts longer than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is also advised that patients consult a doctor prior to use if they have liver disease or are taking the anticoagulant medication warfarin, as these factors may influence the safety and efficacy of the product.

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. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. 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 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, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for these patients to consult a healthcare provider prior to use, especially if they have a history of liver disease. Additionally, geriatric patients who are concurrently taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before initiating treatment with this medication.

To ensure safety, elderly patients must adhere to the recommended dosage guidelines, which stipulate that no more than 6 caplets should be taken within a 24-hour period. Furthermore, the use of this medication should not exceed 10 days unless specifically directed by a healthcare professional. Close monitoring for any adverse effects is recommended in this population to mitigate potential risks associated with prolonged use or interactions with other medications.

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 the safety of both the mother and the developing fetus.

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 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 consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 6 caplets within a 24-hour period. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of liver injury.

Patients are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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 intervention 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, vigilance and timely action are essential in managing overdose situations effectively.

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. Reported symptoms of these reactions 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. 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 whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

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. The storage conditions require the product to be maintained at a temperature range of 20 to 25° C (68 to 77° F). It is essential to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F). For batch number and expiration date, please refer to the end panel of the packaging.

Additional Clinical Information

The medication is administered orally, with adults advised to take 2 caplets every 8 hours with water. Patients should swallow the caplets whole and must not crush, chew, split, or dissolve them. The maximum dosage is 6 caplets within a 24-hour period, and use should not exceed 10 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult 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, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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)