Acetaminophen

Description

Acetaminophen Caplets are extended-release tablets containing 650 mg of acetaminophen, designed for the temporary relief of minor arthritis pain. Each blister carton contains 24 capsule-shaped tablets, with a dosage form that allows for pain relief lasting up to 8 hours. These caplets are comparable to the active ingredient found in TYLENOL® ARTHRITIS PAIN. The product is distributed by Select Brand Distributors.

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, headache, toothache, the common cold, 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 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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Patients who have difficulty swallowing large tablets or capsules should not use this product. This is particularly relevant for individuals over the age of 65, who may experience increased difficulty in swallowing.

• The product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained within this 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 the maximum daily dosage of 6 caplets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Patients with 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 in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 caplets within 24 hours, use it concurrently with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should not use this product if they are taking any other drug containing acetaminophen, whether prescription or nonprescription. It is advised to consult a doctor or pharmacist if there is uncertainty regarding the presence of acetaminophen in other medications. Additionally, individuals who have difficulty swallowing large tablets or capsules, particularly those over 65 years of age, should avoid this product. It is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation.

Patients with liver disease should seek medical advice before using this product. Furthermore, those taking the blood-thinning medication warfarin are advised to consult a healthcare professional prior to use.

Patients are instructed to discontinue use and consult a doctor if pain worsens or persists for more than 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious 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 are immediately 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 before use. In cases of overdose, it is crucial to seek immediate medical attention for both children and adults, even if no signs or symptoms are apparent.

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 dosage forms if necessary to ensure effective administration and patient compliance. Monitoring for any swallowing difficulties or related complications is advised in this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes 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 should consult a healthcare professional prior to use, particularly if they have liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment. Careful evaluation is necessary to ensure safe and effective use in this population.

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 caplets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this can 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 strongly discouraged, 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 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 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 these contexts.

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 resulting in liver transplantation, particularly among patients with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been cases of renal impairment and acute kidney injury linked to the use of acetaminophen, especially in patients with pre-existing kidney conditions or those taking high doses.

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 medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

It is important to caution patients against using this medication if they have difficulty swallowing large tablets or capsules, particularly individuals over the age of 65, who may experience such difficulties.

Patients should be made aware that they must not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients included in the product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, patients should be advised to 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.

Additionally, patients should be encouraged to consult a doctor before using this medication if they have liver disease. It is also advisable for patients to speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin.

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 from the bottle.

For optimal storage, the product must be kept 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). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with adults advised to take 2 caplets every 8 hours with water, swallowing them whole without crushing, chewing, splitting, or dissolving. The maximum dosage is 6 caplets within a 24-hour period, and it should not be used for more than 10 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor before use if they have liver disease or are taking the blood-thinning medication warfarin. Pregnant or breastfeeding patients should seek advice from 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 must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, regardless of the presence of 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)