Acetaminophen Extended-Release

Description

No relevant information is available for SPL code 34089-3.

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, this drug 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 drugs 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

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 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 drinks daily while taking this product.

Patients should be alerted to the potential for severe skin reactions associated with acetaminophen. Symptoms such as skin reddening, blisters, or rash may indicate an allergic reaction. In the event of any skin reaction, patients must 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, those taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as interactions may occur.

In cases of overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is vital for both adults and children.

Patients should discontinue use and consult a healthcare professional if they experience worsening pain lasting more than 10 days, a fever that persists or worsens beyond 3 days, the emergence of new symptoms, or any signs of 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 potential adverse reactions, particularly those related to liver health and allergic responses.

Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. Patients with pre-existing liver disease should consult a healthcare professional before use.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. 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 contained within. It is also recommended that patients consult a doctor or pharmacist before use if they are currently taking the blood-thinning medication warfarin.

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

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. Patients are advised to verify the presence of acetaminophen in other medications with a healthcare provider or pharmacist to avoid unintentional overdose and associated adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen Extended-Release (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 consult a healthcare provider prior to using this medication, particularly if they have liver disease, as this may affect the drug's metabolism and safety profile. Additionally, it is important for geriatric patients to inform their doctor or pharmacist if they are concurrently taking warfarin, a blood-thinning medication, due to potential interactions that could increase the risk of bleeding.

Furthermore, elderly patients are advised not to use this medication for more than 10 days unless specifically directed by a healthcare professional. Prolonged use without medical supervision may lead to adverse effects or complications, necessitating careful monitoring and evaluation by a healthcare provider.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, it is recommended that patients limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product to mitigate 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.

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 compound in these areas.

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 about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical intervention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients must be cautioned against using 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 other medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

It is essential to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients included in the formulation.

Patients should be instructed to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, they should seek medical advice if their fever intensifies or lasts longer than 3 days. Patients should also be advised to stop using the product and contact a healthcare professional if they experience new symptoms or notice any redness or swelling, as these may indicate a serious condition.

Additionally, patients with liver disease should be encouraged to consult a doctor before using this product. Those taking the blood-thinning medication warfarin should also 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

The medication is administered orally. For adults, the recommended dosage is 2 caplets every 8 hours, taken with water, and they should be swallowed whole without crushing, chewing, splitting, or dissolving. Patients should not exceed 6 caplets in a 24-hour period and should not use the medication for more than 10 days unless directed by a healthcare professional. For individuals under 18 years of age, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)