Acetaminophen

Description

Acetaminophen Extended-Release Tablets USP are formulated to provide pain relief and reduce fever. Each tablet contains 650 mg of acetaminophen. The product is presented in a dosage form of gelatin-coated tablets, with a total of 80 geltabs per container.

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 advised to take 2 geltabs every 8 hours, ensuring that only one geltab is swallowed at a time. Prior to swallowing each geltab, it is recommended to take a sip of water, and each geltab should be washed down with water, up to a full 8 oz. glass. Geltabs must be swallowed whole and should 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 essential 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 in swallowing.

• 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

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 geltabs within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions 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 doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, it is crucial to obtain 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 in the absence of noticeable signs or symptoms.

When to Stop Use and Contact a Doctor Patients should discontinue use 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, redness or swelling is observed, or if the tablet becomes lodged in the throat. 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 6 geltabs within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume 3 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who have difficulty swallowing large tablets or capsules, particularly those over the age of 65, should avoid this product. Additionally, individuals with a known allergy to acetaminophen or any of the inactive ingredients should refrain from use.

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

Patients are instructed to stop using the product and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, if redness or swelling occurs, or if the tablet becomes lodged in the throat, as these may indicate a serious condition.

In the event of an overdose, it is crucial to seek 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.

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 before use. In the event of an overdose, prompt medical attention is essential for both children and adults, even if no signs or symptoms are apparent. It is important to keep this medication out of reach of children to prevent accidental ingestion.

Geriatric Use

Elderly patients, particularly those aged 65 and older, may experience difficulty swallowing the tablets. It is important for healthcare providers to consider this when prescribing the medication to geriatric patients, as alternative formulations may be necessary to ensure proper administration.

Additionally, it is advised that elderly patients consult a healthcare professional prior to use if they have a history of liver disease. This precaution is essential due to the potential for altered drug metabolism and increased risk of adverse effects in this population.

Furthermore, geriatric patients who are concurrently taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before initiating treatment with this medication. The interaction between these drugs may necessitate careful monitoring and possible dose adjustments to mitigate the risk of bleeding complications.

Overall, close attention to these considerations is crucial for the safe and effective use of this medication in elderly patients.

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 lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 daily dosage of 6 geltabs 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 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 lack of immediate symptoms does not preclude the potential for serious adverse effects. 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 rare cases of severe skin reactions associated with acetaminophen. Reported symptoms include skin reddening, blisters, and rash. In instances of skin reactions, it is advised that patients discontinue use and seek medical assistance immediately.

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 a doctor or pharmacist for clarification.

It is important to discuss with patients that they should not use this medication if they have difficulty swallowing large tablets or capsules, as this may pose a risk, particularly for individuals over the age of 65. Additionally, patients should be cautioned against using 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 stop using the medication and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever increases or lasts longer than 3 days. They should also be advised to consult a doctor if they experience new symptoms, or if they notice any redness or swelling. Furthermore, patients should be informed that if a tablet becomes lodged in their throat, they should stop use and seek medical attention, as this could indicate a serious condition.

Healthcare providers should recommend that patients with liver disease consult a doctor before using this medication. Additionally, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a container that is tamper evident. It is essential to inspect the bottle before use; do not use if the imprinted seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20 to 25° C (68 to 77° F). It is important to avoid exposure to high humidity to ensure the integrity of the product.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with the recommended dosage for adults being 2 geltabs every 8 hours. Each geltab must be swallowed whole, without crushing, chewing, splitting, or dissolving, and should be taken with a sip of water before swallowing, followed by a full glass of water. Patients should not exceed 6 geltabs in a 24-hour period and should not use the medication for more than 10 days unless directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional prior to use. 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 the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

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)