Acetaminophen

Description

Acetaminophen is an extended-release formulation available in tablet form, with each tablet containing 650 mg of the active ingredient. This medication serves as a pain reliever and fever reducer, specifically indicated for the temporary relief of minor arthritis pain. The effects of the extended-release tablets can last up to 8 hours. The product is supplied in a package containing 80 gelatin-coated tablets, designed for ease of swallowing.

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 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 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 in swallowing.

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

Discontinuation and Consultation Patients should stop using this product and consult a doctor if any of the following occur: worsening pain or pain lasting more than 10 days; worsening fever or fever lasting more than 3 days; the emergence of new symptoms; 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

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 inactive ingredients in this formulation should refrain from use.

Patients are advised to stop using the product and consult a healthcare professional 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.

Prior to using this product, patients with liver disease should consult a healthcare provider. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use.

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 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. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. Patients are advised to verify the contents of any other medications with a healthcare provider or pharmacist if there is uncertainty regarding the presence of acetaminophen.

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. The product is intended for households without young children, indicating that caution is advised when considering its use in pediatric populations.

Geriatric Use

Elderly patients may experience challenges with swallowing large tablets or capsules, which could affect their ability to take this medication. Therefore, it is advised that individuals aged 65 and older consult with their healthcare provider prior to use if they have difficulty swallowing.

Additionally, geriatric patients with liver disease should seek medical advice before initiating treatment, as liver function may impact the safety and efficacy of the medication.

Furthermore, it is important for elderly patients who are concurrently taking the anticoagulant warfarin to consult with their doctor or pharmacist prior to use. This precaution is necessary to ensure safe management of potential drug interactions and to monitor for any adverse effects.

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 drug 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 absence of guidance 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 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 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 drinks per day while using this product, as excessive alcohol intake 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

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, 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.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data related to animal pharmacology and toxicology.

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 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 containing 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.

It is important to discuss with patients that this medication should not be used if they have difficulty swallowing large tablets or capsules, as individuals over the age of 65 may experience such difficulties. Additionally, patients should be cautioned against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained 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 intensifies 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 to seek immediate medical attention if a tablet becomes lodged in their throat, as this may 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 use 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 informed 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 before 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 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)