Acetaminophen

Description

Acetaminophen is presented in the form of extended-release tablets, each containing 650 mg of the active ingredient. These gelatin-coated tablets are designed for the temporary relief of minor arthritis pain and provide effects lasting up to 8 hours. The product is packaged in a container containing 20 geltabs. Caution is advised against concurrent use with other medications containing acetaminophen. This formulation is distributed by Ohm Laboratories Inc.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including muscular aches, backache, headache, toothache, the common cold, minor pain of arthritis, 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 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, 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 who have difficulty swallowing large tablets or capsules, particularly in patients over 65 years of age, as this may pose a risk of choking or inadequate dosing.

Additionally, use is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients present in this 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, under specific circumstances. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 6 geltabs within a 24-hour period. Caution is warranted if the patient is concurrently using other medications that contain acetaminophen or consuming three or more alcoholic beverages daily while using this product.

Patients with a history of liver disease should be instructed to consult a physician prior to using this product. Additionally, those taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before initiating treatment.

Patients are advised to discontinue use and consult a physician if any of the following occur: worsening pain or pain persisting beyond 10 days, fever that worsens or lasts more than 3 days, the emergence of new symptoms, the presence of redness or swelling, or if a tablet becomes lodged in the throat. These symptoms may indicate a serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 geltabs 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 be advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Individuals who have difficulty swallowing large tablets or capsules, particularly those over 65 years of age, should avoid this product. Additionally, patients with a known allergy to acetaminophen or any of the inactive ingredients in this product should not use it.

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

Patients are instructed to discontinue use and consult a doctor 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 critical for patients to seek medical assistance 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 immediately apparent.

Drug Interactions

The concomitant use of acetaminophen with warfarin may elevate the risk of bleeding due to the anticoagulant effects of warfarin. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Additionally, acetaminophen should not be used in conjunction with any other medications that contain acetaminophen, whether they are prescription or nonprescription. This precaution is essential to avoid the risk of acetaminophen overdose, which can lead to severe hepatic injury.

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, particularly those aged 65 and older, may experience difficulty swallowing the tablets. 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.

To ensure safety, elderly patients should adhere to the recommended dosage, which should not exceed 6 geltabs within a 24-hour period. Furthermore, the use of this medication should not extend beyond 10 days unless directed by a healthcare professional. Careful monitoring and adherence to these guidelines are essential to mitigate potential risks associated with medication use in this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with its use during pregnancy.

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 concurrent liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of renal impairment.

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 geltabs within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may 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 not recommended, 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

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

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 who exceed the recommended dosage or have underlying liver disease. 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 renal 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, as this may pose a challenge, particularly for individuals over the age of 65. Additionally, patients should be advised not to use the 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, if their fever intensifies or lasts longer than 3 days, or if they experience any new symptoms. They should also be advised to seek medical advice if they notice any redness or swelling, or if a tablet becomes lodged in their throat, as these may indicate a serious condition.

Furthermore, healthcare providers should recommend that patients consult a doctor prior to use if they have a history of liver disease. It is also essential to advise patients to speak with a doctor or pharmacist before using this medication if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a container that features a tamper-evident seal. It is essential to refrain from using the product 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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult 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 medical assistance or contact a Poison Control Center immediately 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)