Uline Acetaminophen Extra Strength

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor arthritis pain, backache, the common cold, toothache, 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 and children aged 12 years and over are instructed to take 2 tablets every 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days unless specifically advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

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 another medication, 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.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to minimize the risk of liver injury:

• The maximum daily dosage should not exceed 4,000 mg within a 24-hour period.

• Patients should avoid concurrent use with other medications that contain acetaminophen.

• Consumption of three or more alcoholic beverages daily while using this product is contraindicated.

In addition to the liver warning, there is an allergy alert associated with acetaminophen. It may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

In the event of an overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should also be instructed to stop taking the product and consult a healthcare provider if any of the following occur:

• Pain worsens or persists for more than 10 days.

• Fever intensifies or lasts longer than 3 days.

• New symptoms develop.

• Redness or swelling is observed.

These signs may indicate a serious underlying condition that requires further evaluation. Regular monitoring and appropriate laboratory tests may be warranted based on the clinical scenario and patient history.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 4,000 mg within a 24-hour period, particularly when combined with other medications containing acetaminophen or when consuming three 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.

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

Individuals with liver disease should consult a doctor prior to using this product. Additionally, it is recommended that patients or pharmacists be consulted before use in the presence of liver disease to ensure safety and appropriateness of treatment.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Uline Acetaminophen Extra Strength (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 hours as needed, with a maximum of 6 tablets in a 24-hour period, unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

It is important to note that quick medical attention is essential in cases of overdose for both adults and children, even if no signs or symptoms are immediately apparent. Additionally, this product is intended for use in households without young children.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication if they have a history of liver disease. This precaution is essential to ensure the safe use of the medication, as liver function may be compromised in geriatric patients, potentially affecting drug metabolism and clearance. Monitoring and appropriate dose adjustments may be necessary based on individual liver function and overall health status.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4,000 mg, as exceeding this limit may lead to severe liver damage.

Additionally, patients must avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of hepatotoxicity. Furthermore, consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the potential for liver injury.

Monitoring of liver function is recommended for patients with compromised liver function who are prescribed this product. Regular assessment of liver enzymes and overall hepatic health should be considered to ensure patient safety and to mitigate the risk of adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen beyond the recommended limits.

Maximum Daily Dosage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 4,000 mg of acetaminophen within a 24-hour period. This threshold represents the maximum daily amount recommended for safe use.

Combination with Other Medications It is critical to note that the risk of severe liver damage is heightened when acetaminophen is taken in conjunction with other medications that also contain acetaminophen. Healthcare providers should ensure that patients are not inadvertently exceeding the safe dosage through combination therapies.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk for severe liver damage. It is advisable for healthcare professionals to counsel patients on the dangers of concurrent alcohol use and acetaminophen, emphasizing the importance of adhering to safe consumption guidelines.

In the event of suspected overdosage, immediate medical evaluation is warranted. Monitoring liver function and providing supportive care are essential components of management.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section, nor is there any data available concerning 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 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 instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, they should stop using the medication and seek medical advice if their fever worsens or lasts longer than 3 days. Patients should also be advised to stop use 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 should be reminded to consult a doctor before using this medication if they have a history of liver disease. This precaution is essential to ensure their safety and the effectiveness of the treatment.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at room temperature, specifically within the range of 59º-86ºF (15º-30ºC). Healthcare professionals should ensure that any opened or torn packets are not used, as this may compromise the product's quality and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)