Medline

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, the flu, headache, toothache, muscular aches, backache, premenstrual and menstrual periods, and minor pain from arthritis. Additionally, it is indicated for the 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 advised to take 1 to 2 tablets every 6 hours as needed while symptoms persist. It is important not to exceed a total of 6 tablets within a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing instructions.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication 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.

Additionally, the product should not be used for pain relief for more than 10 days unless directed by a physician, nor for fever for more than 3 days unless specifically instructed by a healthcare provider.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of liver damage if not used according to the guidelines. Healthcare professionals should advise patients that severe liver damage may occur if they exceed 4,000 milligrams in a 24-hour period, which is the maximum daily dosage for this product. Additionally, patients should be cautioned against using this product in conjunction with other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

General precautions should be taken when considering the use of this product. Patients should consult a healthcare provider prior to use if they have liver disease or if they are children experiencing pain due to arthritis. Furthermore, it is advisable for patients to consult a doctor or pharmacist before use if they are concurrently taking the anticoagulant warfarin.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to seek emergency medical help or contact a Poison Control Center without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should also be advised to stop taking the product and consult a healthcare professional if any of the following occur: pain worsens or persists for more than 10 days, fever worsens or lasts more than 3 days, redness or swelling is observed, symptoms do not improve, or any new symptoms develop.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 4,000 milligrams 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.

It is advised that individuals consult a healthcare professional prior to use if they have liver disease or if they are children experiencing pain due to arthritis. The product should not be used concurrently with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist. Additionally, the product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare provider.

Patients are instructed to stop use and consult a doctor if pain worsens or persists beyond 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if symptoms do not improve, or if any new symptoms arise. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare professional before using this product.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is recommended prior to use. It is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center should be made, as prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients with arthritis-related pain should consult a healthcare professional before use. For children under 12 years of age, it is advised to seek medical guidance prior to administration.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 evaluated in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and 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 individuals with reduced kidney function, as the absence of detailed 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 be aware that this product contains acetaminophen, which carries a risk of severe liver damage. The maximum recommended daily dose of acetaminophen is 4,000 milligrams; exceeding this limit may result in significant hepatic injury.

Additionally, patients should be cautioned against the concurrent use of this product with other medications containing acetaminophen, as this can also lead to severe liver damage. Furthermore, the consumption of three or more alcoholic drinks per day while using this product may increase the risk of liver injury.

It is advised that patients with liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to mitigate the risk of adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 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 in the event of an overdose, emphasizing that prompt medical attention is critical 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 drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this medication for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. Patients should be advised to discontinue use and consult a doctor if their pain worsens or persists beyond 10 days, or if their fever worsens or lasts more than 3 days. Additionally, patients should be instructed to stop use and seek medical advice if they experience any redness or swelling, if symptoms do not improve, or if any new symptoms arise.

Patients with liver disease should be advised to consult a doctor before using this medication. Furthermore, healthcare providers should recommend that parents or guardians of children with arthritis-related pain seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20–25°C (68–77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the inner seal is broken or missing, as this may compromise the product's safety and effectiveness. Proper handling and storage conditions are crucial to ensure the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)