Medline

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "B" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and iron oxides (red and yellow).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, flu, headache, toothache, muscular aches, backache, and pain related to premenstrual and menstrual periods. Additionally, it is indicated for the temporary relief of minor pain from arthritis and for the reduction of fever.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 to 2 tablets every 4 to 6 hours as needed while symptoms persist. The maximum dosage should not exceed 10 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total daily intake should not surpass 5 tablets in a 24-hour period, unless directed by a physician.

In the case of children under 6 years of age, it is recommended to consult a doctor 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 due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

The product should not be used for pain relief for more than 10 days unless specifically directed by a healthcare provider, as prolonged use may lead to adverse effects.

Additionally, the product is contraindicated for the treatment of fever for more than 3 days unless directed by a healthcare professional, to prevent potential complications associated with extended use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical warnings regarding liver safety:

Liver Warning

• Adults should not exceed 4,000 milligrams of acetaminophen in a 24-hour period, as this is the maximum daily dosage.

• Children should not take more than 5 doses within a 24-hour period.

• Caution is advised when this product is taken concurrently with other medications containing acetaminophen.

• Adults who consume 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

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 providers should advise patients to consult a doctor prior to use if they have liver disease or if the patient is a child experiencing pain due to arthritis. Additionally, it is recommended to seek guidance from a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin.

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

Monitoring and Follow-Up Patients should be advised to stop taking the product and consult a healthcare professional if any of the following occur:

• An adult's pain worsens or persists for more than 10 days.

• A child's pain worsens or lasts longer than 5 days.

• Fever worsens or lasts more than 3 days.

• Redness or swelling is observed.

• Symptoms do not improve.

• Any new symptoms arise.

These precautions are vital for ensuring the safe use of this product and minimizing the risk of adverse effects.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 4,000 milligrams within 24 hours, if a child takes more than 5 doses in 24 hours, if it is taken concurrently with other medications containing acetaminophen, or if an adult consumes 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.

Patients are advised to stop use and consult a healthcare professional if their pain worsens or persists beyond 10 days for adults or 5 days for children, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if symptoms do not improve, or if any new symptoms arise.

Prior to using this product, patients should consult a healthcare provider if they have liver disease or if a child is experiencing pain due to arthritis. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before use.

In cases of overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention 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 a healthcare professional prior to using this product. The interaction between this product 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 aged 6 years to under 12 years may take 1 tablet every 4 to 6 hours while symptoms persist, with a maximum of 5 tablets in a 24-hour period unless otherwise directed by a physician. For children under 6 years, consultation with a doctor is advised prior to use.

Healthcare professionals should be aware of the following warnings: if a child exceeds 5 doses within 24 hours, medical attention should be sought. Additionally, if a child's pain worsens or persists for more than 5 days, or if fever increases or lasts beyond 3 days, it is important to stop use and consult a doctor.

Before administering this medication, it is recommended to ask a doctor if the pediatric patient has pain associated with arthritis.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 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 safe use during pregnancy and lactation.

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 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 lack of data 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 advised of the potential risks associated with the use of this product, particularly due to the presence of acetaminophen. Severe liver damage may occur if an adult exceeds the maximum daily dosage of 4,000 milligrams within a 24-hour period. Additionally, the risk of liver damage is heightened in individuals who consume three or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients 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 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 understanding of potential risks associated with the compound in nonclinical settings.

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, as 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 that contains 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 for adults, or 5 days for children. Additionally, if a fever worsens or lasts more than 3 days, or if there is any redness or swelling, patients should stop use and seek medical advice.

Patients should also be counseled to stop using the medication if symptoms do not improve or if any new symptoms arise. It is essential to recommend that patients consult a doctor before using this medication if they have liver disease or if they are a child experiencing pain due to arthritis. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored 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 must 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 essential to ensure the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

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)