Extra Strength Acetaminohpen

Description

Mapap is a pain reliever and fever reducer containing Extra Strength Acetaminophen at a dosage of 500 mg per unit. The product is formulated with a Rapid Burst Cherry flavor and is alcohol-free. It is indicated for use in individuals aged 12 years and older. Mapap is comparable to the active ingredient found in Extra Strength Tylenol®.

The product is distributed by Major Pharmaceuticals, located at 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, USA. It features a tamper-evident safety seal; users are advised not to use the product if the printed safety seal around the dosage cup or under the cap is broken or missing. For inquiries, customers can contact the service line at 1-877-753-3935, available Monday through Friday from 9 AM to 5 PM EST. This product is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Extra Strength Tylenol®.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, 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 older are advised to take 30 mL every 6 hours as needed while symptoms persist. It is imperative not to exceed 4 doses within a 24-hour period and to limit the duration of use to a maximum of 10 days unless otherwise directed by a healthcare professional.

For accurate dosing, the provided dosing cup must be used; no other dosing devices should be employed. The dosing cup should be kept with the product to ensure proper measurement.

Children under 12 years of age should not use this medication. It is essential to adhere strictly to these guidelines to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or non-prescription. The risk of acetaminophen overdose may increase, leading to potential hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers must emphasize the importance of adhering to the recommended dosage to prevent overdose, which can lead to liver damage. In cases of accidental overdose, it is crucial to seek professional medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even if no immediate signs or symptoms are apparent.

Patients should be advised to discontinue use and consult their healthcare provider if they experience any of the following: worsening pain that persists for more than 10 days, a fever that worsens or lasts longer than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses. The product contains acetaminophen, which can lead to severe liver damage if the following conditions are met: exceeding 4000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be instructed to stop using the product 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 there is any redness or swelling, as these may indicate a serious underlying condition.

It is recommended that patients with liver disease consult a doctor prior to using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before use to avoid potential interactions.

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. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours while symptoms persist, with a maximum duration of use not exceeding 10 days unless directed by a healthcare professional.

Healthcare providers should be aware of the critical need for quick medical attention in cases of overdose, as this is essential for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the treatment. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours while symptoms persist, with a maximum duration of use not exceeding 10 days unless directed by a healthcare professional. It is crucial to keep this medication out of reach of children to prevent accidental ingestion.

In the event of an accidental overdose, prompt medical attention is essential for both elderly patients and children, highlighting the importance of monitoring and adhering to prescribed dosages.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety profile in these populations has not been fully established, and healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 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 important to note that severe liver damage may occur if patients exceed the following limits:

• More than 4000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications that also contain acetaminophen.

• Consumption of three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be closely monitored for signs of liver damage. It is advisable for these patients to consult with a healthcare professional before using this product to ensure safe and appropriate use.

Overdosage

In cases of acetaminophen overdosage, significant health risks are associated with excessive intake.

Risk of Severe Liver Damage Acetaminophen is known to pose a risk of severe liver damage when dosages exceed 4000 mg within a 24-hour period. Healthcare professionals should be vigilant in monitoring patients who may inadvertently exceed this threshold.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to similar risks of severe liver damage. It is crucial for healthcare providers to assess all medications a patient is taking to prevent unintentional overdosing.

Furthermore, patients who consume three or more alcoholic beverages daily while using acetaminophen are at an increased risk for severe liver damage. This interaction necessitates careful consideration and counseling regarding alcohol consumption during treatment.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function tests and providing supportive care as needed. Prompt intervention is essential to mitigate the potential for serious liver injury.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients that taking more than the recommended dose of the medication may lead to liver damage. In the event of an accidental overdose, it is crucial to seek professional assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential 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 non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, patients should stop using the medication and seek medical advice if their fever worsens or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Additionally, patients should be advised to consult a doctor before using this medication if they have a history of liver disease. It is also important for patients to speak with a doctor or pharmacist before use if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a container that includes a dosing cup for accurate measurement. It should be stored at a temperature range of 20-25ºC (68-77ºF) and must not be refrigerated. Additionally, the product should be protected from light to maintain its integrity. Proper handling includes ensuring that the dosing cup remains with the product at all times.

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 Extra Strength Acetaminohpen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)