Mapap

Description

Mapap 325mg tablet is formulated as a solid dosage form in the strength of 325 mg. The product is presented in tablet form, designed for oral administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, 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 older are advised to take 2 tablets every 4 to 6 hours as needed while symptoms persist. The maximum allowable dosage is 12 tablets within a 24-hour period.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms last, with a maximum of 5 tablets in a 24-hour period.

It is important to note that the use of adult Regular Strength products is contraindicated in children under 6 years of age, as this may result in an overdose of acetaminophen, potentially leading to severe liver damage.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or non-prescription, 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, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the 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 the following circumstances: if an adult consumes more than 12 tablets within a 24-hour period, 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.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin. Pregnant or breastfeeding individuals should also consult a healthcare professional before using this product.

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 if no signs or symptoms are initially apparent.

Patients should discontinue use and contact a healthcare provider if any of the following occur: pain worsens or persists for more than 10 days in adults and children, pain worsens or lasts more than 5 days in children under 12 years, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 12 tablets within 24 hours for adults or 5 doses for children. The risk of liver damage is further increased if the product is taken in conjunction with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is advised to consult a healthcare professional before use if the patient has liver disease or is taking the anticoagulant warfarin.

Patients are instructed to discontinue use and seek medical advice if pain worsens or persists beyond 10 days in adults and children, or if pain lasts more than 5 days in children under 12 years. They should also seek medical attention if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

In cases of overdose, which may result in liver damage, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider or pharmacist to avoid potential overdose and associated adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets in a 24-hour period. For children under 6 years, the use of adult Regular Strength products is contraindicated, as this may lead to an overdose of acetaminophen, resulting in potential liver damage.

Healthcare professionals should be aware of the liver warning associated with this medication; severe liver damage may occur if a child exceeds 5 doses within 24 hours. Additionally, if pain worsens or persists for more than 5 days in children under 12 years, it is advised to discontinue use and consult a physician.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 medication in 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. Due to the presence of acetaminophen, there is a significant risk of severe liver damage, particularly under certain conditions.

Adults should not exceed 12 tablets within a 24-hour period, as this is the maximum daily dosage. For pediatric patients, the maximum is limited to 5 doses in a 24-hour period. Additionally, patients must be cautious when using this product in conjunction with other medications that contain acetaminophen, as this can further increase the risk of liver damage.

Patients with a history of alcohol consumption should be particularly vigilant; the concurrent use of this product with the consumption of 3 or more alcoholic drinks daily may heighten the risk of liver injury.

In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. It is crucial to contact a Poison Control Center or seek medical help promptly, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay at 1-800-222-1222. Prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Dosage Thresholds for Overdosage

Severe liver damage can occur under specific circumstances. For adults, the risk increases significantly if more than 12 tablets are ingested within a 24-hour period, which represents the maximum daily dosage. In children, the threshold for concern is more than 5 doses within the same timeframe.

Drug Interactions and Alcohol Consumption

The potential for severe liver damage is further exacerbated when the product is taken in conjunction with other medications that contain acetaminophen, whether they are prescription or nonprescription. Additionally, adults who consume three or more alcoholic beverages daily while using this product are at an increased risk for liver damage.

Precautions and Recommendations

Healthcare professionals should advise patients to avoid the concurrent use of any other drugs containing acetaminophen. If there is uncertainty regarding whether a medication contains acetaminophen, it is recommended to consult a healthcare provider, such as a doctor or pharmacist, for clarification.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Adverse drug events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, (800) 616-2471. This information contributes to the ongoing monitoring of the drug's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist.

Patients should be cautioned against using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the product. Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience any of the following: worsening pain that lasts more than 10 days in adults and children, worsening pain that persists for more than 5 days in children under 12 years, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious condition.

It is advisable for patients to consult a doctor before using this medication if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a healthcare professional before using this product. Providers should also emphasize the overdose warning, informing patients that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Storage and Handling

The product is supplied in tamper-evident blister units. It is essential to inspect the packaging prior to use; do not utilize any blister units that are broken or damaged.

For optimal preservation, the product should be stored at room temperature.

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. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center 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 Mapap, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)