Menstrual Pain Relief Complete

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including cramps, bloating, water retention, weight gain, headache, backache, muscle aches, and fatigue.

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 caplets with water. This dosage may be repeated every 6 hours as needed. It is essential not to exceed a total of 6 caplets within a 24-hour period.

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

Contraindications

Use of this product is contraindicated in individuals with a history of allergic reactions to this product or any of its ingredients. Additionally, it should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, 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 to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this may increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product can further elevate the risk of liver damage.

Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, rash, hives, facial swelling, or respiratory symptoms such as wheezing and shock. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of suspected overdose, it is imperative to obtain emergency medical help 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.

Patients should be instructed to stop taking the product and consult a healthcare provider if new symptoms arise, or if redness or swelling is observed. Additionally, if pain persists or worsens beyond 10 days, or if fever intensifies or lasts more than 3 days, medical advice should be sought. 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.

Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for new symptoms, such as redness or swelling, and should consult a doctor if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Acetaminophen has notable interactions with other substances that may affect its safety and efficacy.

Warfarin: Co-administration of acetaminophen and warfarin may increase the risk of bleeding. It is recommended to monitor the International Normalized Ratio (INR) closely in patients receiving both medications to ensure safe therapeutic levels.

Alcohol: The concurrent use of acetaminophen and alcohol may enhance the sedative effects of acetaminophen, leading to increased drowsiness. It is advised to avoid alcoholic beverages while using acetaminophen to mitigate this risk.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Pain Relief Complete (acetaminophen, pyrilamine maleate, caffeine). 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. There is a potential for increased excitability in children, which should be monitored. For patients aged 12 years and older, the recommended dosage is 2 caplets taken with water, with the option to repeat every 6 hours as needed, not to exceed 6 caplets in a 24-hour period.

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 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 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 be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential for patients with hepatic impairment to minimize the risk of adverse effects. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and efficacy.

Overdosage

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

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. This risk is compounded when acetaminophen is taken concurrently with other medications that also contain acetaminophen, as this can lead to cumulative dosing that exceeds safe limits.

Additionally, the risk of severe liver damage is heightened in patients who consume three or more alcoholic drinks daily while using acetaminophen. Alcohol can exacerbate the hepatotoxic effects of acetaminophen, leading to increased potential for liver injury.

Recommended Actions In the event of suspected overdosage, it is imperative for healthcare professionals to assess the patient's condition promptly. Monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote may be warranted, depending on the severity of the overdose and the time elapsed since ingestion. Immediate medical intervention is crucial to mitigate the risk of irreversible liver damage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of potential risks related to these aspects remains incomplete.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include severe skin reactions such as skin reddening, blisters, rash, hives, and facial swelling. Additionally, instances of asthma, characterized by wheezing, have been reported.

In cases of severe skin reactions, it is advised that patients discontinue use of the product and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the necessity of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose.

Providers should also inform patients that prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can help ensure the safety and well-being of patients in case of any adverse events.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25ºC (77ºF). Temporary excursions are permitted within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)