Acetaminophen/Caffeine/Pyrilamine maleate

Description

Walgreens Menstrual Complete Pain Relief is a pharmaceutical product designed to alleviate menstrual discomfort. The formulation includes active ingredients that target pain relief associated with menstrual symptoms. The product is available in a dosage form suitable for oral administration. Specific details regarding the chemical composition, molecular weight, and inactive ingredients are not provided. The appearance of the product is consistent with standard over-the-counter pain relief medications.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including cramps, bloating, water-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 12 years and older are instructed to take 2 gelcaps with water. This dosage may be repeated every 6 hours as needed. It is imperative that patients do not exceed a total of 6 gelcaps in a 24-hour period.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to administration to determine appropriate dosing and safety.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 6 gelcaps within a 24-hour period. Caution is warranted if the patient is concurrently using other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin or allergic reactions. Symptoms indicative of such reactions include hives, blisters, rash, skin reddening, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients must discontinue use immediately and seek medical assistance.

Patients should be advised against using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare provider is recommended. Additionally, individuals with a history of allergic reactions to this product or any of its components should refrain from its use.

Before initiating treatment, patients should consult a healthcare professional if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to prostate enlargement, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, patients taking anticoagulants such as warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to use.

While using this product, patients may experience drowsiness and should be cautioned to avoid alcoholic beverages, as well as to be aware that excitability may occur, particularly in children. The combination of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Patients should exercise caution when driving or operating machinery. It is also advisable to limit the intake of caffeine-containing products, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee.

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 critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six gelcaps within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include hives, blisters, rash, skin reddening, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use and seek medical assistance immediately.

While using this product, patients may experience drowsiness and should avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Excitability has been reported, particularly in children. Caution is advised when driving or operating machinery. Additionally, patients are encouraged to limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should discontinue use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Patients taking blood thinners, such as warfarin, should consult a healthcare professional prior to using this medication. The interaction may necessitate careful monitoring of coagulation parameters to avoid increased bleeding risk.

Additionally, the concurrent use of alcohol, sedatives, or tranquilizers may enhance the sedative effects of this medication, leading to increased drowsiness. Caution is advised, and patients should be monitored for excessive sedation or respiratory depression when these substances are used together.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 6 gelcaps within a 24-hour period. Exceeding this dosage, using other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in these patients to ensure safety and 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 intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, vigilance and timely action are essential in managing potential overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions and severe allergic reactions. Reported symptoms include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is advised to discontinue use 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 essential to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. They should stress 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 significantly mitigate potential health risks associated with overdose situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)