Acetaminophen/Caffeine/Pyrilamine maleate

Description

Maximum Strength Menstrual Complete is a combination medication formulated to provide relief from menstrual discomfort. Each caplet contains 500 mg of acetaminophen, 60 mg of caffeine, and 15 mg of pyrilamine maleate. The product is presented in a dosage form of caplets, with a total of 20 caplets per package. This formulation is comparable to the active ingredients found in Midol® Complete. The product is distributed by Healthlife of USA LLC, located in Rahway, NJ 07065. Further information can be accessed at www.healthlifeofusa.com.

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 aged 12 years and older are advised to take 2 tablets with water. This dosage may be repeated every 6 hours as needed, with a maximum limit of 6 tablets per day.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance. It is imperative that the recommended dosage is not exceeded to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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.

• In individuals with a history of allergic reactions to this product or any of its components, as this may lead to severe hypersensitivity reactions.

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 recommended dosage, which is a maximum of 6 tablets within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

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

Patients should be advised to stop using the product and consult a 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 longer than 3 days.

In cases of suspected overdose, it is imperative to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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 the maximum recommended dosage of 6 tablets in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may lead to severe skin or allergic reactions. Symptoms of such reactions can include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and in extreme cases, shock. If any signs of a skin or general allergic reaction manifest, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for other adverse reactions. They are encouraged to stop use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

Drug Interactions

The concomitant use of this product with certain medications may lead to significant interactions that require careful consideration.

Anticoagulants The use of warfarin, a blood-thinning agent, may interact with this product. Monitoring of INR levels is advised to ensure therapeutic efficacy and safety.

CNS Depressants Co-administration with sedatives or tranquilizers may result in enhanced sedative effects. Additionally, the combined use of alcohol, sedatives, and tranquilizers can increase drowsiness when using this product. Caution is recommended, and dosage adjustments may be necessary based on the clinical response.

Acetaminophen This product should not be used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription, to avoid the risk of acetaminophen overdose.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Complete. 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. For adolescents aged 12 years and older, the recommended dosage is 2 tablets taken with water, which may be repeated every 6 hours as needed, without exceeding a total of 6 tablets in one day.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and pediatric patients, even if no signs or symptoms are apparent.

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 should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

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 maximum daily dosage of 6 tablets within a 24-hour period. Additionally, patients should avoid concomitant use with 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 to fewer than 3 alcoholic drinks per day while using this product. Given the potential for increased susceptibility to acetaminophen-related hepatotoxicity in this population, careful consideration of liver function and adherence to recommended dosage guidelines is essential to minimize the risk of severe liver damage. Regular monitoring of liver function tests may be warranted in patients with significant hepatic impairment.

Overdosage

Overdosage of this product may result in significant hepatic injury. Healthcare professionals should be aware that the maximum recommended dosage is 6 tablets within a 24-hour period. Exceeding this limit can heighten the risk of severe liver damage.

It is crucial to note that concomitant use of this product with other medications containing acetaminophen further elevates the potential for liver toxicity. Additionally, patients who consume three or more alcoholic beverages daily while using this product are at an increased risk of experiencing severe liver damage.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should monitor liver function and consider appropriate management strategies to mitigate the risk of hepatic injury.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain 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 to discontinue use and consult a doctor if they experience new symptoms, or if they notice any redness or swelling. Additionally, patients should be advised to stop using the product if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days.

Patients should be made aware that drowsiness may occur while using this product, and they should avoid alcoholic beverages during its use. Furthermore, excitability may be observed, particularly in children. Healthcare providers should caution patients that the combination of alcohol, sedatives, and tranquilizers may enhance drowsiness, and they should exercise caution when driving or operating machinery.

Patients should limit their intake of caffeine-containing medications, foods, or beverages, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Before using this product, patients should be advised to consult a doctor if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or any breathing problems such as emphysema or chronic bronchitis. Additionally, patients taking the blood-thinning medication warfarin, or those using sedatives or tranquilizers, should seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the safety seal under the cap before use; the product should not be utilized if the seal is broken or missing.

Storage conditions require the product to be maintained at room temperature. Proper handling and storage are crucial to ensure the integrity and safety of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets orally with water every 6 hours as needed, without exceeding 6 tablets per day. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek medical advice before use if they have liver disease, glaucoma, urinary difficulties due to prostate enlargement, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking blood thinners like warfarin or those on sedatives or tranquilizers should consult a healthcare professional. Users may experience drowsiness and should avoid alcohol, as well as be cautious when driving or operating machinery. It is also advisable to limit caffeine intake to prevent potential side effects such as nervousness and rapid heartbeat. Pregnant or breastfeeding patients should consult a healthcare professional before use.

Drug Information (PDF)

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

View product document (PDF)