Menstrual Relief

Description

Multi-Symptom Menstrual Relief is formulated as a 24-caplet dosage form containing the active ingredients acetaminophen, caffeine, and pyrilamine maleate. This product serves as a pain reliever, diuretic, and antihistamine, providing multi-symptom relief for conditions such as cramps and bloating, fatigue, backache, and headache. The product is packaged with a tamper evident warning, indicating that it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. It is important to note that this product is not manufactured or distributed by Bayer HealthCare LLC, the owner of the registered trademark Midol® Complete.

Uses and Indications

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

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 imperative that patients do not exceed a total of 6 caplets in 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 a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a physician prior to use if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are currently taking blood thinners, such as warfarin, or sedatives and tranquilizers.

In cases of 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 also be advised to discontinue use 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 more than 3 days. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, which can range from serious warnings to common side effects.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use this product in conjunction with other medications containing acetaminophen, 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, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they have a history of allergic reactions to acetaminophen or any of its ingredients, or if they are concurrently taking any other drug containing acetaminophen, whether prescription or nonprescription. It is recommended that patients consult a healthcare professional prior to use if they have difficulty urinating due to prostate enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, patients taking blood thinners like warfarin or sedatives and tranquilizers should also seek advice from a doctor or pharmacist before using this product.

While using this product, drowsiness may occur, and patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Excitability may also be observed, particularly in children. Caution is recommended when driving or operating machinery. Patients should limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients should discontinue use and consult a doctor 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 more than 3 days, as these may indicate a serious condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication. The combination may necessitate careful monitoring due to potential interactions that could affect anticoagulation levels.

The concomitant use of alcohol, sedatives, and tranquilizers is cautioned against, as these substances may enhance drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery.

Additionally, it is recommended to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects, including nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. Monitoring for these symptoms is advised to ensure patient safety and comfort.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Relief (acetaminophen, caffeine, pyrilamine maleate). 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 caplets taken with water, which may be repeated every 6 hours as needed, without exceeding 6 caplets in a 24-hour period.

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

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 potential adverse effects or changes in efficacy, 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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than three alcoholic drinks per day while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance 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.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 indicated that acetaminophen may be associated with severe skin reactions. These reactions can manifest as symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

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

Patients should be informed that they must not use this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, it is important to counsel patients against using 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 a doctor or pharmacist.

Patients should be instructed to discontinue use and consult a doctor if they experience new symptoms, or if they notice redness or swelling. They should also be advised to stop use and seek medical advice if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, as these may indicate a serious condition.

While using this product, patients should be made aware that drowsiness may occur, and they should avoid consuming alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. It is also important to inform patients that excitability may occur, particularly in children, and they should exercise caution when driving or operating machinery.

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

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

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to refrain from using the product if the outer package is opened or if the blister is torn or broken. The expiration date and lot number can be found on the end flap of the packaging.

For optimal storage, the product should be maintained at a temperature of 25ºC (77ºF). Temporary excursions are permissible within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 6 hours as needed, with a maximum of 6 caplets per day. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients about potential side effects, including drowsiness and excitability, particularly in children. Caution is advised when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients are encouraged to limit caffeine intake, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and occasionally rapid heart rate. The recommended dose contains approximately the same amount of caffeine as a cup of coffee, and patients should avoid alcoholic beverages while taking this product.

Drug Information (PDF)

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

View product document (PDF)