Menstrual Relief

Description

Acetaminophen, Caffeine, and Pyrilamine Maleate Tablets are formulated to contain 500 mg of Acetaminophen, 60 mg of Caffeine, and 15 mg of Pyrilamine Maleate per tablet. The product is packaged in 25 pouches, with each pouch containing 2 tablets.

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 over 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 doctor for appropriate dosing guidance.

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.

• History of allergic reaction to this product or any of its ingredients, 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 that the risk of liver injury increases if they exceed the maximum daily dosage of 6 tablets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic beverages daily while taking this product.

Patients should be informed of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of any skin or general allergic reaction, patients must discontinue use immediately and seek medical assistance.

Prior to recommending this product, healthcare professionals should inquire about the patient's medical history. It is particularly important to consult a physician if the patient has liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or respiratory conditions such as emphysema or chronic bronchitis. Additionally, patients taking anticoagulants such as warfarin or those on sedatives or tranquilizers should also be advised to consult a healthcare provider before use.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) 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 be advised to discontinue use and consult a healthcare professional if any 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.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of 6 tablets within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin or allergic reactions, which may manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. In the event of any skin or general allergic reaction, it is imperative to discontinue use and seek immediate medical assistance.

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Additionally, individuals with liver disease, glaucoma, difficulty urinating due to prostate enlargement, or breathing problems such as emphysema or chronic bronchitis should consult a healthcare professional prior to use.

Caution is advised for patients taking blood thinners such as warfarin or those on sedatives or tranquilizers, as interactions may occur. While using this product, patients may experience drowsiness, and it is recommended to avoid alcoholic beverages, as well as to be cautious when driving or operating machinery. Excitability may also occur, particularly in children.

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 heartbeat.

Patients are advised to discontinue use and consult a healthcare provider if any 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.

Drug Interactions

Concurrent use 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 the anticoagulant warfarin should consult a healthcare professional prior to using this medication. The combination may necessitate careful monitoring of INR levels to avoid an increased risk of bleeding.

Additionally, individuals using sedatives or tranquilizers are advised to seek guidance from a healthcare provider before initiating treatment. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Relief (acetaminophen, caffeine and pyrilamine maleate 500 mg, 60 mg and 15 mg). 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, not to exceed 6 tablets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately 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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information 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, which contains acetaminophen. 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 may further increase the risk of liver injury.

It is also advised that patients consuming three or more alcoholic drinks daily refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Patients with a known history of liver disease should consult a healthcare professional prior to using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in these individuals to prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. 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, vigilance and timely action are essential in managing overdose situations effectively.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential 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 containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients to discontinue use and consult a doctor if they experience any new symptoms, or if they notice redness or swelling. Additionally, patients should be advised to stop using the product if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

Patients may experience drowsiness while using this product; therefore, they should be cautioned against consuming alcoholic beverages, as well as using sedatives or tranquilizers, which may enhance drowsiness. Care should be taken when driving or operating machinery due to the potential for impaired alertness.

Patients should also be informed that excitability may occur, particularly in children. It is advisable to limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and, in some cases, 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 encouraged to consult a doctor if they have liver disease, glaucoma, difficulty urinating due to prostate enlargement, 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 seek advice from a doctor or pharmacist prior to use.

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 necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets taken with water every 6 hours as needed, with a maximum of 6 tablets per day. For children under 12 years, consultation with a doctor is advised prior to use.

Patients should be counseled on potential drowsiness and advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness. Caution is recommended when driving or operating machinery. Additionally, patients should limit the intake of caffeine-containing products to prevent symptoms such as nervousness, irritability, sleeplessness, and occasional rapid heartbeat. Pregnant or breastfeeding individuals should consult a healthcare professional before use.

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)