Menstrual Relief

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 bloating, headache, water-weight gain, cramps, backache, fatigue, and muscle aches.

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 caplets with water. This dosage may be repeated every 6 hours as needed. It is imperative that the total daily intake does not exceed 6 caplets.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance. Healthcare professionals should ensure that patients are informed not to exceed the recommended dose.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication 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.

Additionally, this product is contraindicated in individuals with a history of allergic reactions to this product or any of its components.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic beverages daily while taking this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

General precautions should be taken for patients with specific medical conditions. Prior to use, patients should consult a healthcare provider if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking anticoagulants like warfarin or sedatives and tranquilizers, as these may interact with acetaminophen.

In cases of accidental 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 symptoms.

Patients should be advised to 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. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it concurrently with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, and should consult a healthcare professional if uncertain about the presence of acetaminophen in other medications. Individuals with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

Before using this product, patients should consult a doctor if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, those taking blood thinners like warfarin or sedatives and tranquilizers should seek advice from a doctor or pharmacist prior to use.

While using this product, patients should avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Excitability may occur, particularly in children, and caution is advised when driving or operating machinery. Patients may experience drowsiness and should 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.

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

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before use. This product should be kept out of reach of children, and in the event of an accidental overdose, immediate medical help or contact with a Poison Control Center is crucial, as prompt medical attention is necessary for both adults and children, even if no signs or symptoms are evident.

Drug Interactions

The concomitant use of warfarin, a blood-thinning agent, with this product containing acetaminophen may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this product, which contains acetaminophen, caffeine, and pyrilamine maleate, may enhance drowsiness. Patients should be cautioned about the potential for increased sedation and advised to avoid activities that require full alertness until they are aware of how the combination affects them.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Relief (acetaminophen, caffeine and 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 using this product. When administered, excitability may occur, particularly in children. It is crucial to keep the product out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay, as prompt attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

For adolescents and adults 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

There is no specific information available 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. It is advisable to monitor these patients closely for any 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. 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of 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 be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, especially when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

In the event of an accidental 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, 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. Therefore, vigilance and timely action are essential in managing potential overdose situations effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

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 accidental 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 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, as these may indicate a serious condition.

Patients should be cautioned against consuming alcoholic beverages while using this product, as it may increase the risk of drowsiness. They should also be made aware that excitability may occur, particularly in children, and that caution is advised when driving or operating machinery due to the potential for drowsiness.

Furthermore, patients should limit their intake of caffeine-containing medications, foods, or beverages while using this product, 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.

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. Additionally, patients taking the blood-thinning medication warfarin, or those using sedatives or tranquilizers, should be advised to seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied with specific labeling details, including the expiration date and lot number, which can be found on the end flap of the packaging. It is essential to store the product at a controlled room temperature of 25ºC (77ºF). Temporary excursions from this temperature are permissible, provided they remain within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

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 to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

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)