Menstrual Relief

Description

The product is identified by the National Drug Code (NDC) 76168-064-03 and is available in a count of 20 units. It features an enteric coating designed to minimize the risk of gastrointestinal discomfort.

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 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

There are no contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 6 caplets is exceeded within a 24-hour period. Additionally, liver damage may occur if this product is taken concurrently with other medications containing acetaminophen or if consumed with three or more alcoholic drinks daily.

Healthcare professionals should advise patients against using this product in conjunction with any other acetaminophen-containing medications, whether prescription or over-the-counter. Patients should be informed to consult a doctor or pharmacist if they are uncertain about the presence of acetaminophen in their medications. Furthermore, individuals with a history of allergic reactions to this product or any of its ingredients should refrain from use.

Prior to administration, it is essential to consult a healthcare provider if the patient has any of the following conditions: liver disease, glaucoma, difficulty urinating due to prostate enlargement, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking anticoagulants such as warfarin or those on sedatives or tranquilizers should seek advice from a healthcare professional before using this product.

While using this product, patients may experience drowsiness and should be cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which can exacerbate drowsiness. Special attention should be given to children, as excitability may occur. Patients should also be advised to exercise caution when driving or operating machinery. It is recommended to limit the intake of caffeine-containing products, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

Patients should be instructed to discontinue use and contact 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.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 6 caplets within 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. Patients are advised not to use this product with any other drug containing acetaminophen, whether prescription or nonprescription, and should consult a doctor or pharmacist 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.

Patients with liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or breathing problems such as emphysema or chronic bronchitis should seek medical advice before using this product. Additionally, those taking blood thinners such as warfarin or sedatives and tranquilizers should consult a healthcare professional prior to use.

While using this product, patients may experience drowsiness and should avoid alcoholic beverages, as well as be cautious when driving or operating machinery. Excitability may occur, particularly in children, and the combination of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. It is also recommended 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 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. Pregnant or breastfeeding individuals are advised to seek guidance from a health professional before using this product.

Drug Interactions

The concomitant use of this product with anticoagulants, specifically warfarin, 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.

When this product is used in conjunction with sedatives or tranquilizers, there is a potential for enhanced drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery. Monitoring for increased sedation is recommended, and dosage adjustments of sedatives or tranquilizers may be warranted based on the clinical response.

Additionally, the combined use of alcohol with this product, along with sedatives and tranquilizers, may further amplify drowsiness. It is recommended that patients limit alcohol consumption and be monitored for excessive sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Relief (acetaminophen, caffeine, pyrilamine). 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. There is a potential for excitability, particularly in children. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

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. The maximum allowable dosage is 6 caplets per day.

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. 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring informed decision-making for both maternal and fetal health.

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 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 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 the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing 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 3 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 cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Severe Liver Damage Taking more than 6 caplets within a 24-hour period, which is the maximum daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption during treatment and consider this factor when evaluating a patient's overall risk profile.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include monitoring liver function tests and providing supportive care as necessary. It is essential to educate patients on the importance of adhering to the recommended dosage and the potential consequences of overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident safety seal. It is imperative that the product is not used if the safety seal under the cap is broken or missing, as this indicates potential tampering.

For optimal storage, the product should be maintained at a controlled temperature between 62°F and 77°F. Proper adherence to these storage conditions is essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

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

Clinicians should counsel patients on several important considerations. Pregnant or breastfeeding individuals should seek professional advice before use. Patients may experience drowsiness and should avoid alcohol, as well as sedatives and tranquilizers, which can enhance this effect. Caution is advised when driving or operating machinery. Additionally, patients should limit caffeine intake, as excessive consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Excitability may also occur, particularly in children.

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)