Menstrual Complete Gelcaps

Description

No relevant information is available for SPL code 34089-3.

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

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 gelcaps within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Severe skin or allergic reactions may occur with acetaminophen. Symptoms indicative of such reactions include hives, blisters, rash, skin reddening, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Healthcare professionals should advise patients to consult a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen. Additionally, individuals with a history of allergic reactions to this product or any of its ingredients should refrain from use.

Before using this product, patients should consult a healthcare provider if they have liver disease, glaucoma, difficulty urinating due to prostate enlargement, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the patient is taking blood thinners like warfarin or is on sedatives or tranquilizers.

While using this product, patients may experience drowsiness and should avoid alcoholic beverages. Excitability may occur, particularly in children. The combination of alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Caution is advised when driving or operating machinery. Patients should also 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. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help, regardless of whether symptoms are present.

Patients are advised to discontinue use and contact their 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.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six gelcaps within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

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

While using this product, patients may experience drowsiness and should avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Excitability has been reported, particularly in children. Caution is advised when driving or operating machinery. Additionally, 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. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients are instructed 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 more than 3 days.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients are advised to consult a healthcare professional prior to using this medication if they are concurrently taking the anticoagulant warfarin. The combination may necessitate careful monitoring due to potential alterations in anticoagulation effects.

Additionally, caution is recommended for individuals using sedatives or tranquilizers alongside this medication. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks that require alertness.

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

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Complete Gelcaps (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 gelcaps taken with water, which may be repeated every 6 hours as needed, without exceeding 6 gelcaps 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

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. 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 safe use during pregnancy and lactation.

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

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 warranted 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 the maximum daily dosage of 6 gelcaps within a 24-hour period. Additionally, patients should avoid concomitant 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 the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt 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 medical care as needed.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include severe skin reactions such as hives, blisters, rash, skin reddening, and facial swelling. Additionally, allergic reactions have been noted, which may manifest as asthma (wheezing) and shock.

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 safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. They should stress that prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly enhance patient safety and outcomes.

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, ensuring that the storage environment does not exceed excessive heat above 40°C (104°F). Proper handling should be observed to maintain the integrity of the product during storage.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 gelcaps orally with water, repeating every 6 hours as needed, without exceeding 6 gelcaps in a 24-hour period. For children under 12 years, consultation with a healthcare professional is recommended prior to administration.

Clinicians should counsel patients on the importance of consulting 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 overdose, patients must seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)