Menstrual Complete

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 cramps, 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 of age or 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

Use of this product is contraindicated in the following situations:

Patients should avoid alcoholic beverages, as the combination may enhance drowsiness. The concurrent use of alcohol, sedatives, and tranquilizers is also discouraged due to the potential for increased sedation. Caution is advised when driving or operating machinery, as drowsiness may impair performance. Additionally, the use of caffeine-containing medications, foods, or beverages should be limited, as excessive caffeine intake can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 6 caplets within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin or allergic reactions. Symptoms indicative of such reactions can include skin reddening, blistering, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients must discontinue use immediately and seek medical assistance.

It is imperative that this product not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Healthcare professionals should encourage patients to verify the presence of acetaminophen in any other medications they may be taking.

Patients should consult with a healthcare provider or pharmacist if they have a history of allergic reactions to this product or any of its components.

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 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 caplets within a 24-hour period, take the 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 skin reddening, blistering, rash, hives, 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.

Patients are instructed to stop use and consult a healthcare professional if new symptoms arise, if redness or swelling is observed, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than three days.

Prior to using this product, patients should consult a doctor if they have liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or a breathing problem such as emphysema or chronic bronchitis. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before use.

Drug Interactions

Acetaminophen has the potential to elevate the risk of severe liver damage when used concurrently with other medications containing acetaminophen or when consumed alongside three or more alcoholic beverages daily. It is advisable for healthcare providers to counsel patients on the importance of adhering to recommended dosages and to avoid combining multiple sources of acetaminophen.

Caffeine may enhance drowsiness when administered with sedatives or tranquilizers. Patients should be advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery, during such combinations.

Warfarin, an anticoagulant, may experience altered effects when taken with acetaminophen. It is recommended that healthcare professionals monitor International Normalized Ratio (INR) levels in patients receiving this combination to ensure therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Complete (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 and adults aged 12 years and older, the recommended dosage is 2 caplets taken with water, which may be repeated every 6 hours as needed, with a maximum of 6 caplets per day.

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

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 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosage guidelines is essential to minimize the potential for adverse effects in this patient population.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with any medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

Management of an overdose typically involves supportive care, which may include the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

3. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or additional management strategies, if applicable.

It is crucial for healthcare professionals to document the incident thoroughly and report any adverse events to the appropriate regulatory authorities. Continuous education on the signs of overdose and the importance of prompt intervention can significantly improve patient outcomes in such scenarios.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience new symptoms, or if they notice any redness or swelling. Additionally, they should 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.

It is important to inform patients that this product may cause drowsiness. They should be cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness. Patients should also be careful when driving or operating machinery due to the potential for impaired alertness.

Patients should limit their 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 healthcare provider if they have liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing problems such as emphysema or chronic bronchitis. Furthermore, patients taking the blood-thinning medication warfarin, or those using sedatives or tranquilizers, should also seek advice from a healthcare professional 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 noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)