Menstrual Complete

Description

The product belongs to the Wellness™ family and contains three active ingredients: acetaminophen, a pain reliever; caffeine, a diuretic; and pyrilamine maleate, an antihistamine. It is formulated for multi-symptom relief, addressing cramps, bloating, fatigue, backache, and headache. The product is available in a dosage form of 16 caplets. The National Drug Code (NDC) is 55319-301-21. The packaging is tamper-evident, and it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is distributed by Midwood Brands LLC, located at 500 Volvo Parkway, Chesapeake, VA 23320, USA.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including bloating, headache, muscle aches, cramps, backache, fatigue, and water-weight gain.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and over are instructed 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 before administration.

Healthcare professionals should emphasize the importance of adhering to the prescribed dosage and not exceeding the recommended limits.

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, as such reactions may pose significant health risks.

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.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients should 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, respiratory issues such as emphysema or chronic bronchitis, or glaucoma. Additionally, patients taking anticoagulants such as warfarin or those on sedatives or tranquilizers should seek advice from a healthcare professional or pharmacist before using this product.

In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even if no symptoms are initially apparent.

Patients should be advised to discontinue use and consult 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. 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 other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, 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.

Common adverse reactions reported during the use of this product include drowsiness, which may be exacerbated by the consumption of alcoholic beverages, sedatives, or tranquilizers. Additionally, excitability has been noted, particularly in children. Patients are advised to exercise caution when driving or operating machinery due to the sedative effects.

Furthermore, it is recommended that patients limit the intake of caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. 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 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, as these may indicate a serious condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking any of the following medications or substances:

Anticoagulants

• Warfarin: The use of this product in conjunction with warfarin may necessitate careful monitoring due to potential alterations in anticoagulation effects.

CNS Depressants

• Sedatives and Tranquilizers: Concurrent use may enhance the sedative effects, leading to increased drowsiness. Monitoring for excessive sedation is advised.

Alcohol

• The combination of alcohol with this product may also amplify drowsiness. Caution is recommended when consuming alcohol during treatment.

Caffeine

• Patients are advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may result in adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. Monitoring for these symptoms is suggested.

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 aged 12 years and older, the recommended dosage is 2 caplets taken with water, which may be repeated every 6 hours as needed, without exceeding 6 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, it is essential to seek prompt medical attention for both adults and pediatric patients, even if no signs or symptoms are immediately 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. It is important to assess the potential risks and benefits associated with its 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 drug 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use of other medications containing acetaminophen should be avoided to prevent unintentional overdose.

• Consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may significantly increase the risk of liver damage.

Additionally, patients with known liver disease are advised to consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an 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, 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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical 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 be encouraged to consult a doctor or pharmacist.

It is essential 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 pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, as these may indicate a serious condition.

Patients should be made aware that drowsiness may occur while using this product. They should be cautioned to avoid alcoholic beverages, as well as to be mindful that alcohol, sedatives, and tranquilizers can enhance drowsiness. Furthermore, patients should be informed that excitability may occur, particularly in children.

When using this product, patients should exercise caution when driving or operating machinery. They 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 heart rate. It is important to note that the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients should be encouraged to consult a doctor before using this product if they have difficulty urinating due to an enlarged prostate gland, liver disease, or breathing problems such as emphysema or chronic bronchitis. Additionally, patients with glaucoma should seek medical advice prior to use. Those taking the blood-thinning medication warfarin, as well as individuals using sedatives or tranquilizers, should also consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to refrain from using the product if the outer package is opened or if the blister is torn or broken. Healthcare professionals should check the end flap for the expiration date and lot number to ensure product integrity.

For optimal storage, the product should be maintained at a temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15°C to 30°C (59°F to 86°F). Proper handling and storage conditions are crucial to preserve the product's efficacy and safety.

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 important to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

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.

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