Menstrual Complete

Description

+TopCare® health is a menstrual complete product formulated to provide multi-symptom relief. It contains active ingredients including acetaminophen, caffeine, and pyrilamine maleate, which function as a pain reliever, diuretic, and antihistamine, respectively. This formulation addresses symptoms such as cramps, headache, bloating, backache, and fatigue.

The product is available in a package size of 24 caplets. It is important to note the tamper evident warning: do not use if the imprinted safety seal under the cap is broken or missing. The product is distributed by Topco Associates LLC, located in Itasca, IL 60143, and is not manufactured or distributed by Bayer HealthCare LLC, the owner of the registered trademark Midol® Complete. Quality is guaranteed. The National Drug Code (NDC) for this product is 36800-391-08.

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 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 for appropriate dosing guidance.

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 individuals with a history of allergic reactions to this product or any of its ingredients. Additionally, it should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

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 also warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or 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. Healthcare providers should recommend that patients consult a physician prior to use if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking anticoagulants like 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 signs or symptoms are initially apparent.

Patients should be advised to discontinue use and consult a physician 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 medical 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 in conjunction 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 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.

Participants in clinical trials and postmarketing experiences have indicated that drowsiness and excitability, particularly in children, may occur during the use of this product. Caution is advised when driving or operating machinery, as the use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Additionally, patients are advised to limit caffeine intake while using this product, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate.

Patients should stop using this product 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.

Before using this product, patients with difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or breathing problems such as emphysema or chronic bronchitis should consult a doctor. Additionally, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a healthcare provider or pharmacist prior to use.

This product should not be used by individuals who have previously experienced an allergic reaction to it or any of its ingredients, nor should it be combined with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients are encouraged to consult a doctor or pharmacist.

Drug Interactions

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

Additionally, individuals using sedatives or tranquilizers should seek advice from a healthcare provider before use. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness.

Caution is advised regarding the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. Monitoring of caffeine intake is recommended to mitigate these potential effects.

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

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 adverse effects or changes in therapeutic response, 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 lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 drug 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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before initiating treatment. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function 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 daily 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 to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, regardless of whether they observe any signs or symptoms. It is crucial for both adults and children to receive prompt medical attention in such situations to ensure their safety and well-being.

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.

For optimal storage, the product should be maintained at a temperature of 25°C (77°F). However, temporary excursions are permissible within the range of 15°C to 30°C (59°F to 86°F). It is essential to ensure that the product is stored in a suitable container to maintain its integrity and efficacy. Special handling requirements should be observed to prevent any compromise of the product's quality.

Additional Clinical Information

Patients should be informed that 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 for appropriate dosing.

Clinicians should counsel patients about potential side effects, including drowsiness and excitability, particularly in children. Caution is advised when driving or operating machinery. Patients should avoid alcohol, sedatives, and tranquilizers, as these may enhance drowsiness. Additionally, it is recommended to limit the intake of caffeine-containing products, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and occasionally rapid heart rate.

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)