Menstrual Complete

Description

Meijer Maximum Strength Menstrual Complete is formulated to provide multi-symptom relief from cramps, bloating, fatigue, backache, and headache. Each caplet contains a combination of active ingredients, including acetaminophen, caffeine, and pyrilamine maleate. The product is packaged in a bottle containing 40 caplets.

A tamper evident warning is included, stating that the product should not be used if the imprinted safety seal under the cap is broken or missing. The National Drug Code (NDC) for this product is 41250-390-10. It is distributed by Meijer Distribution, Inc., located in Grand Rapids, MI 49544. This product is not manufactured or distributed by Bayer HealthCare LLC, the owner of the registered trademark Midol Complete. For more information, visit www.meijer.com.

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 advised 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 recommended dosage and not exceeding the specified limits.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

This product should not be used in individuals with a known history of allergic reactions to this product or any of its ingredients.

Additionally, while using this product, the consumption of alcoholic beverages is contraindicated, as alcohol may exacerbate drowsiness. The concomitant use of alcohol, sedatives, and tranquilizers is also discouraged due to the potential for increased sedation.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should exercise caution and recommend that patients consult a physician prior to use if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking blood thinners, such as warfarin, or those on sedatives or tranquilizers should also seek advice from a healthcare professional or pharmacist before using this product.

In cases of accidental overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical attention is crucial for both adults and children, even if no immediate signs or symptoms are 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 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.

Participants are advised to stop 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, as these may indicate a serious condition.

While using this product, patients should avoid alcoholic beverages, as they may exacerbate drowsiness, particularly when combined with sedatives or tranquilizers. Excitability may occur, especially in children, and caution is advised when driving or operating machinery. Additionally, patients are encouraged 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. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients should consult a healthcare provider 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. Furthermore, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

In cases of accidental overdose, it is crucial to obtain medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects.

Concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness. It is advisable for patients to exercise caution when engaging in activities that require alertness, such as driving or operating machinery, and to consider dosage adjustments or monitoring for increased sedation 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 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, without exceeding 6 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an accidental overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both children and adults, 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.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, if used concurrently with other products containing acetaminophen, or if the patient consumes three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of overdose cases may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to conduct a thorough assessment and provide appropriate interventions based on the patient's condition and the guidance of poison control experts.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 accidental overdose. It is crucial to obtain prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be cautioned against the consumption of alcoholic beverages while using this product, as it may exacerbate drowsiness. Healthcare providers should inform patients that excitability may occur, particularly in children, and that they should exercise caution when driving or operating machinery due to the potential for drowsiness.

Additionally, patients should be made aware that the use of alcohol, sedatives, and tranquilizers can further increase drowsiness. It is important to limit the intake of caffeine-containing medications, foods, or beverages while taking this product, 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.

Storage and Handling

The product is supplied with specific labeling that includes the expiration date and lot number, which can be found on the end flap of the packaging. It is essential to store the product at a controlled room temperature of 25°C (77°F). Temporary excursions from this temperature are permissible, provided they remain within the range of 15°C to 30°C (59°F to 86°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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 accidental overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical 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.

View product document (PDF)