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 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 for appropriate dosing guidance.

Healthcare professionals should emphasize to patients 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:

• Co-administration with any other drug 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.

• History of allergic reaction to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must 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 anticoagulants such as warfarin or those on sedatives or tranquilizers should be advised to consult a doctor or pharmacist before using this product.

In cases of overdose, it is imperative to seek emergency medical help or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even if no immediate signs or symptoms are apparent.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience new symptoms, redness or swelling, worsening pain lasting more than 10 days, or a fever that persists or worsens beyond three 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 a 24-hour period, 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.

While using this product, drowsiness may occur, and patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Additionally, excitability may be observed, particularly in children. Caution is recommended 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 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 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.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication 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 that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 attention 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 adverse effects. Therefore, vigilance and timely intervention are essential in managing overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has been gathered through voluntary reports and surveillance programs. Healthcare professionals and patients are encouraged to report any undesired reactions or side effects associated with the use of the product. For inquiries or to report such events, individuals may contact 1-888-1915.

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 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 be advised 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 heart rate. 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, glaucoma, or any breathing problems such as emphysema or chronic bronchitis. Additionally, patients taking the blood-thinning medication warfarin, or those using sedatives or tranquilizers, should seek advice from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage. Special handling requirements are not specified; however, adherence to the recommended storage conditions is essential for maintaining product integrity.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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)