Menstrual Complete

Description

This product is a multi-symptom relief formulation containing acetaminophen, caffeine, and pyrilamine maleate as active ingredients. It is classified as a pain reliever, diuretic, and antihistamine. The product is indicated for the relief of cramps, bloating, fatigue, backache, and headache. Each package contains 24 caplets. The product is distributed by LNK International, Inc., located at 60 Arkay Drive, Hauppauge, NY 11788, USA. 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 50844-399-08.

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 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

This product contains acetaminophen, which carries a significant risk of severe liver damage. Healthcare professionals should advise patients that liver damage may occur 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 drinks daily while using this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

General precautions should be taken when considering this product. Patients should consult a healthcare provider prior to use if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, liver disease, respiratory issues such as emphysema or chronic bronchitis, or glaucoma. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are currently taking blood thinners, such as warfarin, or sedatives and tranquilizers.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should also be advised to stop taking the 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. 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. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients should discontinue use and seek medical assistance immediately.

Patients are advised to stop using this product 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 3 days, as these may indicate a serious condition.

While using this product, drowsiness may occur, and patients should avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Excitability may also be experienced, particularly in children. Caution is recommended when driving or operating machinery. Furthermore, patients should 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 consult a doctor prior to use if they have difficulty urinating due to prostate gland enlargement, liver disease, respiratory issues such as emphysema or chronic bronchitis, or glaucoma. Additionally, it is advisable to seek guidance from a healthcare professional if taking the blood-thinning medication warfarin or if using sedatives or tranquilizers.

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 symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heart rate. Monitoring for these effects 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, 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 prompt medical attention for both adults and children, 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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, as liver function may influence renal clearance and overall drug metabolism. Monitoring and appropriate dosing adjustments may be necessary for patients 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 with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver damage.

Additionally, patients with a known history of liver disease should 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed that acetaminophen may cause severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

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 whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is essential to instruct patients not to use this product if they have a history of allergic reactions to it or any of its ingredients. Patients should be advised to discontinue use and consult a doctor if they experience new symptoms, or if they notice redness or swelling. Additionally, they should seek medical advice 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 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, breathing problems such as emphysema or chronic bronchitis, or glaucoma. 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 inventory management and product 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.

View product document (PDF)