Menstrual Complete

Description

NDC 50844-390-21. This product contains a combination of Acetaminophen, Caffeine, and Pyrilamine maleate, functioning as a pain reliever, diuretic, and antihistamine. It is indicated for the multi-symptom relief of cramps, bloating, fatigue, backache, and headache. The formulation is provided in a dosage form of 16 caplets. The packaging is tamper evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. Distributed by LNK International, Inc., located at 60 Arkay Drive, Hauppauge, NY 11788, USA.

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 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 doctor before administration. Healthcare professionals should ensure that patients adhere to the recommended dosing guidelines to avoid potential overdose.

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.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

• Consumption of alcoholic beverages is contraindicated while using this product, as it may increase the risk of adverse effects.

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 lead to 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 using this product 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, patients taking anticoagulants such as warfarin or those on sedatives or tranquilizers should seek advice from a healthcare professional or pharmacist before use.

In cases of accidental overdose, it is imperative to obtain 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 advised to discontinue use and consult a physician if they experience new symptoms, notice redness or swelling, find that 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 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, patients are advised to discontinue use and seek medical assistance immediately.

Patients should 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 three days, as these may indicate a serious condition.

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

While using this product, patients are advised to avoid alcoholic beverages, as excitability may occur, particularly in children. Caution is recommended when driving or operating machinery due to the potential for drowsiness, which may be exacerbated by alcohol, sedatives, and tranquilizers. 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 heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

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 heartbeat. Monitoring of caffeine intake is recommended to avoid these potential side effects.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Complete (acetaminophen, caffeine and 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. There is a potential for excitability, particularly in children. 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 a total of 6 caplets in one day.

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 potential 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. 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 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 have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, 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. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In the event of an accidental 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 early intervention can significantly impact the outcome of an overdose situation. Therefore, it is essential to remain vigilant and proactive in managing potential overdose cases.

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 in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 in the event of an accidental overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

It is important to inform patients that they should not 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 consult a healthcare professional.

Patients must be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to discontinue use and consult a doctor if they experience new symptoms, or if they notice redness or swelling. Additionally, patients should stop using the product and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days, as these may indicate a serious condition.

While using this product, patients should be advised to avoid alcoholic beverages, as alcohol may exacerbate side effects. They should also be made aware that excitability may occur, particularly in children, and that caution is warranted when driving or operating machinery due to the potential for drowsiness.

Patients should be informed that the use of alcohol, sedatives, and tranquilizers in conjunction with this product may increase drowsiness. Furthermore, they should limit their intake of caffeine-containing medications, foods, or beverages, as excessive caffeine can 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.

Before using this product, patients should be encouraged to consult a doctor 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 healthcare professional prior to use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which can be found on the packaging. Healthcare professionals are advised to check the end flap for the expiration date and lot number to ensure product integrity.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF). However, excursions are permitted within a range of 15ºC to 30ºC (59ºF to 86ºF). It is essential to handle the product with care, as it is tamper evident; therefore, it should not be used if the outer package is opened or if the blister is torn or broken.

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 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)