Menstrual Pain Relief Complete

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including cramps, bloating, water retention, weight gain, headache, backache, muscle aches, and fatigue.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets with water. Dosing may be repeated every 6 hours as needed, but the total daily dosage must not exceed 6 caplets. For children under 12 years of age, it is recommended to consult a physician before administration.

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

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. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

Patients should be advised to stop using the product and consult a healthcare professional if new symptoms arise, particularly if redness or swelling is observed. Furthermore, if pain persists or worsens beyond 10 days, or if fever intensifies or lasts more than 3 days, these may be indicative of a serious underlying condition requiring medical evaluation.

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

Side Effects

Severe liver damage may occur in patients who 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 aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and in rare cases, shock.

It is advised that patients discontinue use and consult a healthcare professional if new symptoms arise, particularly if redness or swelling is present, 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 attention.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Pain Relief Complete (acetaminophen, pyrilamine maleate, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years should consult a healthcare professional before use. In pediatric patients, excitability may occur, particularly in younger children. It is essential for both adults and children to seek prompt medical attention, even in the absence of noticeable signs or symptoms. For adolescents 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.

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 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 the safety of both the mother and the developing fetus or nursing infant.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential for patients with hepatic impairment to minimize the risk of adverse effects. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of acetaminophen overdosage, severe liver damage may occur if an individual ingests more than 4,000 mg within a 24-hour period. This threshold is critical, as exceeding it significantly increases the risk of hepatotoxicity.

Healthcare professionals are advised to seek emergency medical assistance immediately if an overdose is suspected or if the patient exhibits severe symptoms. Prompt intervention is essential to mitigate potential complications associated with acetaminophen overdosage.

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 safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include severe skin reactions such as skin reddening, blisters, rash, hives, and facial swelling. Additionally, instances of asthma, characterized by wheezing, have been reported.

In cases of severe skin reactions, it is advised that patients discontinue use of the product and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially present.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, they should not 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.

Patients should be informed to discontinue use and consult a doctor if they experience new symptoms, redness or swelling, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than 3 days, as these may indicate a serious condition. It is also important to advise patients to avoid alcoholic beverages while using this product.

Healthcare providers should make patients aware that excitability may occur, particularly in children, and they should exercise caution when driving or operating machinery, as drowsiness may result from the use of this product. The combination of alcohol, sedatives, and tranquilizers can further increase drowsiness.

Patients should be informed that they may experience drowsiness and should limit their intake of caffeine-containing medications, foods, or beverages while taking this product, as excessive caffeine can lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Finally, patients should be advised to consult a doctor before using this product if they have difficulty urinating due to an enlarged prostate gland, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. They should also seek guidance from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or are using sedatives or tranquilizers.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25ºC (77ºF). Temporary excursions are permissible between 15ºC and 30ºC (59ºF to 86ºF).

Care should be taken to ensure that the product is kept in its original container to maintain stability and integrity. Special handling requirements include protecting the product from excessive heat and moisture.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Menstrual Pain Relief Complete, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)