Menstrual Pain Relief 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 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 a full glass of water. This dosage may be repeated every 6 hours as needed. It is imperative that patients do not exceed a total of 6 caplets in a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to the 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

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury 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 beverages daily while using this product.

Patients should be made aware of the potential for severe allergic reactions associated with acetaminophen. 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 discontinue use immediately and seek medical assistance.

In cases of suspected 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.

Healthcare professionals should instruct patients to discontinue use and consult a physician if new symptoms arise, particularly if redness or swelling is observed, if pain intensifies or persists beyond 10 days, or if fever worsens 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 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 of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and in some 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 three days. These symptoms may indicate a serious underlying condition that requires medical attention.

Drug Interactions

There are currently no documented drug interactions or interactions with laboratory tests associated with this medication. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time. Healthcare professionals should continue to assess individual patient circumstances and consider any potential interactions based on the patient's overall medication regimen.

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

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 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 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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential risk of severe liver damage associated with the use of this product, which contains acetaminophen. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients must avoid the concurrent use of other medications that contain acetaminophen to mitigate the risk of hepatotoxicity.

Furthermore, patients with compromised liver function should be advised against the consumption of three or more alcoholic drinks daily while using this product, as this may significantly increase the likelihood of liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. This risk is compounded when acetaminophen is taken concurrently with other medications that also contain acetaminophen, as this can lead to cumulative dosing that exceeds safe limits.

Additionally, the risk of severe liver damage is heightened in individuals who consume three or more alcoholic drinks daily while using acetaminophen. The interaction between alcohol and acetaminophen can exacerbate hepatotoxicity, leading to potentially life-threatening liver injury.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should assess the patient's clinical status and consider the need for laboratory tests to evaluate liver function. Prompt intervention may include the administration of N-acetylcysteine (NAC), which is an effective antidote for acetaminophen toxicity, particularly when given within 8 to 10 hours of ingestion.

Monitoring and supportive care should be instituted as necessary, depending on the severity of the symptoms and the extent of liver damage. It is crucial for healthcare professionals to remain vigilant regarding the signs and symptoms of liver injury, which may include nausea, vomiting, abdominal pain, and jaundice.

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 identified several adverse reactions associated with the use of the product. Notable among these are severe skin reactions, which include 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 apparent.

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, or if redness or swelling occurs. They should also be advised to stop use and seek medical advice if pain worsens or persists for more than 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 alcohol may exacerbate drowsiness. They should be made aware that excitability may occur, particularly in children, and that caution is advised when driving or operating machinery due to the potential for drowsiness. Furthermore, patients should be informed that the use of alcohol, sedatives, and tranquilizers may increase drowsiness when using this product.

Patients should limit their 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. It is important to note that the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Healthcare providers should encourage patients 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 on sedatives or tranquilizers, should be advised to seek guidance from a doctor or pharmacist prior to use.

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 permitted 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 avoiding exposure to extreme temperatures and protecting the product from 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)