Menstrual Relief

Description

DG™ health Maximum Strength Menstrual Relief is formulated to provide multi-symptom relief for menstrual discomfort. Each caplet contains active ingredients including Acetaminophen, Caffeine, and Pyrilamine Maleate, which collectively function as a pain reliever, diuretic, and antihistamine. This product is indicated for the alleviation of cramps, bloating, fatigue, backache, and headache associated with menstrual cycles. The formulation is presented in a package containing 40 caplets. 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 distributor of this product is Dolgencorp, LLC, located at 100 Mission Ridge, Goodlettsville, TN 37072.

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 physician for appropriate dosing guidance.

Healthcare professionals should emphasize the importance of adhering to the recommended dosage and not exceeding the specified 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.

• In individuals with a history of allergic reactions 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 if not used according to the guidelines. Healthcare professionals should advise patients that the risk of liver damage increases with the following conditions: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

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

General precautions should be taken when considering this product for patients with specific health conditions. It is advisable to consult a healthcare provider prior to use in individuals who have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking anticoagulants like warfarin or those on sedatives or tranquilizers should seek guidance from a doctor or pharmacist before use.

In cases of accidental overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use 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

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic reactions. The product contains acetaminophen, which can lead to severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

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

Before using this product, patients should consult a doctor if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, it is recommended that patients discuss use with a healthcare provider if they are taking blood thinners like warfarin or sedatives and tranquilizers.

While using this product, patients should avoid alcoholic beverages, as they may exacerbate drowsiness, particularly when combined with sedatives or tranquilizers. Excitability may occur, especially in children, and patients should exercise caution when driving or operating machinery due to potential drowsiness. It is also advisable 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 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 medication if they are concurrently taking the anticoagulant warfarin. The combination may necessitate careful monitoring of coagulation parameters to avoid potential bleeding complications.

Additionally, caution is advised for individuals using sedatives or tranquilizers alongside this medication. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks that require alertness. Monitoring for increased sedation and potential dose adjustments may be warranted in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Menstrual Relief (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 prior to use. It is important to note that excitability may occur, particularly in children. Caution is advised when administering this medication to this age group.

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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 (1-800-222-1222) 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 apparent.

It is important to inform patients that this product should not be used 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 should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should also 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 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.

While using this product, patients should avoid consuming alcoholic beverages, as this may exacerbate side effects. They should be made aware that excitability may occur, particularly in children, and that the combination of this product with alcohol, sedatives, or tranquilizers may increase drowsiness. Patients should exercise caution when driving or operating machinery, as drowsiness may occur.

Patients should also be advised to limit their intake of caffeine-containing medications, foods, or beverages while using this product, 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 consult a doctor if they have difficulty urinating due to an enlarged prostate gland, liver disease, glaucoma, or any breathing problems such as emphysema or chronic bronchitis. Furthermore, patients taking the blood-thinning medication warfarin, or those on sedatives or tranquilizers, should seek advice from a healthcare professional or pharmacist prior to use.

Storage and Handling

The product is supplied with specific labeling that includes the expiration date and lot number, which can be found on the end flap of the packaging. It is essential to store the product at a controlled room temperature of 25ºC (77ºF). Temporary excursions from this temperature are permissible, provided they remain within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets orally with water every 6 hours as needed, without exceeding 6 caplets in a 24-hour period. For children under 12 years, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)