Midol Complete

Description

Midol® COMPLETE is a combination medication containing Acetaminophen, Caffeine, and Pyrilamine Maleate, formulated to provide multi-symptom relief. This product serves as a pain reliever, diuretic, and antihistamine, addressing symptoms such as cramps, bloating, fatigue, headache, and backache. Each package contains two caplets, designed for single-use.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years and older are instructed to take 2 caplets with water. This dosage may be repeated every 6 hours as needed, with a maximum limit of 6 caplets per day.

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

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 poses a risk of severe liver damage if the maximum daily dosage of 6 caplets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the individual consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin or allergic reactions. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to using this product if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, patients should be cautioned to seek guidance from a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives/tranquilizers.

Emergency Medical Help In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation of Use Patients should be instructed to stop using this product and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six caplets within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use and seek medical assistance immediately.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

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

While using this product, patients may experience drowsiness and should avoid alcoholic beverages, as well as be cautious of increased drowsiness when combined with sedatives or tranquilizers. Excitability may occur, particularly in children. Patients are advised to exercise caution when driving or operating machinery. Furthermore, it is recommended 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.

Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 10 days, or if fever worsens or lasts more than 3 days.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. The combination may enhance the effects of warfarin, increasing the risk of bleeding.

Additionally, the concurrent use of alcohol, sedatives, or tranquilizers may potentiate drowsiness. Caution is advised, and patients should be monitored for increased sedation and impairment of motor skills when these substances are used together.

Packaging & NDC

Below are the non-prescription pack sizes of Midol 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. For 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. Caution is advised as excitability may occur, particularly in pediatric patients.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient 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

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 patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that severe liver damage may occur if the maximum daily dosage of 6 caplets is exceeded within a 24-hour period. Additionally, the risk of severe liver damage is heightened when this product is taken concurrently with other medications containing acetaminophen.

Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Therefore, careful consideration and monitoring of liver function are advised for patients with compromised liver function to prevent potential adverse effects.

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 observable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. The lack of immediate symptoms does not preclude the possibility of serious health consequences, and therefore, timely evaluation and treatment are essential.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions and severe allergic reactions. Reported symptoms include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of a skin or general allergic reaction, it is advised to discontinue use immediately and seek medical assistance.

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 must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial 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 about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist for clarification.

It is essential to instruct patients to discontinue use and consult a doctor if they experience new symptoms, or if redness or swelling occurs. Additionally, patients should be advised to stop using the product if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

Patients should be made aware that drowsiness may occur while using this product, and they should avoid alcoholic beverages during its use. Excitability may also be a side effect, particularly in children. Furthermore, patients should be cautioned that the combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness, and they should exercise caution when driving or operating machinery.

Patients 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 liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, 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 seek advice from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that temperatures do not exceed 25°C (77°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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, consultation with a doctor is advised prior to use.

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 overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, 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 Midol Complete, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)