Midol Complete

Description

Midol ® is a combination product containing acetaminophen, caffeine, and pyrilamine maleate. It is classified as a pain reliever, diuretic, and antihistamine. Manufactured by BAYER, Midol ® is indicated for the multi-symptom relief of cramps, bloating, fatigue, headache, and backache. The dosage form consists of two caplets.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including cramps, bloating, water-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 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 healthcare professional prior to administration to determine the appropriate dosage.

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 significant risk of severe liver damage if not used according to the specified guidelines. Healthcare professionals should advise patients to adhere strictly to the following precautions to mitigate this risk:

Liver Warning Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, the risk increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product. It is essential to monitor liver function in patients who may be at risk due to these factors.

Allergy Alert Acetaminophen may induce severe skin reactions or allergic responses. Symptoms indicative of such reactions can include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Stop Use and Consult a Doctor If Patients should be advised to stop using the product and consult a healthcare professional if they experience new symptoms, if redness or swelling occurs, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days. Monitoring for these symptoms is crucial to ensure patient safety.

In Case of Overdose In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent. Healthcare providers should emphasize the importance of immediate action in such situations.

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 that acetaminophen may lead to severe skin or allergic reactions, which can manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. Individuals with a history of allergic reactions to this product or any of its ingredients should not use it.

Before using this product, patients with liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or breathing problems such as emphysema or chronic bronchitis should consult a healthcare professional. Additionally, those taking blood thinners like warfarin or sedatives and tranquilizers should seek advice from a doctor or pharmacist prior to use.

While using this product, patients may experience drowsiness and should avoid alcoholic beverages. Excitability may occur, particularly in children. The combination of alcohol, sedatives, and tranquilizers can enhance drowsiness, necessitating caution when driving or operating machinery. Patients are also advised 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 intensifies or lasts more than three days. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring due to potential alterations in anticoagulant effects.

Additionally, individuals using sedatives or tranquilizers should seek advice from a healthcare provider before initiating treatment. 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 is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Midol Complete (acetaminophen, caffeine, and pyrilamine maleate tablet). 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. Careful monitoring is advised when administering this medication to pediatric populations.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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. Therefore, 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. The maximum recommended dosage is 6 caplets in a 24-hour period. Exceeding this dosage, using other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in these patients to ensure safety and to mitigate the risk of 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 essential for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are crucial 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

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, asthma (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, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Patients should be encouraged to consult with their healthcare provider before using this product if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or breathing problems such as emphysema or chronic bronchitis. Additionally, it is important for patients to inform their doctor or pharmacist if they are taking the blood-thinning medication warfarin, or if they are using sedatives or tranquilizers.

While using this product, patients may experience drowsiness and should be cautioned to avoid alcoholic beverages, as alcohol can enhance drowsiness. Healthcare providers should also inform patients that excitability may occur, particularly in children. Patients should exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Furthermore, 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. It is important to note that the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

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 to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 caplets 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 overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is essential for both adults and children, even in the absence 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)