Midol Complete

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 mentioned in the available data.

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, with a maximum limit of 6 caplets per day.

For children under 12 years of age, it is recommended to consult a healthcare professional before administration to determine the appropriate dosage.

It is imperative that patients do not exceed the recommended dose to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

Additionally, this product should not be used in individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse 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. Healthcare professionals should advise patients to adhere strictly to this dosage limit to mitigate the risk of hepatotoxicity.

Acetaminophen may also lead to severe skin reactions or allergic responses. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any of these symptoms, patients should discontinue use immediately and seek urgent medical assistance.

General precautions should be taken prior to use. Patients should consult a healthcare provider if they have a history of liver disease, glaucoma, urinary difficulties due to prostate enlargement, or respiratory conditions such as emphysema or chronic bronchitis. Additionally, it is advisable for patients to discuss their current medications with a healthcare professional, particularly if they are taking anticoagulants like warfarin or sedatives and tranquilizers, to avoid potential drug interactions.

In cases of overdose, immediate medical attention is essential. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of overt symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider 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 measures are crucial for ensuring patient safety and effective management of any adverse effects.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 6 caplets within 24 hours, particularly when combined with other medications containing acetaminophen or when consuming 3 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 any skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Participants are instructed to stop use and consult a healthcare professional if new symptoms arise, if redness or swelling is observed, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days.

Prior to 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 doctor. Additionally, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a healthcare provider or pharmacist before use.

While using this product, patients may experience drowsiness and should avoid alcoholic beverages, as well as be cautious when driving or operating machinery. Excitability may occur, particularly in children. The combination of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Furthermore, patients are 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.

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 this medication. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Midol Complete (acetaminophen, caffeine, 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 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 6 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information 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. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 prescribing information 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 the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product. It is important to note that severe liver damage may occur if the maximum daily amount of 6 caplets is exceeded within a 24-hour period. Additionally, patients should be aware that taking acetaminophen in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, the risk of liver damage is heightened for patients who consume three or more alcoholic drinks daily while using this product. Due to these risks, patients with known liver disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and 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 should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action 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 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. Reports include skin reddening, blisters, rash, hives, facial swelling, and asthma symptoms such as wheezing. Additionally, severe allergic reactions have been noted, which may manifest as 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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, 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 that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if they have a history of allergic reactions to it or any of its ingredients. Patients should be advised to discontinue use and consult a doctor if they experience new symptoms, or if they notice redness or swelling. Additionally, they should be informed to stop use and seek medical advice 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 be cautioned against consuming alcoholic beverages during its use. Excitability may also be a side effect, particularly in children. Furthermore, patients should be informed that the combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness, and they should exercise caution when driving or operating machinery.

Healthcare providers should recommend that patients 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.

Patients with liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or breathing problems such as emphysema or chronic bronchitis should be advised to consult a doctor before using this product. Additionally, patients taking the blood-thinning medication warfarin, as well as those on sedatives or tranquilizers, should be encouraged 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 for identification. It is essential to store the product at room temperature, ensuring that the storage environment does not exceed excessive heat above 40°C (104°F). Proper handling should be observed to maintain the integrity of the product during storage.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even in the absence of noticeable 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)