Midol Complete, Midol Complete, Travel Basix

Description

No description information is available for the drug.

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 instructed to take 2 caplets orally with water. This dosage may be repeated every 6 hours as needed, but the total daily intake must not exceed 6 caplets. For children under 12 years of age, it is essential to consult a healthcare professional before administration. It is imperative that patients adhere to the recommended dosage and not exceed 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.

• 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 following conditions are met: exceeding 6 caplets within a 24-hour period, using concurrently with other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

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

Healthcare professionals should advise patients to consult a physician prior to use 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. Additionally, 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.

In the case of an overdose, immediate medical attention is essential. Patients should be instructed to 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 noticeable symptoms.

Patients should also be advised 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.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 6 caplets within a 24-hour period, take this 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. 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 doctor. Additionally, those taking blood thinners like warfarin or sedatives and tranquilizers should seek advice from a healthcare professional prior to 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 enhance drowsiness. Patients are also advised to limit the 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 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 3 days.

Drug Interactions

Co-administration of acetaminophen with warfarin may elevate the risk of bleeding. It is recommended that International Normalized Ratio (INR) levels be monitored closely in patients receiving this combination to ensure safe therapeutic levels.

Concurrent use of alcohol, sedatives, and tranquilizers with this product may enhance drowsiness. It is advisable to avoid the simultaneous use of these substances to mitigate the risk of excessive sedation and related adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Midol Complete, Midol Complete, Travel Basix (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. 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 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 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, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended 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 associated with acetaminophen use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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. Early recognition and treatment can significantly influence outcomes, underscoring the importance of swift action in these scenarios.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data do not provide any details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

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 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, 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 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 whether a medication contains acetaminophen, they should consult a doctor or pharmacist for clarification. Additionally, patients should not use this product if they have a history of allergic reactions to it or any of its ingredients.

Patients should be instructed to stop using the product and consult a doctor if they experience new symptoms, or if they notice redness or swelling. They should also seek medical advice if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

While using this product, patients may experience drowsiness and should be cautioned against consuming alcoholic beverages, as this may exacerbate drowsiness. Excitability may occur, particularly in children, and patients should be aware that alcohol, sedatives, and tranquilizers can increase drowsiness. Caution should be exercised when driving or operating machinery.

Patients should limit their 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.

Before using this product, patients should 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. Furthermore, 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 the storage environment does not exceed temperatures of 40°C (104°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity 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 healthcare professional 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, and contacting a Poison Control Center is essential, as prompt medical attention is critical for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Midol Complete, Midol Complete, Travel Basix, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)