Comfort-Time

Description

The product is identified by the SPL code 34089-3 and is packaged in a tcl blister containing 24 tablets. An image of the carton is available for reference.

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, breast tenderness, fatigue, and muscle aches.

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

Dosage and Administration

For the temporary relief of symptoms associated with menstrual periods, including cramps, bloating, water-weight gain, headache, backache, breast tenderness, fatigue, and muscle aches, healthcare professionals should consider the appropriate dosage based on individual patient needs and symptom severity.

While specific details regarding the route, method, and frequency of administration are not provided, it is essential to follow standard practices for administering medications intended for symptom relief. Healthcare providers are advised to assess each patient's condition and tailor the dosage accordingly, ensuring that it aligns with established guidelines for safety and efficacy.

Patients should be monitored for response to treatment, and adjustments to the dosage may be necessary based on therapeutic outcomes and tolerability.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen, whether prescription or nonprescription. Consumption of three or more alcoholic drinks daily while using this product further elevates the risk of liver damage.

It is imperative that patients do not combine this product with any other acetaminophen-containing medications. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult with a healthcare provider or pharmacist for clarification.

Patients should be instructed to discontinue use and seek medical advice if they experience new symptoms, notice redness or swelling, or if pain worsens or persists beyond 10 days. These signs may indicate a need for further evaluation and management by a healthcare professional.

Emergency medical assistance should be sought if patients experience severe adverse reactions, although specific instructions for such situations are not provided in the current guidelines. Regular monitoring and patient education regarding the safe use of acetaminophen are essential to prevent potential complications.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly concerning liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within a 24-hour period, take it in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients are advised to stop use and consult a healthcare professional if new symptoms arise, if there is any redness or swelling, or if pain worsens or persists for more than 10 days.

Before using this product, patients should seek medical advice if they have a history of difficulty in urination due to prostate gland enlargement, liver disease, glaucoma, or any breathing problems such as emphysema or chronic bronchitis. Additionally, it is important for patients to consult a doctor or pharmacist if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers, as these may interact with the product.

Drug Interactions

Concurrent use of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional prior to using this product. The combination may enhance the anticoagulant effect, necessitating careful monitoring of INR levels.

Additionally, individuals using sedatives or tranquilizers are advised to seek guidance from a healthcare provider before initiating this product. The concomitant use of alcohol, sedatives, and tranquilizers may potentiate drowsiness, increasing the risk of sedation-related adverse effects.

Caution is also warranted regarding the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. It is advisable to limit caffeine intake to mitigate these potential effects.

Packaging & NDC

Below are the non-prescription pack sizes of Comfort-Time (acetaminophen, caffeine, and pyrilamine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients may experience excitability, which is particularly noted in children. It is important to ensure that the medication is kept out of reach of children to prevent accidental ingestion.

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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosage guidelines is essential to minimize the potential for adverse effects in this patient population. Regular monitoring of liver function tests may be warranted to ensure patient safety.

Overdosage

In the event of an overdosage, it is critical to recognize the potential for severe liver damage associated with this product, which contains acetaminophen.

Maximum Daily Dosage Healthcare professionals should advise patients that exceeding the maximum recommended dosage of 8 tablets within a 24-hour period significantly increases the risk of liver injury.

Concurrent Use with Other Acetaminophen Products Patients must be cautioned against the concurrent use of this product with other medications containing acetaminophen, as this can lead to cumulative dosing and heighten the risk of hepatotoxicity.

Alcohol Consumption Additionally, the consumption of three or more alcoholic drinks daily while using this product can exacerbate the risk of liver damage. It is essential to counsel patients on the dangers of combining acetaminophen with alcohol.

Recommended Actions In cases of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion.

Prompt recognition and intervention are crucial in mitigating the potential consequences of acetaminophen overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include drowsiness, excitability—particularly noted in children—nervousness, irritability, and sleeplessness. Additionally, rapid heartbeat has been observed.

Severe liver damage may occur if the product is taken in excess, in conjunction with other drugs containing acetaminophen, or with alcohol. Patients are advised to consult a doctor if new symptoms arise, including redness or swelling, or if pain worsens and persists for more than 10 days.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients should be informed to discontinue use and seek medical advice if they experience new symptoms, notice redness or swelling, or if their pain worsens or persists for more than 10 days.

It is important to communicate that this product may cause drowsiness; therefore, patients should avoid consuming alcoholic beverages while using it. Additionally, excitability may occur, particularly in children. Patients should be cautioned that alcohol, sedatives, and tranquilizers can enhance drowsiness. They should exercise caution when driving or operating machinery. Furthermore, patients should limit their intake of caffeine-containing medications, foods, or beverages while using this product, 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.

Healthcare providers should also advise patients to consult a doctor before using this product if they have difficulty urinating due to an enlarged prostate gland, have liver disease, glaucoma, or suffer from respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking the blood-thinning medication warfarin or those using 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 packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)