Xl-3 Day Time

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dosing cup provided with the product to ensure accurate measurement. The dosing cup should be kept with the product at all times.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (equivalent to 2 tablespoons) every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL (equivalent to 1 tablespoon) every 4 hours.

For children aged 4 to under 6 years, it is advised to consult a physician before administration. The product is not recommended for use in children under 4 years of age.

Healthcare professionals should instruct patients not to exceed 4 doses within a 24-hour period. If the Day Time formulation is taken during the day and the Night Time formulation is used at night, the total combined doses should still not exceed 4 doses in a 24-hour timeframe.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other products containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Use for pain exceeding 10 days without medical supervision is contraindicated, as prolonged use may lead to adverse effects.

• Use for fever beyond 3 days without medical guidance is contraindicated, as extended use may mask underlying conditions.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated, as this may lead to serious interactions. This includes MAOIs used for depression, psychiatric or emotional conditions, or Parkinson's disease, and extends for 2 weeks after discontinuation of MAOIs. If there is uncertainty regarding the presence of an MAOI in a prescription, consult a healthcare professional.

• Use should not exceed the directed dosage, and caution is advised to prevent overdose.

• Consumption of alcoholic beverages while using this product is contraindicated due to the potential for increased risk of liver damage.

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 an adult exceeds 5 doses within a 24-hour period, combines this product with other medications containing acetaminophen, or consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

Patients should be advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms worsen or persist beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical advice should be sought. The presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache warrant immediate medical evaluation, as these may indicate a serious condition.

In the event of a skin reaction, it is critical to stop use and seek emergency medical help without delay.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if an adult takes more than five doses in 24 hours, uses this product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product. In the event of an overdose, which is defined as taking more than the recommended dose, serious health problems, including liver damage, may arise. Patients should seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) if an accidental overdose occurs, as prompt medical attention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should also be vigilant for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical help immediately. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include nervousness, dizziness, sleeplessness, worsening symptoms lasting more than five days in children or seven days in adults, fever lasting more than three days, presence of redness or swelling, occurrence of new symptoms, or a cough that returns or occurs with a rash or headache lasting. These may indicate a serious condition.

Patients are advised to consult a doctor before using this product if they have liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, a cough accompanied by excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Furthermore, it is recommended that patients consult a doctor or pharmacist before use if they are taking the blood-thinning medication warfarin.

Drug Interactions

Patients taking acetaminophen should consult with a healthcare professional prior to use if they are concurrently using warfarin, a blood-thinning medication. Acetaminophen may influence International Normalized Ratio (INR) levels, which could affect the anticoagulant's efficacy and safety. Monitoring of INR levels is advised in patients receiving both acetaminophen and warfarin to ensure appropriate therapeutic management.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Xl-3 Day Time (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL (1 tablespoon) every 4 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the general considerations 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 mothers.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur under certain conditions, including the ingestion of more than five doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, it is recommended that patients with compromised liver function limit their intake of acetaminophen and consult with a healthcare professional for appropriate dosing adjustments and monitoring strategies. Regular assessment of liver function may be warranted to ensure patient safety and to mitigate the risk of adverse effects.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, serious health complications may arise, including potential liver damage. It is imperative that healthcare professionals remain vigilant regarding the risks associated with overdosing.

Recommended Actions In the case of an accidental overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. This step is crucial for ensuring appropriate management and intervention.

Symptoms and Management Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly mitigate the risk of severe health consequences. Healthcare professionals should be prepared to assess the patient's condition and initiate necessary treatment protocols based on the severity of the overdose and the specific clinical presentation.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately, and medical assistance should be sought without delay.

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 containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be informed that this product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. It is important to caution patients against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to seek clarification from a doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and seek medical advice if their symptoms worsen or persist beyond 5 days for children or 7 days for adults. If a fever worsens or lasts more than 3 days, or if there is any redness or swelling, patients should be directed to stop use and contact a healthcare professional. New symptoms or a cough that returns or occurs with a rash or persistent headache should also prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dosage and to avoid consuming alcoholic beverages. It is essential for patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough accompanied by excessive phlegm or a persistent or chronic cough associated with smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product.

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 within a temperature range of 58º to 86ºF (15º to 30ºC) to maintain its efficacy and integrity. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Xl-3 Day Time, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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