Xl-3 Day Time

Description

XL-3 Day Time is a cold medicine formulated to provide fast relief from nasal congestion, fever, aches and pains, sore throat, and cough. The product contains three active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant.

The formulation is presented in a liquid dosage form with an orange flavor, available in a volume of 12 fluid ounces (354 mL). Inactive ingredients include citric acid, FD & C Yellow No. 6, flavoring agents, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose.

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

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

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

Healthcare professionals should instruct patients to utilize a dose cup or tablespoon for accurate measurement. It is important to note that the total number of doses should not exceed 4 doses within a 24-hour period. If the patient is taking both Day Time and Night Time formulations, the combined total of doses from both products must also be limited to 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.

• Use for more than 10 days for pain, unless directed by a healthcare professional, to prevent potential adverse effects associated with prolonged use.

• Use for more than 3 days for fever, unless directed by a healthcare professional, to mitigate the risk of masking underlying conditions.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs, as this may lead to serious drug interactions.

• Exceeding the recommended dosage, as indicated in the overdose warning, is contraindicated.

• Consumption of alcoholic beverages while using this product should be avoided to reduce the risk of liver damage and other adverse effects.

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 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than 5 doses in 24 hours, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic beverages 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, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, it is imperative that patients consult a healthcare provider without delay.

Patients should be advised to stop use and seek medical advice 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 consultation is necessary. 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 underlying condition.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur if an adult takes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in the same timeframe, if the product is used concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic drinks daily while using this product. In cases of accidental overdose, which may lead to serious health issues including liver damage, it is crucial to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222), even if no symptoms are apparent.

Patients should also be alert 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.

In addition, patients are advised to consult a doctor if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should stop use and consult a healthcare professional if symptoms worsen or last longer than five days in children or seven days in adults, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These could indicate a serious underlying condition.

Patients with pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or urinary issues due to an enlarged prostate gland should seek medical advice before using this product. Additionally, those experiencing a cough with excessive phlegm or a persistent cough, such as that associated with smoking, asthma, or emphysema, should also consult a healthcare provider prior to use.

Finally, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of MAOI therapy, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe use and to mitigate the risk of potential interactions that could affect bleeding risk.

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 doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the liver warning associated with this medication; severe liver damage may occur if a child exceeds 5 doses within a 24-hour period. Additionally, caregivers should be instructed to stop use and consult a doctor if symptoms worsen or persist for more than 5 days. A fever warning is also applicable; if a child's fever worsens or lasts longer than 3 days, medical advice should be sought.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older, due to the increased likelihood of comorbidities. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or urinary difficulties related to an enlarged prostate gland.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional or pharmacist before using this product, as potential interactions may occur.

Given that this product contains acetaminophen, it is critical to adhere to the recommended dosage guidelines. Severe liver damage may result from exceeding 4,000 mg of acetaminophen within a 24-hour period. Elderly patients are particularly advised to avoid the consumption of alcoholic beverages while using this product, as this may exacerbate the risk of liver injury.

Patients should discontinue use and consult a healthcare provider if they experience symptoms such as nervousness, dizziness, or insomnia. Furthermore, prompt medical attention is essential for all adults, including elderly patients, in the event of an accidental overdose, even if no immediate signs or symptoms are present.

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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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. Severe liver damage may occur if the following conditions are met:

• An adult consumes more than 4,000 mg of acetaminophen within a 24-hour period.

• A child takes more than 5 doses within a 24-hour period.

• The product is taken concurrently with other medications that contain acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, it is recommended that patients with compromised liver function adhere strictly to the dosing guidelines and avoid exceeding the recommended daily limits of acetaminophen. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

Taking more than the recommended dose may lead to serious health complications, including potential liver damage. It is essential for healthcare professionals to recognize the severity of an overdose and the importance of immediate intervention.

In the event of an accidental overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for guidance.

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly impact the outcome and mitigate the risk of severe health issues associated with overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

There have been reports of severe skin reactions associated with acetaminophen, including symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, 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. 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.

Patients should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use 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 also be directed to stop use and consult a healthcare professional. New symptoms or a cough that returns or occurs with a rash or persistent headache should 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 at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

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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