Xl-3 Night Time

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates sore throat, headache, minor aches and pains, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

The product should be taken only as recommended, and healthcare professionals are advised to refer to the Overdose warning for further guidance. It is essential to utilize the dosing cup provided with the product for accurate measurement and administration.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (equivalent to 2 tablespoons) every 6 hours. It is important 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 must still not exceed 4 doses in a 24-hour period.

For children aged 4 to under 12 years, it is recommended to consult a physician for appropriate dosing. The product is contraindicated for use in children under 4 years of age.

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.

• Duration of use exceeding 10 days for pain, unless directed by a healthcare professional.

• Duration of use exceeding 3 days for fever, unless directed by a healthcare professional.

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

• Use in children for the purpose of inducing sleep, as this is not an approved indication.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has the potential to cause severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a 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 two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

Patients should be instructed to stop use and seek medical advice if any of the following occur: redness or swelling, symptoms that do not improve within seven days or are accompanied by fever, worsening fever lasting more than three days, the emergence of new symptoms, or a cough that lasts more than seven days, recurs, or occurs with fever, rash, or headache. These symptoms may indicate a serious underlying condition.

Healthcare professionals should remain vigilant for these warnings and ensure appropriate monitoring and intervention as necessary.

Side Effects

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

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may lead to serious health problems including liver damage, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222), even if no symptoms are initially apparent.

Patients should also be alert to the possibility of severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical help immediately.

In addition, patients should 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.

Patients are encouraged to stop using the product and seek medical advice if they notice redness or swelling, if symptoms do not improve within seven days or are accompanied by fever, if fever worsens or lasts more than three days, if new symptoms arise, or if a cough persists for more than seven days, recurs, or occurs with fever, rash, or headache. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other products containing acetaminophen or when consumed with three or more alcoholic beverages daily. It is advisable to monitor liver function and limit the intake of acetaminophen in such scenarios.

Doxylamine may enhance drowsiness when administered alongside sedatives or tranquilizers, which can lead to an increased risk of sedation. Caution is recommended when combining these agents, and patients should be monitored for excessive sedation.

Warfarin, an anticoagulant, may experience altered effects when taken with acetaminophen. It is essential to monitor International Normalized Ratio (INR) levels closely in patients receiving this combination to ensure therapeutic efficacy and safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 30 mL (2 tablespoons) every 6 hours.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

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 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 available data 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 lack of information 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. It is critical to note that severe liver damage may occur if the total daily dosage of acetaminophen exceeds 4,000 mg. Therefore, patients with compromised liver function should be closely monitored for their total acetaminophen intake from all sources, including other medications that may also contain acetaminophen.

Additionally, patients should be advised against the concurrent use of this product with other drugs containing acetaminophen, as this may further increase the risk of severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily are at an elevated risk for liver damage when using this product. It is recommended that these patients either avoid alcohol consumption or consult with a healthcare professional for guidance on the safe use of this product in the context of their liver function. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose of acetaminophen can lead to serious health complications, particularly liver damage. It is crucial for healthcare professionals to be aware of the potential risks associated with overdose and the necessary actions to take in such situations.

In the event 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. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are initially apparent.

It is important to note that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. This threshold underscores the necessity for vigilance in monitoring dosages and recognizing the signs of overdose. Early intervention can significantly impact patient outcomes and mitigate the risk of long-term health issues.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use of the product 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 informed 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 cautioned against using this product for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be instructed not to use this product to induce sleep in children. They should be advised to stop using the product and consult a doctor if they experience redness or swelling, if symptoms do not improve within 7 days, or if symptoms are accompanied by a fever. Additionally, patients should be informed to seek medical advice if a fever worsens or persists beyond 3 days, or if new symptoms arise.

Healthcare providers should inform patients that if a cough lasts more than 7 days, returns, or occurs with fever, rash, or a persistent headache, they should seek medical attention, as these may indicate a serious condition. Patients should be reminded to adhere strictly to the recommended dosage and to avoid alcoholic beverages while using this product.

Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness may also be a side effect. Caution should be advised when driving or operating machinery while using this product. Patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Before using this product, patients should be encouraged to consult a healthcare provider if they have a sodium-restricted diet, liver disease, glaucoma, a cough with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Patients with difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should 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 the temperature range of 58° to 86°F (15° to 30°C) to maintain its efficacy and integrity. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable environment to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)