Xl-3 Xtreme

Description

XL-3* Xtreme is a liquid formulation indicated for night time multi-symptom relief of cold and flu. The product contains the following active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and doxylamine succinate, an antihistamine.

The formulation is presented in a 12 FL OZ (354 mL) volume and features a cherry flavor. Inactive ingredients include citric acid, FD & C Blue No. 1, FD & C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose.

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 known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be taken only as recommended, and healthcare professionals should refer to the Overdose warning for further guidance.

For administration, a dose cup or tablespoon (TBSP) should be utilized. The maximum allowable dosage is four doses within a 24-hour period. When administering Night Time doses at night and Day Time doses during the day, the total combined doses must not exceed four within the same 24-hour timeframe.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (equivalent to 2 TBSP) every 6 hours. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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 avoid masking underlying conditions.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have stopped MAOI therapy within the last 2 weeks should not use this product, as it may lead to serious drug interactions.

• Use in children to induce sleep is contraindicated, as it may pose safety risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, ensuring that no more than 4,000 mg of acetaminophen is taken within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this may increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product can further elevate the risk of severe liver damage.

Acetaminophen has been 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 should be instructed to discontinue use immediately and seek medical assistance without delay.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, it is imperative that patients consult a healthcare provider promptly.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: redness or swelling at the site of use, lack of improvement in symptoms within seven days, fever that worsens or persists beyond three days, the emergence of new symptoms, or a cough that lasts more than seven days, recurs, or is accompanied by fever, rash, or a headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, 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.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Overdose of acetaminophen can lead to serious health complications, including liver damage. In the event of an accidental overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, even if no symptoms are immediately apparent.

Patients should discontinue use and consult a doctor if they experience 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, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have a sodium-restricted diet, liver disease, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if they have difficulty urinating due to an enlarged prostate gland.

Additionally, patients are advised to consult a doctor or pharmacist before use if they are taking sedatives or tranquilizers, or if they are using the blood-thinning medication warfarin.

Drug Interactions

Co-administration of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of MAOI therapy. This interaction may lead to serious and potentially life-threatening side effects.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding due to potential interactions.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating caution in activities requiring alertness, such as driving or operating machinery.

Packaging & NDC

Below are the non-prescription pack sizes of Xl-3 Xtreme (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.

Caution is advised as excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness has been reported, necessitating careful monitoring.

It is essential to keep the product out of reach of children. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as no particular safety concerns have been identified in the provided information. However, it is advisable for geriatric patients to consult a healthcare provider prior to use, especially if they have a history of liver disease, as this condition may pose additional risks.

Marked drowsiness is a potential side effect of this medication, and elderly patients may experience this effect more intensely due to their increased sensitivity to side effects. Caution is warranted, particularly in those who may be concurrently using alcohol, sedatives, or tranquilizers, as these substances can further enhance drowsiness. Given that elderly patients often take multiple medications, careful monitoring for additive effects is recommended to ensure their safety and well-being.

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 no specific data available regarding the excretion of this medication in 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 a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage increases if patients take other medications containing acetaminophen or consume three or more alcoholic drinks daily while using this product.

Due to these risks, patients with compromised liver function are advised to adhere strictly to the recommended dosage and to consult healthcare professionals for personalized guidance regarding the safe use of this product. Regular assessment of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

In the event of an overdose, defined as the ingestion of a quantity exceeding the recommended dose, serious health complications may arise, including potential liver damage.

It is imperative that individuals who suspect an accidental overdose seek immediate medical assistance. Healthcare professionals should advise contacting a Poison Control Center at 1-800-222-1222 without delay.

Prompt medical evaluation is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can significantly mitigate the risks associated with overdose and improve patient outcomes.

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

Severe skin reactions have been reported in association with acetaminophen use, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek immediate medical assistance.

Additionally, cases of overdose have been documented, which may lead to serious health complications, including liver damage. In instances of accidental overdose, it is crucial to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients 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 instructed not to use this product for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare provider. Additionally, patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking MAOI drugs within the last two weeks. If patients are unsure whether their prescription medication contains an MAOI, they should seek guidance from a doctor or pharmacist.

It is essential to inform patients that this product should not be used to induce sleep in children. Patients should be advised to discontinue use 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. They should also be instructed to stop use and seek medical advice if fever worsens or persists beyond 3 days, if new symptoms arise, or if a cough lasts more than 7 days, recurs, or occurs with fever, rash, or headache, as these may indicate a serious condition.

While using this product, patients should be reminded to adhere strictly to the recommended dosage and to avoid consuming alcoholic beverages. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness may also result. Patients should exercise caution when driving or operating machinery while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be encouraged to consult a doctor before using this product if they are on a sodium-restricted diet, have liver disease, glaucoma, a cough with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek medical advice if they have difficulty urinating due to an enlarged prostate gland or if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)