Tylo Cold and Flu

Description

TYLO COLD & FLU (Night) is a combination medication formulated to alleviate symptoms associated with cold and flu. Each dosage unit contains 325 mg of acetaminophen, an analgesic and antipyretic agent; 15 mg of dextromethorphan HBr, a cough suppressant; and 6.25 mg of doxylamine succinate, an antihistamine that provides relief from allergy symptoms and aids in sleep. The product is designed for nighttime use to help manage discomfort and promote rest during illness.

Uses and Indications

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

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two Softgels taken with water every six hours as needed.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not indicated 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 drug 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of MAOIs in current medications, seek advice from a healthcare professional.

Additionally, this product should be kept out of reach of children, and it is advised not to exceed the recommended dosage. Alcoholic beverages should be avoided, as they may enhance drowsiness, particularly when combined with sedatives or tranquilizers. Caution is advised when driving or operating machinery due to potential drowsiness.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: exceeding 4 doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Healthcare professionals should advise patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult a doctor or pharmacist for clarification.

This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, which is commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should seek guidance from a healthcare provider if they are unsure whether their prescription includes an MAOI.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact their healthcare provider if any of the following occur: pain or cough worsens or persists beyond 7 days; fever worsens or lasts more than 3 days, especially if accompanied by redness or swelling; new symptoms develop; or if a cough recurs or is associated with a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

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 the maximum daily dosage of four doses within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving a motor vehicle or operating machinery due to the potential for increased sedation.

Patients should discontinue use and seek medical advice if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for more than three days, or if redness or swelling is present. The emergence of new symptoms or a recurrence of cough accompanied by a rash or headache that lasts should also prompt immediate consultation, as these may indicate a serious condition.

It is critical to adhere to the recommended dosage, as taking more than directed can lead to serious health complications. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this medication with any other drug 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 an MAOI. 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 or other adverse effects.

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.

Packaging & NDC

Below are the non-prescription pack sizes of Tylo Cold and Flu (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 not recommended for children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or modifications indicated for this population in the provided information. However, healthcare providers should remain vigilant in monitoring for any potential age-related changes that could affect drug metabolism and response. It is advisable to assess the overall health status and comorbidities of geriatric 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 considered in these populations to ensure the safety of both the mother and the fetus or 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than 3 drinks per day while using this product to mitigate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to recognize that taking more than the recommended dosage can lead to serious health complications. Immediate medical assistance should be sought, and healthcare professionals are advised to contact a Poison Control Center without delay.

Recommended Actions Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. The potential for severe health issues necessitates a proactive approach to management in cases of suspected overdose.

Potential Symptoms While specific symptoms of overdose may vary depending on the substance involved, the absence of symptoms does not preclude the possibility of serious effects. Therefore, vigilance and timely intervention are essential in all overdose scenarios.

Healthcare professionals should ensure that patients and caregivers are aware of these critical steps to mitigate risks associated with overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis, and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Instances of liver injury and renal injury have also been documented.

Gastrointestinal bleeding, along with hematologic reactions such as thrombocytopenia and leukopenia, were reported. Cardiovascular events, including arrhythmias and hypotension, have been noted, as well as central nervous system effects, which encompass seizures and confusion. Additionally, respiratory depression, drowsiness, and sedation were observed, alongside excitability, particularly in children.

These adverse reactions were reported during the postmarketing experience and may not have been observed in clinical trials.

Patient Counseling

Healthcare providers should advise patients to keep this medication 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.

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 stopped taking an MAOI within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their pain or cough worsens or persists for more than 7 days. Additionally, they should stop using the product and consult a doctor if their fever worsens or lasts more than 3 days, or if they experience redness or swelling. Patients should also be advised to seek medical attention if new symptoms arise or if a cough returns, particularly if accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be cautioned not to exceed the recommended dosage. They should be made aware that excitability may occur, especially in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be warned to exercise caution when driving or operating machinery while using this product. It is also essential to recommend that patients consult a doctor before use if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients with difficulty urinating due to an enlarged prostate gland should seek medical advice before using this product.

Lastly, patients should be encouraged to consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels taken with water every 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor, while the use in children under 4 years is not recommended.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Patients are also advised to avoid alcoholic beverages and to exercise caution when driving or operating machinery.

Drug Information (PDF)

This file contains official product information for Tylo Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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