Daytime Cold and Flu Relief

Description

No description information is available for the drug.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 30 mL every 4 hours as needed. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. It is important to consult a healthcare professional for children aged 4 to under 6 years, as specific dosing instructions should be obtained. The product is not recommended for use in children under 4 years of age.

Patients should not exceed 4 doses within a 24-hour period. It is essential to measure the dosage using only the dosing cup provided with the product; no other dosing devices should be utilized to ensure accurate measurement. The dosing cup should be kept with the product for convenience.

When using both Day Time and Night Time formulations, healthcare professionals should advise patients to carefully read each label to confirm the correct dosing instructions for each product.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to acetaminophen should not use this product due to the risk of severe allergic reactions.

The product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated to prevent the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, exceeding the recommended dosage is contraindicated, as it may lead to 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 adults must not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, and children must not exceed 4 doses (15 mL each) in the same timeframe. Caution is also warranted when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults who consume 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may induce severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must 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 fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions should be taken for individuals with specific health conditions. Patients should be directed to consult a healthcare provider prior to use if they have liver disease, respiratory issues such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough (e.g., associated with smoking, asthma, or emphysema), or a cough that produces excessive phlegm. Furthermore, it is essential to consult a doctor or pharmacist if the patient is concurrently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare provider if any of the following occur: worsening pain or cough lasting more than 5 days in children or 7 days in adults; worsening fever lasting more than 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the recommended dosage of acetaminophen. Adults should not take more than 4 doses (30 mL each) within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is heightened if acetaminophen is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, patients should be aware of the sore throat warning; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

This product is contraindicated in individuals with a known allergy to acetaminophen, those currently taking a prescription monoamine oxidase inhibitor (MAOI), or those who have taken an MAOI within the past 2 weeks. It should not be used in conjunction with any other drug containing acetaminophen. Patients uncertain about the presence of acetaminophen in their medications should consult a doctor or pharmacist.

Patients with liver disease, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, or persistent coughs should seek medical advice before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should also consult a healthcare provider prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if pain or cough worsens or persists beyond 5 days for children or 7 days for adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

In cases of overdose, which may lead to liver damage, immediate medical attention is necessary. Patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Cold and Flu Relief (acetaminophen dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours, with a maximum of 4 doses (15 mL each) in a 24-hour period. 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 monitor pediatric patients for the duration of pain or cough; if symptoms persist for more than 5 days, a consultation with a doctor is necessary. Additionally, if fever lasts more than 3 days, medical advice should be sought.

In cases of suspected overdose, immediate medical attention is critical, even if the child shows no signs or symptoms.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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, 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 breastfeeding.

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 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 should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure appropriate management and monitoring of potential complications associated with reduced kidney function.

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 imperative that patients do not exceed the maximum daily dosage of acetaminophen, which is 4 doses (30 mL each) for adults and 4 doses (15 mL each) for children within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this may increase the risk of liver injury.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, adults consuming three or more alcoholic drinks daily should refrain from using this product, as alcohol can exacerbate the risk of liver damage.

In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Overdosage

In the event of an overdose, it is crucial to recognize the potential for serious health consequences, particularly liver damage, which may occur when the recommended dosage is exceeded. Healthcare professionals should be vigilant in assessing patients who may have ingested an excessive amount of the medication.

Recommended Actions Immediate medical assistance is essential in cases of suspected overdose. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is critical, regardless of whether the individual exhibits any signs or symptoms of overdose. This is particularly important for both adults and children, as the absence of symptoms does not preclude the risk of significant harm.

Potential Symptoms While specific symptoms of overdose may vary, healthcare professionals should be aware that liver damage can occur even in the absence of immediate clinical manifestations. Continuous monitoring and evaluation of the patient’s condition are recommended to identify any delayed effects.

Management Procedures Upon confirmation of an overdose, appropriate management should be initiated based on the clinical presentation and the amount of the substance ingested. Supportive care and monitoring of liver function tests may be necessary, along with other interventions as deemed appropriate by the medical team.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical 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 about the importance of adhering to the recommended dosage, emphasizing that exceeding this dosage may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed to discontinue use and consult a doctor if their pain or cough worsens or persists beyond 5 days for children or 7 days for adults. Additionally, they should stop use and seek medical advice if fever intensifies or lasts more than 3 days, if there is any redness or swelling, or if new symptoms arise. Patients should also be cautioned to stop use and consult a healthcare professional if a cough recurs or occurs alongside a rash or persistent headache.

It is essential for patients to consult a doctor before using the medication if they have liver disease, breathing problems such as emphysema or chronic bronchitis, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, particularly those associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, patients experiencing a cough accompanied by excessive phlegm should consult a healthcare provider. Lastly, patients taking the blood-thinning medication warfarin should discuss their use of this product with a doctor or pharmacist before proceeding.

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 temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)