Cold and Flu Relief

Description

This product is a nighttime cold and flu relief formulation that contains three active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and doxylamine succinate, an antihistamine. The dosage form is liquid-filled softgels, which are alcohol-free. This product is not manufactured or distributed by the Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of the Procter & Gamble Company.

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

Patients should adhere strictly to the recommended dosage guidelines to avoid potential overdose. 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. It is imperative that the softgels are swallowed whole; they should not be crushed, chewed, or dissolved to ensure proper release and absorption of the active ingredients.

This product is not intended for use in children under 12 years of age. When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to confirm appropriate dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is contraindicated, and the consumption of alcoholic beverages should be avoided while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

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

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have a history of liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients taking blood thinners such as warfarin or those on sedatives or tranquilizers should consult a healthcare provider or pharmacist before use.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help, regardless of whether symptoms are present.

Patients should discontinue use and contact a healthcare professional if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires prompt evaluation.

Side Effects

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

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are initially present, as this can lead to significant liver damage.

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

In clinical observations, excitability has been noted, particularly in children, and marked drowsiness may occur in some patients. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and caution is advised when driving or operating machinery.

Patients should discontinue use and consult a healthcare provider if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms develop, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Overall, careful monitoring of symptoms and adherence to recommended dosages are essential to minimize the risk of adverse reactions associated with this product.

Drug Interactions

Concurrent use 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 conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Caution is advised for individuals using sedatives or tranquilizers, as the combination may enhance drowsiness. The consumption of alcohol alongside this medication, as well as with sedatives and tranquilizers, may further increase the risk of sedation and impairment. Monitoring for increased sedation and potential respiratory depression is recommended in these cases.

Packaging & NDC

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

Pediatric Use

Children under 12 years should not use this medication. For adults and children aged 12 years and over, the recommended dosage is 2 softgels taken with water every 6 hours, with a maximum of 4 doses in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, it is critical to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 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 the safety of both the mother and the developing fetus.

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 mothers.

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 be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of hepatotoxicity.

Patients should not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, they must avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage. Consumption of three or more alcoholic drinks per day while using this product is also contraindicated, as it may exacerbate liver injury.

Before using this product, patients with known liver disease should consult a healthcare professional. It is recommended that patients with compromised liver function avoid alcoholic beverages entirely while using this product to prevent potential adverse effects on liver health.

In the event of an overdose, which can lead to significant liver damage, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is critical for both adults and children.

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 advise patients and caregivers to seek immediate medical assistance or contact a Poison Control Center without delay if an overdose is suspected.

Recommended Actions

Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. The lack of immediate symptoms does not preclude the possibility of significant harm, and therefore, vigilance is necessary.

Potential Symptoms

While specific symptoms of overdose may vary, the risk of liver damage is a primary concern. Healthcare providers should monitor for any signs of hepatic impairment, which may include jaundice, abdominal pain, or changes in mental status.

Management Procedures

Upon identification of an overdose, healthcare professionals should initiate appropriate management protocols, which may include supportive care and monitoring of liver function. The involvement of a Poison Control Center can provide additional guidance on the necessary interventions based on the specific circumstances of the overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed that acetaminophen may cause severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Patients should be advised not to exceed the recommended dosage, as taking more than the prescribed amount can lead to liver damage. In the event of an overdose, it is crucial for patients to 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 apparent.

Healthcare providers should inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be cautioned against consuming alcoholic beverages, as alcohol, along with sedatives and tranquilizers, can enhance drowsiness.

Additionally, patients should be made aware of the importance of exercising caution when driving a motor vehicle or operating machinery due to the potential for drowsiness and impaired coordination.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 15º to 30ºC (59º to 86ºF). Care should be taken to avoid exposure to excessive heat to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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