Nighttime Cold and Flu Relief

Description

CVS Health® Multi-Symptom Nighttime Cold & Flu is formulated to provide relief from various symptoms associated with colds and flu. The active ingredients include acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and doxylamine succinate, an antihistamine. This product is designed to alleviate aches, fever, sore throat, cough, sneezing, and runny nose. It is presented in an original flavor and contains 10% alcohol. The dosage form is a liquid, with a total volume of 12 fluid ounces (355 mL).

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. It is essential to utilize only the dose cup provided with the medication to ensure accurate dosing. 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 30 mL every 6 hours as needed.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional 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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

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, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate an allergic reaction. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant in assessing patients for severe sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

General precautions should be taken when considering the use of this product. Patients should be advised to consult a healthcare professional prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than seven days, fever worsens or persists beyond three days, redness or swelling is observed, new symptoms develop, or if a cough recurs alongside a rash or headache that lasts. 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, 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.

Participants should be cautious of marked drowsiness, which may occur, particularly when combined with alcohol, sedatives, or tranquilizers, as these substances can exacerbate drowsiness. Excitability has also been reported, especially in children. Patients are advised to avoid alcoholic beverages and to exercise caution 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 arise, or if a cough recurs with a rash or headache lasting longer than expected, as these may indicate a serious condition.

It is recommended that patients consult a healthcare professional prior to use if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate, a persistent cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Additionally, patients should seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are present, as prompt intervention is critical for both adults and children.

Drug Interactions

Concurrent use of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

Caution is advised when this medication is used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric disorders, or Parkinson’s disease. Patients should seek guidance from a healthcare provider before initiating this medication if they are currently taking an MAOI or have discontinued an MAOI within the past two weeks.

The concomitant administration of this medication with warfarin, an anticoagulant, may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety and to adjust warfarin dosage as necessary.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu Relief (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. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics 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 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 on the excretion of this drug 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 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 and monitoring.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs.

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been associated with acetaminophen use. Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Patients experiencing pain or cough that worsens or persists beyond 7 days, or fever that intensifies or lasts more than 3 days, should seek medical attention. The presence of redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that persists may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use.

Healthcare providers should counsel patients to discontinue use and consult a doctor if pain or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Additionally, patients should be instructed to seek medical advice if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When 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. Patients should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be advised to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough related to smoking, asthma, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients should be encouraged to speak with their healthcare provider or pharmacist 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 20-25°C (68-77°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 to prevent degradation.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. For children aged 4 to under 12 years, it is advised to consult a doctor regarding appropriate dosing, while the use of this medication is not recommended for children under 4 years of age.

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 Nighttime Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)