Nighttime Cold and Flu

Description

This product is a nighttime cold and flu remedy formulated for individuals aged 12 and over. It contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and doxylamine succinate, an antihistamine. The formulation provides multi-symptom relief for headache, fever, sore throat, minor aches and pains, sneezing, runny nose, and cough. The product is presented in a cherry flavor and contains 10% alcohol. It is packaged in fluid ounces (FL OZ) and is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895. The product is tamper evident; do not use if the printed safety seal around the dosage cup or under the cap is broken or missing. This product is not manufactured or distributed by The Procter & Gamble Company, and Vicks® and NyQuil™ are registered trademarks of The Procter & Gamble Company.

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, 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 to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL administered every 6 hours as needed. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times.

For children under 12 years of age, the use of this product is not recommended.

When utilizing other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to confirm appropriate dosing and avoid potential interactions.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or within 2 weeks of discontinuing an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals should be aware of to ensure safe use.

Liver Warning Severe liver damage may occur if the patient exceeds 4000 mg of acetaminophen in a 24-hour period, uses this product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms can include skin reddening, blisters, and rash. If any skin reaction occurs, the patient should discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, the patient should consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions:

• Liver disease

• Glaucoma

• A cough that produces excessive phlegm (mucus)

• Breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema

• Difficulty urinating due to an enlarged prostate gland

Additionally, patients should be instructed to seek guidance from a doctor or pharmacist before use if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation of Use Patients should stop taking this product and consult a doctor if:

• Pain or cough worsens or persists for more than seven days

• Fever worsens or lasts more than three days

• Redness or swelling is observed

• New symptoms develop

• Cough recurs or occurs alongside a rash or headache that lasts.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4000 mg in 24 hours, 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.

Participants using this product may experience excitability, particularly in children, as well as marked drowsiness. Caution is advised when driving or operating machinery, and the consumption of alcoholic drinks, sedatives, and tranquilizers should be avoided, as these may exacerbate drowsiness.

Patients are advised to stop use and consult a doctor 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, or if new symptoms arise. A return of cough accompanied by a rash or headache that lasts may indicate serious conditions requiring medical evaluation.

In cases of overdose, which may result from taking more than the recommended dose, patients may experience liver damage. Immediate medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. In such instances, contacting a Poison Control Center (1-800-222-1222) is strongly recommended.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within two weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Caution is advised when this medication is used in conjunction with sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking these types of medications.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional before using this medication, as potential interactions may affect anticoagulation control.

The use of alcohol, sedatives, and tranquilizers in combination with this medication may enhance drowsiness. Monitoring for increased sedation is recommended in patients who are concurrently using these substances.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur with use, particularly in children. Additionally, marked drowsiness is a potential side effect that may affect pediatric patients.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 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 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 lack of data 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 closely monitored due to the potential for severe liver damage associated with this product, which contains acetaminophen. It is critical that patients do not exceed 4000 mg of acetaminophen in a 24-hour period, as exceeding this limit may lead to significant liver injury. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Overdosage

Taking more than the recommended dose of the medication may lead to significant liver damage. 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.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Healthcare professionals should be vigilant in assessing the situation and initiating appropriate interventions as necessary.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of monitoring for any signs of hepatic impairment.

In summary, due to the potential severity of an overdose, immediate action and professional medical evaluation are essential to mitigate risks and ensure patient safety.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the risks associated with overdose. It is important to communicate that taking more than the recommended dose 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. Emphasize that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent. This information is vital for ensuring patient safety and preventing serious health complications.

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 handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

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. It is contraindicated for use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. An overdose warning is in place, as exceeding the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)