Nitetime Cold and Flu

Description

This product is a nighttime formulation designed for the relief of cold and flu symptoms. It contains 650 mg of acetaminophen, serving as a pain reliever and fever reducer, 30 mg of dextromethorphan HBr, which acts as a cough suppressant, and 12.5 mg of doxylamine succinate, an antihistamine. The combination of these active ingredients provides relief from headache, fever, sore throat, minor aches and pains, sneezing, runny nose, and cough.

The product is intended for use by individuals aged 12 years and older and contains 10% alcohol. It is packaged in fluid ounces (FL OZ) and milliliters (mL). The product is not manufactured or distributed by The Procter & Gamble Company, and Vicks® and NyQuil™ are registered trademarks of The Procter & Gamble Company.

The packaging includes a tamper-evident feature; do not use if the printed safety seal around the dosage cup or under the cap is broken or missing. This product is distributed by Walmart Inc., Bentonville, AR 72716.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, fever, sore throat, 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 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 to facilitate proper administration.

Children under 12 years of age should not use this product. When using other Day Time or Night Time formulations, it is essential to carefully read each label to confirm the correct dosing to prevent exceeding the recommended limits.

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.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated 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 significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems, chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients must be advised to stop taking the product and consult a doctor if any of the following occur: worsening pain or cough lasting more than seven days, the emergence of new symptoms, fever worsening or persisting beyond three days, presence of redness or swelling, or recurrence of cough accompanied by rash or headache lasting. 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 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms of overdose are apparent.

Patients may experience severe skin reactions associated with acetaminophen, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance promptly. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider.

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 or operating machinery.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than seven days, if new symptoms arise, if fever worsens or persists for more than three days, if redness or swelling is present, or if a cough recurs with a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

Drug Interactions

The concomitant use of monoamine oxidase inhibitors (MAOIs) with this medication is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within two weeks of discontinuing an MAOI.

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

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional before using this medication, as potential interactions may necessitate monitoring or dosage adjustments.

The use of alcohol, sedatives, and tranquilizers in combination with this medication may enhance drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Nitetime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, 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. When administered, excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect.

For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with a health professional before use.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, do not require specific dosage adjustments or face unique safety concerns based on the available prescribing information. The product is indicated for use in adults and children aged 12 years and older, suggesting that it may not be appropriate for younger populations, but it does not explicitly outline any precautions or recommendations tailored to geriatric patients.

The warnings section of the prescribing information does not identify any additional risks or considerations pertinent to elderly patients. However, it is recommended that individuals consult a healthcare provider prior to use if they have existing health conditions, although no specific geriatric considerations are mentioned in this context.

Healthcare providers should remain vigilant and monitor elderly patients for any potential adverse effects, given the general considerations surrounding this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 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 in 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 daily while using this product is also contraindicated, as it may exacerbate liver injury.

Before using this product, patients with a history of liver disease should 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 advised to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of prompt medical evaluation even in the absence of noticeable signs or symptoms of overdose.

Timely management can significantly influence outcomes, making awareness and readiness to act essential components of care in cases of suspected overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing 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. It is crucial to stress the importance of prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

When discussing the use of this product, healthcare providers should inform patients that excitability may occur, particularly in children. Patients should be made aware that marked drowsiness is a possible side effect and that they should avoid consuming alcoholic beverages while using this product. Additionally, caution should be advised when driving a motor vehicle or operating machinery, as the product may impair their ability to do so safely. It is also important to note that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients should be counseled accordingly.

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. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)