Nighttime

Description

Kroger® NightTime Cold & Flu is a liquid formulation designed for powerful nighttime relief from multiple cold and flu symptoms. The product contains active ingredients including acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and doxylamine succinate, an antihistamine. The formulation includes 10% alcohol and is available in an original flavor. Each bottle contains 12 fluid ounces (354 mL). This product is comparable to the active ingredients found in VICKS® NYQUIL® COLD & FLU, as noted on the back panel.

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. The provided dose cup must be used for accurate measurement. It is imperative not to exceed 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, refrain from using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than three drinks per day while using this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

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 should be taken when considering the use of this product. Patients should be advised to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, glaucoma, a cough that produces excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough associated with 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 the event of an overdose, immediate medical attention is crucial. 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 must be advised to discontinue use and contact a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists for more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with the use of this product include the potential for severe liver damage, particularly if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, combines it with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using the product.

Patients should be aware of the risk of severe skin reactions, which may 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, 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 promptly.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers can exacerbate drowsiness.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients with liver disease, glaucoma, excessive phlegm, breathing problems such as emphysema or chronic bronchitis, urinary difficulties due to an enlarged prostate, persistent cough associated with smoking, asthma, or emphysema, or those on a sodium-restricted diet should seek medical advice. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a healthcare professional prior to use.

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 drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the potential for acetaminophen overdose and associated hepatotoxicity.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease should consult a healthcare professional before using this medication. This consultation is also advised for patients who have discontinued MAOI therapy within the past two weeks, as interactions may still pose a risk.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. The combination may elevate the risk of bleeding; therefore, monitoring of coagulation parameters is recommended to ensure patient safety. Adjustments to warfarin dosage may be necessary based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime (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 not recommended for children under 4 years of age.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, 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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Individualized assessment and clinical judgment are essential when determining the appropriateness of treatment in elderly patients.

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may necessitate careful consideration of the risks associated with acetaminophen, which is a component of this formulation.

It is important to note that severe liver damage can occur if the total daily dosage of acetaminophen exceeds 4,000 mg within a 24-hour period. Additionally, the risk of liver injury increases when acetaminophen is taken in conjunction with other medications containing acetaminophen or when the patient consumes three or more alcoholic beverages daily while using this product.

Due to these potential risks, patients with compromised liver function should be closely monitored for any signs of liver toxicity and may require dosage adjustments or alternative therapeutic options based on their individual health status.

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 adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability has been observed, particularly in pediatric populations. Additionally, marked drowsiness may occur, which can be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 for clarification.

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 one within the last 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. Additionally, they should be instructed to discontinue use and consult a doctor if their 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. Patients should also be informed to seek medical advice if their cough returns 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 is a possible side effect. They should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. Patients should also be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should recommend that patients 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 advised to speak with a doctor or pharmacist before use 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 should be ensured to prevent exposure to extreme temperatures.

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. Patients are also cautioned to exercise care when driving or operating machinery, as the medication may impair their ability to do so. Additionally, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Drug Information (PDF)

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

View product document (PDF)