Night-Time Cherry

Description

NDC 68016-146-01. This product, Premier Value® Night-Time Multi-Symptom Cold/Flu Relief, is formulated with active ingredients comparable to those found in Vicks® NyQuil®. It contains Acetaminophen as a pain reliever and fever reducer, Dextromethorphan HBr as a cough suppressant, and Doxylamine Succinate as an antihistamine. The product is presented in a liquid dosage form with a cherry flavor, packaged in a 12 FL OZ (354 mL) container. It is independently tested for satisfaction and is guaranteed by the distributor, Chan Drug Consortium, located at 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431. The product should not be used if the printed seal under the cap is torn or missing. This product is not manufactured or distributed by Procter and Gamble, the owner of the registered trademark Vicks® NyQuil®. For any dissatisfaction, customers are advised to return the product to the store of purchase for a full refund.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. These symptoms include sore throat, headache, minor aches and pains, fever, runny nose, sneezing, and cough due to minor sore throat and bronchial irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to administer the medication strictly as recommended, adhering to the guidelines outlined in the Overdose warnings. The medication should be measured using a dose cup or a tablespoon (TBSP) to ensure accurate dosing.

The maximum allowable dosage is four doses within a 24-hour period. When administering both Night Time and Day Time formulations, it is imperative to limit the total combined doses to no more than four within the same 24-hour timeframe. This precaution is essential to prevent potential overdose and ensure patient safety.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek guidance from a healthcare professional.

• For the purpose of inducing sleepiness in children, as this use is not recommended.

Additionally, while using this product, it is important to adhere to the following precautions:

• Do not exceed the recommended dosage.

• Avoid consumption of alcoholic beverages, as alcohol may enhance drowsiness when combined with this product.

Warnings and Precautions

Failure to adhere to the following warnings may result in serious health consequences.

Liver Warning This product contains acetaminophen, which can lead to severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

General Precautions Healthcare professionals should advise patients to use this product strictly as directed. Alcoholic beverages should be avoided during use, as they may exacerbate drowsiness. Patients, particularly children, may experience excitability. Marked drowsiness is a potential side effect; therefore, caution is advised when driving or operating machinery. The concomitant use of alcohol, sedatives, and tranquilizers may further increase drowsiness.

When to Seek Medical Attention Patients should discontinue use and contact their healthcare provider if any of the following occur: redness or swelling at the site of use, symptoms that do not improve within 7 days or are accompanied by fever, worsening fever lasting more than 3 days, the emergence of new symptoms, or a cough that persists beyond 7 days, recurs, or occurs with fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition requiring medical 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 four doses in a 24-hour period, which is the maximum daily amount, or if they take this product in conjunction with other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may increase the risk of liver damage.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

An overdose of this product can lead to serious health problems. Patients should seek immediate medical assistance or contact a Poison Control Center if they suspect an overdose, as quick medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are also advised to discontinue use and consult a doctor if they experience redness or swelling, if symptoms do not improve within seven days or are accompanied by fever, if fever worsens or lasts more than three days, or if new symptoms arise. A cough that lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache may indicate a serious condition and warrants medical evaluation.

Before using this product, patients should consult a doctor if they have a sodium-restricted diet, liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Those experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

Furthermore, patients should inform their doctor or pharmacist if they are taking sedatives or tranquilizers, or if they are using the blood-thinning medication warfarin, as these may interact with the product.

Drug Interactions

Co-administration 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 depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI. This interaction may lead to serious and potentially life-threatening side effects.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding due to potential interactions.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Night-Time Cherry (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely due to the potential for excitability, which may be more pronounced in children. Additionally, marked drowsiness has been reported, necessitating caution when administering this medication to pediatric populations. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 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 not been specifically addressed in terms of dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in this population to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed 4 doses in a 24-hour period, which is the maximum daily amount when considering other medications that also contain acetaminophen. Additionally, patients consuming 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage. Therefore, it is recommended that patients with compromised liver function adhere strictly to the dosing guidelines and consult with a healthcare professional regarding their alcohol consumption while using this product. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent potential adverse effects.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the onset of symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of proactive management even in the absence of observable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of these critical steps to take in the case of an overdose, emphasizing the necessity of quick medical attention to mitigate potential health risks.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include allergic reactions, such as anaphylaxis; liver injury, with instances of acute liver failure; and serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Additional reported events encompass gastrointestinal bleeding, renal impairment, and respiratory depression.

Neurological effects have also been noted, including drowsiness, sedation, excitability—particularly in children—hallucinations, confusion, and agitation. Paradoxical reactions, such as increased cough, have been observed as well. Other adverse reactions reported include nausea, vomiting, and dizziness.

These reactions were documented during postmarketing surveillance and may not be directly related to the use of the product. The frequency of these adverse reactions is not known. Healthcare professionals are encouraged to report any adverse events or side effects to the FDA.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should consult a healthcare professional.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare provider.

This product should not be used to induce sleepiness in children. Patients must be instructed to discontinue use and consult a doctor if they experience redness or swelling, if symptoms do not improve within seven days, or if symptoms are accompanied by a fever. Additionally, patients should stop use and seek medical advice if a fever worsens or persists for more than three days, or if new symptoms arise. They should also be advised to stop use and consult a doctor if a cough lasts more than seven days, recurs, or occurs with fever, rash, or a persistent headache, as these may indicate a serious condition.

While using this product, patients should adhere strictly to the recommended dosage and avoid consuming alcoholic beverages, as this may exacerbate drowsiness. Patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a potential side effect. Caution should be exercised when driving or operating machinery.

Patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness when using this product. It is advisable for patients to consult a doctor before use if they are on a sodium-restricted diet, have liver disease, glaucoma, or a cough associated with excessive phlegm. Patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland, or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should consult a healthcare professional before using this product.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)