Night Time

Description

NDC 68016-135-00. Premier Value® Night Time Multi-Symptom Cold/Flu Relief is a cherry-flavored liquid formulation designed for individuals aged 12 and older. Each 4 FL OZ (120 mL) dose contains the following active ingredients: Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; and Doxylamine Succinate, an antihistamine. This product addresses symptoms including cough, fever and body aches, sore throat, sneezing, and runny nose. The product is independently tested for satisfaction and is guaranteed. It is important to note that the product is not manufactured or distributed by Reckitt Benckiser Inc., the distributor of Delsym® Night Time Multi-Symptom. Users should not use the product if the printed seal under the cap is torn or missing. Distributed by Chan Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431. BX-007.

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 sore throat and bronchial irritation, runny nose, sneezing, minor aches and pains, sore throat, headache, and fever.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage to avoid the risk of overdose. The medication should be measured using a dose cup or a tablespoon (TBSP) for accuracy.

The maximum allowable dosage is four doses within a 24-hour period. It is essential to ensure that patients do not exceed this limit to maintain safety and efficacy.

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, as this may lead to serious drug interactions. Healthcare professionals should be consulted to verify the presence of MAOIs in prescribed medications.

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

Additionally, while using this product, it is essential to adhere to the recommended dosage and to avoid the consumption of alcoholic beverages, as this may exacerbate potential side effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to mitigate the risk of liver injury:

• Do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount.

• Avoid concurrent use with other medications that contain acetaminophen.

• Limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product.

In addition, healthcare providers should be vigilant regarding the management of sore throat symptoms. If a patient presents with a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur:

• Redness or swelling at the site of symptoms.

• Symptoms do not improve within 7 days or are accompanied by fever.

• Fever worsens or persists for more than 3 days.

• New symptoms develop.

• A cough lasts more than 7 days, recurs, or occurs with fever, rash, or a persistent headache.

These signs may indicate a serious underlying condition that requires further evaluation and intervention.

Emergency medical assistance should be sought if any severe adverse reactions occur, although specific instructions for such situations are not provided in the current guidelines.

Regular monitoring and appropriate laboratory tests are not specified; however, healthcare professionals should remain alert to the potential need for further assessment based on the clinical presentation of the patient.

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 the event of an overdose, which may occur if the recommended dose is exceeded, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to stop using the product and consult a doctor if they experience redness or swelling, if symptoms do not improve within seven days, or if they are accompanied by fever. Furthermore, if fever worsens or persists for more than three days, or if new symptoms arise, medical advice should be sought. A cough lasting more than seven days, recurring cough, or cough associated with fever, rash, or persistent headache may indicate a serious condition and warrants immediate medical consultation.

Before using this product, patients should consult a doctor if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Patients with a cough that produces excessive phlegm (mucus) or those on a sodium-restricted diet should also seek medical advice prior to use.

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

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment in activities requiring alertness.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may experience excitability, particularly in children. Additionally, marked drowsiness has been observed in this population. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments when receiving this medication, as there are no noted safety concerns associated with its use in this population. However, healthcare providers should remain vigilant and monitor for any potential adverse effects, as individual responses may vary. It is advisable to consider the overall health status and comorbidities of geriatric patients when prescribing this medication to ensure optimal therapeutic outcomes.

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 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 the available data regarding 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 lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than 3 alcoholic drinks per day while using this product. Given the potential for significant hepatic toxicity, healthcare providers should assess liver function and consider alternative therapies for patients with moderate to severe hepatic impairment. Regular monitoring of liver enzymes may be warranted to ensure patient safety.

Overdosage

In cases of overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In the event of an overdose, individuals should seek medical help or contact a Poison Control Center without delay. This action is essential for both adults and children, as quick intervention can mitigate the risk of severe complications, even in the absence of noticeable signs or symptoms.

Healthcare providers are advised to monitor patients closely and initiate appropriate management procedures as soon as an overdose is suspected. Early recognition and treatment are vital to prevent adverse outcomes associated with liver damage.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: excitability, particularly in children, and marked drowsiness. Additionally, it has been noted that the concomitant use of alcohol, sedatives, and tranquilizers may enhance the sedative effects, leading to increased drowsiness.

Patient Counseling

Patients should be advised to keep this medication 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 drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

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 professional.

Patients should not use this medication to induce sleepiness in children. They should be instructed to stop using the product 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 seek medical advice if a fever worsens or persists for more than three days, or if new symptoms arise. If a cough lasts longer than seven days, recurs, or occurs with fever, rash, or a persistent headache, patients should also be advised to contact a healthcare provider, as these may indicate a serious condition.

While using this product, patients should adhere strictly to the recommended dosage and avoid exceeding the directed amount. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be cautioned that the consumption of alcohol, sedatives, and tranquilizers may enhance drowsiness, and they should avoid alcoholic beverages while using this medication.

Patients should exercise caution when driving or operating machinery due to the potential for drowsiness. It is essential to advise patients to consult a doctor before using this product if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, or any breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with a cough that produces excessive phlegm (mucus) should also seek medical advice prior to use.

Furthermore, patients on a sodium-restricted diet or those taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product. Lastly, patients taking sedatives or tranquilizers should also seek professional advice before use.

Storage and Handling

The product is supplied in a carton that contains essential information for use. It is important to store the product at a temperature range of 20-25° C (68-77° F). Refrigeration is not recommended, as the product should not be stored in cold conditions. To ensure proper usage, the carton should be retained for full directions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)