Multi-Symptom Nitetime

Description

VALUMEDS™ is a multi-symptom formulation designed for nighttime relief from cold and flu symptoms. It contains acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and doxylamine succinate, an antihistamine. This combination addresses various symptoms associated with cold and flu, providing comprehensive relief during the night. The product is comparable to the active ingredients found in VICKS® NyQUIL®.

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 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 dosage is to swallow two softgels with water every six hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing guidance.

The use of this product is not recommended for children under 4 years of age.

When utilizing both Nighttime and Daytime softgels, it is essential to carefully read each label to ensure accurate dosing and avoid exceeding the recommended limits.

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.

• The product should not be used to induce sleep in children.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to guidelines.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 4 doses within 24 hours is exceeded. Additionally, the risk increases when acetaminophen is taken concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Healthcare professionals should advise patients to seek medical attention if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Overdose Warning Taking more than the recommended dose can result in serious health complications. In the event of an overdose, immediate medical help should be sought, or a Poison Control Center should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

General Precautions Patients should consult a healthcare provider 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, it is advisable to consult a doctor or pharmacist before use if the patient is taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Emergency Medical Help In cases of overdose, immediate medical assistance or contact with a Poison Control Center is essential.

Discontinuation of Use Patients should stop taking this product and consult a healthcare professional 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 condition requiring further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, which can range from serious to common occurrences.

Severe liver damage is a significant concern associated with the use of this product, particularly in patients who exceed the maximum daily dosage of four doses within a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using the product.

Allergic reactions may manifest as severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

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 due to the potential for increased sedation.

Patients should discontinue use and consult a healthcare professional if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or a headache that lasts. These symptoms may indicate a serious underlying condition.

An overdose of this product can lead to serious health complications. Patients are urged to seek immediate medical attention or contact a Poison Control Center if they suspect an overdose, even in the absence of noticeable signs or symptoms. Prompt medical intervention is crucial for both adults and children in such cases.

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.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease should not use this medication. This contraindication extends for a period of two weeks following the discontinuation of the MAOI.

Caution is advised when using this medication in conjunction with sedatives or tranquilizers. Patients should consult a healthcare professional prior to use to assess potential interactions and the need for dosage adjustments.

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

It is important to note that the concurrent use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating careful monitoring of patients for increased sedation and impairment.

Packaging & NDC

Below are the non-prescription pack sizes of Multi-Symptom Nitetime (acetaminophen, dextromethorphan hydrobromide, and 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 contraindicated in children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is to swallow 2 softgels with water every 6 hours.

It is important to note that excitability may occur, particularly in children.

Geriatric Use

There is no specific information 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.

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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 patients to adhere to the following guidelines to minimize this risk:

• The maximum daily amount of this product is limited to 4 doses within a 24-hour period. Exceeding this limit may lead to severe liver damage.

• Patients should avoid concurrent use with other medications that contain acetaminophen, as this can further increase the risk of liver injury.

• Consumption of 3 or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the potential for liver damage.

Before using this product, patients with liver disease should consult a healthcare professional to assess the appropriateness of use and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

Taking more than the recommended dose of this medication can lead to serious health complications. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay.

Recommended Actions

Prompt medical attention is crucial for both adults and children, regardless of whether any signs or symptoms are immediately apparent. Healthcare professionals should be prepared to provide supportive care and monitor the patient closely for any potential adverse effects that may arise from the overdose.

Potential Symptoms

While specific symptoms of overdose may vary depending on the substance involved, it is essential to remain vigilant for any unusual or severe reactions. Early recognition and intervention can significantly improve outcomes in cases of overdose.

In summary, the importance of swift action in response to an overdose cannot be overstated, as timely medical intervention is vital for ensuring patient safety and mitigating health risks.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, it is recommended to stop use and consult a healthcare professional if any of the following occur: worsening pain or cough lasting more than 7 days; fever that worsens or persists for more than 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or a headache that persists. These symptoms may indicate a serious underlying condition.

Furthermore, there is a warning regarding overdose, as exceeding the recommended dosage can lead to serious health complications. In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center promptly, as timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed 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.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product to induce sleep in children. They should be instructed to discontinue use and seek medical advice if pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Additionally, patients should be informed that a returning cough, especially if accompanied by a rash or a persistent headache, may indicate a serious condition requiring medical attention.

When using this product, patients should be advised to adhere strictly to the recommended dosage and to be aware that excitability may occur, particularly in children. Marked drowsiness is a potential side effect, and patients should be cautioned to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, 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 taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist 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, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat to ensure the integrity of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are instructed to swallow 2 softgels with water every 6 hours. For children aged 4 to under 12 years, it is recommended to consult a doctor before use, while the medication is not advised for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. 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 Multi-Symptom Nitetime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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