Multi-Symptom Nitetime

Description

Nighttime Multi-symptom Cold & Flu is a combination medication formulated to provide relief from various cold and flu symptoms. Each softgel contains acetaminophen, a pain reliever and fever reducer, dextromethorphan HBr, a cough suppressant, and doxylamine succinate, an antihistamine. This formulation is designed to alleviate headache and fever, sore throat, minor aches and pains, cough, sneezing, and runny nose. The product is presented in a dosage form of 10 softgels.

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:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes use during treatment and for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

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

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 recommended dosage, which is a maximum of 4 doses within a 24-hour period. Patients should be cautioned against using this product in conjunction with other medications containing acetaminophen, as well as against the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, 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 advised to consult a physician promptly.

Healthcare professionals must emphasize the importance of avoiding overdose, as exceeding the recommended dosage can result in serious health complications. In the event of an overdose, immediate medical attention is crucial; patients should be instructed to contact a Poison Control Center without delay, regardless of the presence of symptoms.

General precautions should be taken for patients with specific health conditions. Patients should consult a physician prior to use if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing issues, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before use.

Patients should also be advised to consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Instruct patients to seek emergency medical help in the event of an overdose. Furthermore, they should be advised to discontinue use and contact their healthcare provider if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs alongside a rash or persistent headache, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed four doses in a 24-hour period, use it in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should also be cautioned about the risk of marked drowsiness, which may occur, particularly when combined with alcohol, sedatives, or tranquilizers. Excitability has been reported, especially in children, and patients are advised to avoid alcoholic beverages while using this product. Care should be taken when driving or operating machinery due to the potential for drowsiness.

Patients are advised to seek medical attention if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, or if redness or swelling is observed. New symptoms or a recurrence of cough accompanied by rash or a headache that lasts should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

In cases of overdose, which can lead to serious health complications, patients must seek immediate medical help or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is not recommended 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, and Parkinson's disease.

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

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

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

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 not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is to swallow 2 softgels with water every 6 hours.

Caution is advised as excitability may occur, particularly in children.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. 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 general considerations associated with aging and the potential for altered pharmacokinetics and pharmacodynamics.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients who consume three or more alcoholic drinks daily should refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dose of the 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.

Importance of Prompt Medical Attention

Quick medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are immediately apparent. Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of significant health risks associated with an overdose.

In summary, vigilance and prompt action are essential in managing potential overdose situations to mitigate health risks effectively.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

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 advised to stop use and consult a doctor if a cough recurs or is accompanied by a rash or a persistent headache, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery due to the potential for drowsiness. The use of alcohol, sedatives, and tranquilizers may exacerbate 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 cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Additionally, patients with difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use. Finally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also 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, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

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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