Multi-Symptom Cold and Flu Relief Nighttime

Description

No relevant information is available for SPL code 34089-3.

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 effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

The medication should be taken only as directed. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours, not to exceed 8 softgels within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The use of this 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.

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 maximum daily dosage of 8 softgels within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider without delay.

In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to stop taking the product and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts longer than 7 days; fever worsens or persists for more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 softgels within a 24-hour period, take the product in conjunction with other medications 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.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised to stop use and contact a doctor if any of the following occur: pain or cough worsens or lasts longer than 7 days; fever worsens or lasts longer than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or occurs alongside a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with any other drug 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 taking 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 combined 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 Cold and Flu Relief Nighttime (acetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg). 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. Caution is advised as excitability may occur, particularly in pediatric populations. Marked drowsiness is also a potential side effect.

It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

For adults and children aged 12 years and older, the recommended dosage is 2 softgels with water every 6 hours.

Geriatric Use

Elderly patients may not require specific dosage adjustments or safety considerations based on the available data. However, it is important to note that the prescribing information does not provide any special precautions or recommendations tailored specifically for geriatric patients.

Healthcare providers should exercise caution and consider the potential for comorbidities when treating elderly patients, particularly those with liver disease. It is advisable for healthcare providers to consult with a physician before initiating treatment in this population to ensure appropriate management and monitoring.

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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 8 softgels within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with this product, which contains acetaminophen.

Maximum Daily Dosage Healthcare professionals should advise patients that the maximum recommended dosage is 8 softgels within a 24-hour period. Exceeding this limit significantly increases the risk of liver injury.

Concurrent Use with Other Acetaminophen Products It is essential to caution patients against the concurrent use of this product with other medications that also contain acetaminophen. Such combinations can lead to an increased risk of severe liver damage.

Alcohol Consumption Patients should be informed that the risk of liver damage is further heightened if they consume three or more alcoholic drinks daily while using this product. This interaction can exacerbate the hepatotoxic effects of acetaminophen.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should assess the patient's condition and consider the need for liver function tests and potential interventions, such as the administration of N-acetylcysteine, which may mitigate liver damage if administered promptly.

Monitoring and supportive care should be initiated as necessary, depending on the severity of the symptoms and the extent of the overdose.

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 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. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, 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 whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is essential to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. Patients should be encouraged to ask their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also seek medical advice if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients must adhere strictly to the recommended dosage and be aware that excitability may occur, particularly in children. Marked drowsiness is also a potential side effect, and patients should be cautioned against consuming alcoholic beverages while using this product. Additionally, patients should exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with liver disease, glaucoma, a cough accompanied by excessive phlegm, or breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema should consult a doctor before using this product. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland, as well as those taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek guidance from their healthcare provider or pharmacist prior to use.

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; however, standard precautions should be observed to ensure optimal storage conditions.

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. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)