Severe Nighttime Cold and Flu Relief

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sore throat, headache, sinus congestion and pressure, minor aches and pains, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

Additionally, this drug temporarily reduces fever and cough to facilitate sleep, decreases swelling of nasal passages, restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is 4 doses within a 24-hour period. It is imperative to measure the dosage exclusively with the dosing cup provided; the use of any other dosing device is not recommended.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. This dosage should not be exceeded. For children under 12 years of age, the use of this medication is contraindicated.

When utilizing either the Daytime or Nighttime formulations, healthcare professionals should advise patients to carefully read each label to ensure accurate dosing. The dosing cup should be kept with the product to facilitate proper measurement.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or within 2 weeks of discontinuing an MAOI. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic beverages daily while using this product.

Patients should be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, 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 instructed to consult a physician promptly.

General precautions should be taken when considering the use of this product. Patients should be advised to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, difficulty urinating due to an enlarged prostate, a cough that produces excessive phlegm, or a history of breathing problems such as asthma, chronic bronchitis, or emphysema. Additionally, patients on a sodium-restricted diet should seek medical advice before use.

It is also important for patients to consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin, as these medications may interact with acetaminophen.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, even if no symptoms are present.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if new symptoms arise, medical consultation is necessary. Patients should also seek medical advice if fever worsens or lasts more than three days, if redness or swelling occurs, or if a cough recurs with a rash or headache that persists. These symptoms may indicate serious underlying conditions that require further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, 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 cautious of severe sore throat symptoms that persist for more than two days or are accompanied by fever, headache, rash, nausea, or vomiting, as these may require prompt medical consultation.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are advised 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 impaired alertness.

Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if new symptoms arise, medical advice should be sought. A worsening fever lasting more than three days, the presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate serious conditions requiring evaluation.

An overdose warning is also pertinent; taking more than the recommended dose can lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial even if no signs or symptoms are initially apparent.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Nighttime Cold and Flu Relief (acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 30 mL every 4 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is also a potential side effect. It is crucial to keep this medication out of reach of children to prevent accidental ingestion.

An overdose warning is applicable; taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not require specific dosage adjustments or exhibit unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution and consider the overall health status of geriatric patients when prescribing this medication.

Particular attention should be given to patients with pre-existing conditions, as it is advised that individuals consult their healthcare provider prior to use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or difficulties with urination due to an enlarged prostate gland. These conditions may be more prevalent in the elderly population and could influence the safety and efficacy of the treatment. Regular monitoring and assessment of these factors are recommended to ensure optimal care for geriatric patients.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage increases if patients take other medications containing acetaminophen or consume three or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at risk for liver damage. Immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay, as prompt medical attention is essential, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial, even if the individual does not exhibit any noticeable signs or symptoms of overdose.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious harm. Therefore, it is essential to monitor the patient closely and initiate appropriate management procedures as soon as an overdose is suspected.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other aspects of nonclinical toxicology. Additionally, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial even if no signs or symptoms are present.

Patients should be informed 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. If patients are uncertain whether their prescription medication contains an MAOI, they should consult with their doctor or pharmacist.

It is important to counsel patients against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. Patients should be encouraged to ask their healthcare provider if they are unsure about the presence of acetaminophen in their medications.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if there is any redness or swelling. Patients should also be advised to stop use and contact a doctor 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 should adhere strictly to the directed 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 cautioned to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. They should also exercise caution when driving or operating machinery.

Patients with specific health conditions should be encouraged to consult their healthcare provider before using this product. This includes individuals with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or those experiencing difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm, or those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients on a sodium-restricted diet or those taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult their doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. An overdose warning is in place, as exceeding the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential, even if no symptoms are present.

Drug Information (PDF)

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

View product document (PDF)