Nighttime Severe Cold and Flu

Description

775L is a nighttime cold and flu medication formulated to alleviate symptoms associated with colds and influenza. It is designed for use during the night to help promote restful sleep while addressing common cold and flu symptoms. The product's specific formulation details, including active and inactive ingredients, dosage form, and molecular weight, are essential for healthcare professionals to understand its pharmacological properties and therapeutic applications.

Uses and Indications

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

Additionally, this drug reduces swelling of the nasal passages, temporarily 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, utilizing the dose cup provided to ensure accurate measurement. It is imperative not to exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours as needed. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is contraindicated for children under 4 years of age; therefore, use in this age group is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals 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 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product. Healthcare professionals should advise patients to adhere strictly to the recommended dosage to mitigate these risks.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative for patients to consult a healthcare provider without delay.

General precautions include keeping this product out of reach of children. 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, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, 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 develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses 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. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting for an extended period may indicate a serious condition, warranting prompt medical evaluation.

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 and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, certain psychiatric or emotional conditions, and Parkinson's disease. The combination may lead to serious adverse effects.

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

Additionally, individuals on anticoagulant therapy with 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 further increase drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional prior to use. The product is not recommended for children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 drug 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses 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.

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, as alcohol consumption can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment to ensure safety and prevent adverse effects.

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 exceeding 4 doses within a 24-hour period poses a significant risk of severe liver damage. This dosage represents the maximum daily amount recommended for safe use of this product.

Concurrent Use with Other Acetaminophen-Containing Medications The risk of severe liver damage is further heightened if this product is taken in conjunction with other medications that also contain acetaminophen. It is essential for healthcare providers to assess all medications a patient is taking to prevent unintentional overdose.

Alcohol Consumption Patients should be cautioned against the consumption of 3 or more alcoholic drinks daily while using this product, as this can also lead to severe liver damage. Healthcare professionals should evaluate a patient's alcohol intake and provide guidance on safe consumption levels during treatment.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function and implementing appropriate management strategies are crucial to mitigate the risk of severe hepatic injury.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, 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.

It is important 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 or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised 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 for more than seven days, if fever worsens or lasts more than three days, or if redness or swelling occurs. New symptoms or a recurrence of cough, especially if accompanied by a rash or persistent headache, should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, patients must 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 cautioned against consuming alcoholic beverages while using this product, as well as being careful 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 any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, emphysema, difficulty urinating due to an enlarged prostate gland, or if they are on a sodium-restricted diet. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking sedatives or tranquilizers, or if they are using the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to store the product at a temperature not exceeding 25℃. Refrigeration is not recommended. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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