Severe Nighttime

Description

CVS Health™ Severe Nighttime Cold & Flu Relief is a maximum strength formulation designed to alleviate symptoms associated with colds and flu. The active ingredients include acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; doxylamine succinate, an antihistamine; and phenylephrine HCl, a nasal decongestant. This product effectively relieves aches, fever, sore throat, cough, sneezing, runny nose, and nasal/sinus congestion and pressure. The formulation is alcohol-free and presented in a berry flavor. Each bottle contains 8 fluid ounces (237 mL).

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, sinus congestion and pressure, headache, minor aches and pains, fever, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation. Additionally, it aids in promoting sleep by addressing cough and reduces swelling of the nasal passages, thereby facilitating nasal and/or sinus drainage and restoring freer breathing through the nose.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum limit of 4 doses within a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should emphasize the importance of not exceeding the maximum dosage to avoid potential overdose, as detailed in the Overdose warning.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are used for certain psychiatric conditions and Parkinson’s disease, and their interaction with this product may lead to serious adverse effects. Verify with a healthcare professional if there is uncertainty regarding MAOI use.

• In individuals with a known history of allergic reactions to this product or any of its components, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken for patients with the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, excessive phlegm production, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, persistent or chronic cough (e.g., due to smoking, asthma, or emphysema), or those on a sodium-restricted diet. Additionally, patients should consult a doctor or pharmacist prior to use if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, 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 alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, 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 experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or a breathing problem such as emphysema or chronic bronchitis should consult a healthcare provider. Additionally, those with trouble urinating due to an enlarged prostate gland or persistent cough associated with smoking, asthma, or emphysema, as well as individuals on a sodium-restricted diet, should seek medical advice prior to use.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. It is recommended to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, since alcohol, sedatives, and tranquilizers may enhance drowsiness.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

Caution is advised when considering the use of this medication in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric disorders, or Parkinson’s disease. It is recommended to seek guidance from a healthcare provider if the patient is currently taking an MAOI or has discontinued an MAOI within the past two weeks.

The concomitant use of this medication with warfarin, an anticoagulant, may elevate the risk of bleeding. Monitoring of coagulation parameters is advisable to ensure patient safety.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may potentiate drowsiness. Patients should be cautioned about the potential for increased sedation and advised to exercise caution when engaging in activities that require alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Nighttime (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 before use. The medication is contraindicated in children under 4 years of age. Caution is advised as excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect that may affect children.

In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

For dosing, adults and children aged 12 years and older may take 30 mL every 4 hours. For children aged 4 to under 12 years, a healthcare provider should be consulted for appropriate dosing recommendations.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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 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 on 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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

Overdosage

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 for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use due to potential teratogenic effects.

Excitability may occur, particularly in children, alongside marked drowsiness. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

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

Additionally, reports indicate that excitability may occur, particularly in pediatric populations. Marked drowsiness has also been noted, with the potential for increased sedation when acetaminophen is used in conjunction with alcohol, sedatives, or tranquilizers.

Healthcare professionals are advised to recommend discontinuation of acetaminophen and consultation with a physician if patients experience worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or persists beyond 3 days; the presence of redness or swelling; the emergence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting an extended period. These symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

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 about the presence of acetaminophen in their medications, they should 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 have stopped taking an MAOI within the past two weeks. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. They should also be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Healthcare providers should counsel patients to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 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 to seek medical attention if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

Patients should be reminded 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 against consuming alcoholic beverages while using this product. They should also exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Before using this product, patients should be advised to consult a doctor 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, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough related to smoking, asthma, or emphysema. Patients on a sodium-restricted diet or 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 a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians should counsel patients to exercise caution when driving or operating machinery, as the medication may cause drowsiness, especially when combined with alcohol, sedatives, or tranquilizers.

Patients are advised to seek medical attention if they experience worsening symptoms such as increased pain, nasal congestion, or cough lasting more than 7 days, fever persisting beyond 3 days, or the presence of redness or swelling. New symptoms, a returning cough, or a cough accompanied by a rash or headache that lasts should also prompt a consultation, as these may indicate a serious condition. Patients must adhere strictly to the dosing instructions, using only the provided dose cup and not exceeding 4 doses within a 24-hour period.

Drug Information (PDF)

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

View product document (PDF)