Cvs Nighttime Cold

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 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 4 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours as needed.

For children aged 4 years to under 12 years, it is advised to consult a physician for appropriate dosing recommendations.

The medication is not recommended for use in children under 4 years of age.

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 a prohibition on use for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• The product should not be used in excess of the directed dosage.

• Consumption of alcoholic beverages should be avoided while using this product.

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 (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to 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. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

General precautions should be observed when using this product. It is contraindicated to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended.

This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription drug, a healthcare professional should be consulted prior to use.

Healthcare providers should be consulted before use if the patient has 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, trouble urinating due to an enlarged prostate gland, or is on a sodium-restricted diet. Additionally, patients should seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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

Patients are advised to discontinue use and consult a healthcare provider 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 that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of four doses within 24 hours, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for symptoms associated with a sore throat. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is crucial to consult a healthcare professional promptly.

Patients are instructed to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than 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 or is accompanied by a rash or headache that persists. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other medications containing acetaminophen or in individuals consuming three or more alcoholic beverages daily. It is advisable to avoid the combination of these substances to mitigate the risk of hepatotoxicity.

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious adverse effects. It is recommended to avoid the use of dextromethorphan in patients currently taking MAOIs or for a period of two weeks following the discontinuation of MAOIs to prevent potential interactions.

Warfarin, an anticoagulant, may experience altered effects when administered alongside acetaminophen. It is essential to monitor International Normalized Ratio (INR) levels closely in patients receiving this combination to ensure therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Nighttime Cold (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride). 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 using this product. The use of this product is contraindicated in children under 4 years of age.

When administered, this product may cause excitability, particularly in children. In the event of an overdose, it is crucial to seek immediate medical attention for both adults and children, even if no signs or symptoms are apparent.

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 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, as the effects on fetal outcomes and lactation 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

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the maximum recommended dosage of four doses within a 24-hour period. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of liver injury.

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

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 timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product 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 advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and consult a doctor 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 any redness or swelling occurs. Patients should also be informed to seek medical attention if new symptoms arise or if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be cautioned not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness may also be a 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. It should be emphasized that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

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 a cough with excessive phlegm. Patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, patients who have difficulty urinating due to an enlarged prostate gland or those on a sodium-restricted diet should consult their healthcare provider. Lastly, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should be advised to speak with 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, ensuring that it is not subjected to refrigeration. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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 at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)