Nighttime Hbp Cold and Flu Relief

Description

NDC 69842-086-02. This product is a cherry-flavored liquid formulation designed for nighttime relief of high blood pressure cold and flu symptoms. It contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and doxylamine succinate, an antihistamine. The formulation is decongestant-free, making it suitable for individuals with high blood pressure. It provides multi-symptom relief for aches and fever, runny nose, sneezing, and cough. The product is intended for use by individuals aged 12 years and older and is packaged in a 12 FL OZ (355 mL) bottle. It is tamper evident; do not use if the printed neck wrap is broken or missing. This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® NyQuil™ High Blood Pressure Cold & Flu. Distributed by CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. © 2025 CVS/pharmacy. For more information, visit CVS.com® or call 1-800-SHOP CVS. V-19849.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including headache, minor aches and pains, sore throat, runny nose, sneezing, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL administered every 6 hours as needed. It is imperative that patients utilize only the dose cup provided with the medication to ensure accurate dosing.

The medication is not recommended for use in children under 12 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.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they 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 informed 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, 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: difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, respiratory issues such as chronic cough, asthma, chronic bronchitis, or emphysema, or if they experience a cough accompanied by excessive phlegm. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives/tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients must be advised to discontinue use and contact a healthcare provider if any of the following occur: pain or cough worsens or persists beyond seven days, redness or swelling develops, fever worsens or lasts more than three days, new symptoms arise, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Additionally, acetaminophen may cause 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 cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

It is recommended that patients stop using the product and consult a doctor if pain or cough worsens or lasts longer than seven days, if redness or swelling is observed, if fever worsens or persists for more than three days, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These could indicate a serious underlying condition.

While using this product, patients may experience excitability, particularly in children, and should be aware that marked drowsiness may occur. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and caution is advised when driving a motor vehicle or operating machinery.

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 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 an MAOI. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson’s disease, and their interaction with this medication may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation is recommended in these cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. In children, the use of this medication may lead to excitability. In the event of an overdose, it is crucial to seek prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. 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 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 no specific data available regarding the excretion of this medication in 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.

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 concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, 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 about the presence of acetaminophen in their medications, they should be encouraged to 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 past two weeks. Patients should be advised to check with a healthcare professional 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 cautioned against its use.

Healthcare providers should recommend that patients discontinue use and consult a doctor if pain or cough worsens or persists for more than seven days. Additionally, patients should be advised to seek medical advice if they experience redness or swelling, if fever worsens or lasts more than three days, or if new symptoms arise. Patients should also be instructed to stop use and consult a doctor if a cough recurs or is accompanied by a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children. They should be advised to avoid alcoholic beverages, as well as to be cautious of marked drowsiness that may occur. Patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should counsel patients to exercise caution when driving or operating machinery while using this product.

Patients should be encouraged to consult a doctor before use if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or any breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with a cough that produces excessive phlegm should seek medical advice prior to use.

Finally, patients taking the blood-thinning medication warfarin, as well as those on sedatives or tranquilizers, should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in accordance with the following specifications. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F).

Healthcare professionals are advised to adhere to the expiration date indicated on the package to ensure product efficacy and safety. Proper storage conditions are essential for maintaining the integrity of the product throughout its shelf life.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

Additionally, it is crucial to keep the medication out of reach of children. In the event of an overdose, patients must seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms. For information regarding the potential for medicine abuse among teens, resources are available at www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

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