Cold and Flu Nighttime Severe

Description

24/7 Cold & Flu Nighttime Severe is a combination medication formulated to relieve multiple symptoms associated with cold and flu. Each dosage form consists of 16 caplets containing the following active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; doxylamine succinate, an antihistamine; and phenylephrine HCl, a nasal decongestant. This formulation is designed to alleviate headache, fever, sore throat, minor aches and pains, nasal congestion, sinus pressure, sneezing, runny nose, and cough.

The product is distributed by 7-Eleven, Inc., located in Irving, TX 75063, and is available for purchase at various retail locations. A tamper evident warning is included, advising users not to use the product if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. It is important to note that this product is not manufactured or distributed by The Procter & Gamble Company, and Vicks, NyQuil, and VapoCOOL™ are trademarks of The Procter & Gamble Company.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, sinus congestion and pressure, sore throat, fever, headache, nasal congestion, and cough due to minor throat and bronchial irritation. Additionally, it aids in reducing cough to facilitate sleep, as well as addressing runny nose and sneezing.

This formulation also reduces swelling of the nasal passages, promotes nasal and/or sinus drainage, and temporarily restores 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 recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets within a 24-hour period.

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

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, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

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 blisters, rash, or skin reddening. 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 sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, glaucoma, high blood pressure, difficulty urinating due to prostate enlargement, or respiratory issues such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients should consult a doctor or pharmacist before use if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help, regardless of whether symptoms are present.

Patients should 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 develop; or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly 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. Additionally, patients should be aware of the risk of severe skin reactions, which may manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients 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.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than seven days, if fever worsens or persists beyond three days, or if new symptoms arise. The presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache, may indicate a serious condition requiring medical evaluation.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery.

Patients should not exceed the recommended dosage and are encouraged to consult a healthcare provider prior to use if they have a history of liver disease, diabetes, thyroid disease, heart disease, glaucoma, high blood pressure, difficulty urinating due to prostate enlargement, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema. Additionally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product.

Drug Interactions

Concurrent use of this medication with other products 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) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects, including hypertensive crises.

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 and potential impairment.

Additionally, caution is advised for patients taking the anticoagulant warfarin. The interaction may increase the risk of bleeding; therefore, monitoring of coagulation parameters is recommended.

Alcohol, sedatives, and tranquilizers may further potentiate drowsiness when used in conjunction with this medication. It is advisable to avoid the consumption of alcohol and to use caution when engaging in activities requiring alertness.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect that should be considered. It is essential to keep the product out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information available 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 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 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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the 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 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 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use with other medications that contain acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 effects have been identified in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details, nor does the animal pharmacology and toxicology section contain relevant information.

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. These reactions can manifest as symptoms including blisters, rash, and skin reddening. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

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 critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Therefore, patients should be cautioned to avoid alcoholic beverages, as well as to exercise caution when driving a motor vehicle or operating machinery, given the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Patients should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be instructed to stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, or if any redness or swelling is observed. New symptoms that arise should also prompt a consultation with a healthcare provider. Patients should be particularly vigilant if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

Before initiating use, patients should be encouraged to consult a doctor if they have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, glaucoma, high blood pressure, difficulty urinating due to prostate enlargement, or any breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek medical guidance if they have a cough accompanied by excessive phlegm (mucus).

Lastly, patients should be reminded to consult a doctor or pharmacist prior to use if they are currently taking sedatives or tranquilizers, or if they are on the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). For proper identification, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients on important safety measures, including the necessity of consulting a health professional if pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is vital for both adults and children, regardless of the presence of symptoms.

Additionally, clinicians should be aware of the potential for medicine abuse among teens and can refer to www.StopMedicineAbuse.org for further information. No further details are available regarding laboratory tests or postmarketing experience.

Drug Information (PDF)

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

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