Night Time Cold and Flu

Description

This product is formulated to provide multi-symptom relief for cold and flu symptoms during nighttime. It contains the following active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and doxylamine succinate, an antihistamine. The product is intended for use by individuals aged 12 years and older.

The formulation includes 10% alcohol and is available in fluid ounces (FL OZ) and milliliters (mL). It is important to note that the product is tamper evident; it should not be used if the printed safety seal around the dosage cup or under the cap is broken or missing. This product is distributed by The Kroger Co., located in Cincinnati, Ohio 45202.

Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Company is not affiliated with The Kroger Co. or this product. For more information, visit www.kroger.com.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines to avoid potential overdose. The maximum allowable dosage is 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 the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times.

Children under 12 years of age should not use this product. When using other Day Time or Night Time formulations, it is essential to read each label carefully to confirm the correct dosing to prevent unintentional overdose.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, or within 2 weeks of discontinuing such medication. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg in a 24-hour period, using it in conjunction with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should be instructed to 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 advised to consult a physician promptly.

Patients 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. It is essential for patients to verify with their healthcare provider or pharmacist if they are uncertain whether their prescription medication contains an MAOI. Additionally, this product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare professional if any of the following occur: pain or cough worsens or lasts more than seven days; new symptoms develop; fever worsens or lasts more than three days; redness or swelling is observed; 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.

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. In addition, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use immediately and seek medical assistance.

Patients should also be cautious of the potential for excitability, particularly in children, and marked drowsiness, which may impair the ability to drive or operate machinery. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and therefore, it is advisable to avoid alcoholic beverages while using this product.

Patients are advised to stop use and consult a healthcare professional if pain or cough worsens or persists for more than 7 days, if new symptoms arise, if fever worsens or lasts more than 3 days, if redness or swelling is observed, or if cough recurs with a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

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

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within two weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Caution is advised when this medication is used in conjunction with sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking these types of medications.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional before using this medication, as potential interactions may affect anticoagulation control.

The use of alcohol, sedatives, and tranquilizers in combination with this medication may enhance drowsiness. Monitoring for increased sedation is recommended in patients who are concurrently using these substances.

Packaging & NDC

Below are the non-prescription pack sizes of Night Time Cold and Flu (acetaminophen, dextromethorphan hydrobromide, 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. When administered, excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect.

In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Geriatric Use

Elderly patients may not require specific dosage adjustments for the product; however, caution is advised due to the potential for increased sensitivity to side effects. The product is intended for use in adults and children aged 12 years and older, which suggests that its safety and efficacy in geriatric patients have not been established without prior consultation with a healthcare professional.

Particular attention should be given to the sedative effects of doxylamine succinate, as elderly patients may be at an elevated risk for adverse reactions. It is recommended that geriatric patients consult with their healthcare provider before initiating use, especially if they have pre-existing health conditions or are concurrently taking other medications. Monitoring for side effects is prudent in this population to ensure safe and effective use of the product.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 be aware of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a dosage of 4,000 mg in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to using this product. In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at increased risk for liver damage. Immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe liver injury and to ensure appropriate care is provided.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their prescription includes an MAOI, they should consult with a doctor or pharmacist prior to use.

It is important to counsel patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. Patients should be encouraged to verify the presence of acetaminophen in their medications by consulting a healthcare professional if they are unsure.

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

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned to avoid alcoholic beverages while using this product, as well as to exercise caution when driving or operating machinery. The combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness.

Patients with liver disease, glaucoma, a cough associated with excessive phlegm, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema should be advised to consult a doctor before using this product. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland, as well as patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should also seek guidance from a healthcare professional 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 temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

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 important to keep the medication out of reach of children.

Drug Information (PDF)

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

View product document (PDF)