Kroger Nighttime Cold and Flu Softgel

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two Softgels taken with water every six hours as needed.

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

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

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. Ensure that the product is kept out of reach of children to prevent potential harm. No other contraindications have been identified.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 4 doses within a 24-hour period. Patients should be cautioned against the concurrent use of other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any skin reaction occurs, 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 advised to consult a physician promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a healthcare professional. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to verify with a healthcare provider or pharmacist if they are unsure about the presence of an MAOI in their prescription drugs. Furthermore, this product is not intended to induce sleep in children.

Patients should consult a healthcare professional before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Those experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

Healthcare professionals should advise patients to consult a doctor or pharmacist before using this product if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

While using this product, patients must not exceed the directed dosage. It is important to note that excitability may occur, particularly in children, and marked drowsiness may be experienced. Patients should be cautioned to avoid alcoholic beverages and to exercise caution when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should discontinue use and seek medical advice if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

For pregnant or breastfeeding patients, it is essential to consult a healthcare professional before use.

In the event of an overdose, which can lead to serious health complications, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek medical help right away (1-800-222-1222), even if no signs or symptoms are apparent, as prompt intervention is crucial for both adults and children.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within 24 hours, take the product in conjunction with other medications containing acetaminophen, 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 should also be cautioned regarding the risk of severe sore throat. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, medical attention should be sought promptly.

While using this product, excitability may occur, particularly in children, and marked drowsiness is a possibility. Patients are advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery. The concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a healthcare provider if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or occurs alongside a rash or headache that lasts. These symptoms could indicate a serious condition.

In cases of overdose, which can lead to serious health complications, 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

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) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI. This interaction may lead to serious and potentially life-threatening side effects.

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.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding or other adverse effects.

It is important to note that the consumption of alcohol, along with sedatives and tranquilizers, may further increase drowsiness and should be approached with caution.

Packaging & NDC

Below are the non-prescription pack sizes of Kroger Nighttime Cold and Flu Softgel (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). 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 product is not recommended for children under 4 years of age. For dosing, adults and children aged 12 years and older may take 2 Softgels with water every 6 hours, with a maximum of 4 doses in a 24-hour period. Caution is advised as excitability may occur, particularly in pediatric patients.

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 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 have not been specifically addressed in the available data 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 the lack of information necessitates careful clinical judgment and monitoring.

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 four doses within a 24-hour period, as this represents the maximum daily amount for this product. Additionally, patients should avoid concomitant use with other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks daily while using this product.

Before initiating treatment, patients with a history of liver disease are advised to consult a healthcare professional. During the course of treatment, it is recommended that patients refrain from consuming alcoholic beverages to mitigate the risk of liver injury.

Patients should discontinue use and seek medical advice if any of the following occur: worsening pain or cough lasting more than seven days, fever that worsens or persists for more than three days, the presence of redness or swelling, the emergence of new symptoms, 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 prompt medical evaluation.

Overdosage

In the event of an overdose, it is imperative to recognize that exceeding the recommended dosage can lead to serious health complications. Healthcare professionals should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Recommended Actions Prompt medical attention is crucial for both adults and children. It is important to emphasize that even in the absence of noticeable signs or symptoms, children should be evaluated by a healthcare professional following an overdose.

Potential Symptoms While specific symptoms of overdose may vary depending on the substance involved, the potential for serious health issues necessitates a cautious approach. Healthcare providers should remain vigilant and prepared to assess and manage any symptoms that may arise.

Management Procedures Upon identification of an overdose, healthcare professionals should initiate appropriate management protocols, which may include supportive care and symptomatic treatment. Continuous monitoring of the patient’s condition is essential to address any complications that may develop.

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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

Severe skin reactions have been reported in association with acetaminophen use, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been documented, indicating that exceeding the recommended dosage can lead to serious health complications. In instances of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

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, maintaining a temperature range between 20-25 °C (68-77 °F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, advising them to consult a health professional prior to use. Additionally, information regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org. No further details are available regarding laboratory tests or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)