Severe Cold and Flu Nighttime Honey

Description

767L-Kroger-Severe Cold and Flu Nighttime Honey is a pharmaceutical formulation designed to alleviate symptoms associated with severe cold and flu. The product is presented in a liquid dosage form, specifically formulated for nighttime use. It is characterized by its honey flavor, which may enhance palatability. The formulation is intended to provide relief from symptoms such as cough, congestion, and discomfort, facilitating improved rest during the night.

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 and utilize the dose cup provided for accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period.

For children aged 6 to under 12 years, the appropriate dosage is 15 mL every 4 hours, also not to exceed 4 doses in a 24-hour timeframe.

The medication is not recommended for children aged 4 to under 6 years unless specifically directed by a healthcare professional. Additionally, it is contraindicated for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. 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, a healthcare professional should be consulted prior to use.

This product should not be used to induce sleepiness in children.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if an adult exceeds 4 doses (30 mL each) within a 24-hour period, or if a child exceeds 4 doses (15 mL each) in the same timeframe. Additionally, the risk is heightened when acetaminophen is taken concurrently with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding patients presenting with a severe sore throat. If the sore throat persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, as timely intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and consult their healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the recommended dosage of acetaminophen. Adults should not take more than 4 doses (30 mL each) within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is heightened if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the possibility of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical advice should be sought. Patients should also seek medical attention if redness or swelling occurs, new symptoms develop, or if a cough recurs alongside a rash or headache that persists.

Patients with pre-existing conditions should consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or a cough associated with excessive phlegm. Those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult 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 conditions such as depression, psychiatric disorders, or Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI. This combination may lead to serious adverse 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 potential interactions may affect anticoagulation control.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 15 mL every 4 hours, with a maximum of 4 doses (15 mL each) in a 24-hour period. For children aged 4 to under 6 years, use is not recommended unless directed by a healthcare professional. The medication is contraindicated in children under 4 years of age.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect that may affect this population.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met:

• Adults should not exceed 4 doses (30 mL each) in a 24-hour period, which is the maximum daily amount for this product.

• Children should not exceed 4 doses (15 mL each) in a 24-hour period, which is also the maximum daily amount for this product.

• Caution is advised if this product is taken concurrently with other medications containing acetaminophen, as this may increase the risk of liver damage.

• Adults who consume 3 or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage.

It is essential for healthcare providers to assess liver function and consider these factors when prescribing this product to patients with compromised liver function. Regular monitoring of liver enzymes may be warranted in these patients to ensure safety and prevent potential adverse effects.

Overdosage

Severe liver damage may occur in cases of overdosage, particularly under specific circumstances.

Adult Overdosage An adult is at risk of severe liver damage if they consume more than 4 doses (30 mL each) within a 24-hour period, which exceeds the maximum daily recommended amount for this product. Additionally, concurrent use of this product with other medications containing acetaminophen significantly increases the risk of liver toxicity.

Pediatric Overdosage For children, the risk of severe liver damage arises when more than 4 doses (15 mL each) are taken within a 24-hour timeframe, surpassing the maximum daily dosage recommended for pediatric patients.

Alcohol Consumption Adults who consume 3 or more alcoholic drinks daily while using this product are also at an elevated risk for liver damage.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare professionals should monitor liver function and consider appropriate management strategies based on the severity of the symptoms presented.

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 drug contains acetaminophen, they should consult a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this medication to induce sleepiness in children. They should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults. They should also be alert to worsening fever lasting more than three days, the presence of redness or swelling, or the emergence of new symptoms. If a cough recurs or is accompanied by a rash or persistent headache, patients should seek medical attention, as these may indicate a serious condition.

When using this product, patients must adhere strictly to the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should avoid consuming alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery.

Patients should be advised to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or a cough associated with excessive phlegm. They should also seek medical advice if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if they experience difficulty urinating due to an enlarged prostate gland. Furthermore, patients should consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to store the product at a temperature not exceeding 25℃. Refrigeration is not recommended. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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