Cold and Flu

Description

NDC 71141-180-32 is a liquid formulation containing three active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and doxylamine succinate, an antihistamine. The product is packaged in a 12 FL OZ (355 mL) container and is manufactured by LiDL®. It is designed for use by individuals aged 12 years and over. The product features a tamper-evident seal, and it should not be used if the printed neck wrap is broken or missing. This formulation is comparable to the active ingredients found in Vicks® NyQuil® Cold & Flu. It is distributed by LIDL US, LLC, located in Arlington, VA 22202, and further information can be obtained by contacting 1-844-344-5071 or visiting www.lidl.com. This product is not manufactured or distributed by The Procter & Gamble Company, the owner of the registered trademark Vicks® NyQuil® Cold & Flu.

Uses and Indications

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

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours, with a maximum of 4 doses within a 24-hour period. It is imperative that patients do not exceed this dosage.

Patients should utilize only the dose cup provided with the medication to ensure accurate measurement.

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, as well as for Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a known history of allergic reactions to this product or any of its ingredients.

Warnings and Precautions

This product contains acetaminophen, which carries a significant 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 beverages daily while using this product.

Acetaminophen may also induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any 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 severe sore throat that 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: difficulty urinating due to prostate gland enlargement, a cough associated with excessive phlegm, chronic respiratory issues such as asthma, chronic bronchitis, or emphysema, liver disease, or glaucoma. Additionally, patients should consult a doctor or pharmacist before use if they are currently taking the anticoagulant warfarin or any sedatives or tranquilizers.

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 without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare provider if they experience any of the following: worsening pain or cough lasting more than seven days, the presence of redness or swelling, a fever that worsens or persists for more than three days, the emergence of new symptoms, or a recurrence of cough accompanied by rash or 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 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while using this product. Additionally, patients may experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Patients should be aware of the warning regarding sore throat; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and patients are advised to exercise caution when driving or operating machinery.

Patients are instructed to stop use and consult a doctor if pain or cough worsens or persists beyond seven days, if redness or swelling is observed, if fever worsens or lasts more than three days, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should seek medical advice if they have difficulty urinating due to prostate enlargement, a cough accompanied by excessive phlegm, a chronic cough or breathing problem related to smoking, asthma, chronic bronchitis, or emphysema, liver disease, or glaucoma. Furthermore, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a healthcare professional prior to use.

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 2 weeks following the discontinuation of an MAOI. This combination 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 and potential respiratory depression is recommended in these cases.

Packaging & NDC

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

Pediatric Use

Children under 12 years of age should not use this product. For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Caution is advised as excitability may occur, particularly in children. It is important to keep this product out of reach of children. In the event of an overdose, prompt medical attention is critical for pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients do not have specific recommendations for geriatric use, including dosage adjustments, safety concerns, or special precautions, as outlined in the provided drug insert. Therefore, healthcare providers should consider the absence of tailored guidance 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 general considerations 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 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing 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 are advised to remain vigilant, as the absence of symptoms does not preclude the possibility of serious complications. Early recognition and management of an overdose can significantly influence patient outcomes. Therefore, it is essential to ensure that patients and caregivers are aware of the importance of timely medical evaluation in cases of suspected overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with the use of acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

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 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. Additionally, they should be instructed to discontinue use and consult a doctor if pain or cough worsens or persists for more than seven days, if redness or swelling occurs, if fever worsens or lasts more than three days, or if new symptoms arise. Patients should also be advised to seek medical attention if a cough recurs or is accompanied by a rash or headache that lasts, 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 result from its use. Patients should be informed that the combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness, and they should exercise caution when driving or operating machinery.

Patients should be encouraged to consult a doctor before using this product if they experience difficulty urinating due to an enlarged prostate gland, have a cough accompanied by excessive phlegm, or have a chronic cough or breathing problems related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with liver disease or glaucoma should seek medical advice prior to use. Lastly, 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 packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product 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 healthcare professional prior to use.

Additionally, information regarding the potential for medicine abuse, particularly among teenagers, can be found at www.StopMedicineAbuse.org. No further details are available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)