Cold and Flu

Description

This product contains three active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and doxylamine succinate, an antihistamine. It is indicated for the relief of headache, fever, sore throat, minor aches and pains, sneezing, runny nose, and cough. The formulation is flavored with eucalyptus mint and is available in a liquid dosage form, with a total volume of 12 FL OZ (355 mL).

This product is intended for use by individuals aged 12 years and over. It features a tamper-evident design, and should not be used if the printed neck wrap is broken or missing. The product is distributed by BI-MART, located in Eugene, OR 97402, and is identified by NDC 37835-524-02. It is comparable to the active ingredients found in Vicks® NyQuil® Cold & Flu; however, 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 indicated for use in children under 12 years of age; therefore, it should not be administered to this population.

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) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. Verification of MAOI content in current prescriptions should be sought from a healthcare professional if uncertain.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic drinks daily while taking this product.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be advised to consult a physician promptly.

General precautions should be taken for patients with specific medical conditions. Healthcare professionals should recommend that patients consult a doctor prior to use if they have difficulty urinating due to prostate enlargement, a cough that produces excessive phlegm, or any breathing problems such as chronic cough, asthma, chronic bronchitis, or emphysema. Additionally, patients with liver disease or glaucoma should seek medical advice before using this product.

Patients taking anticoagulants such as warfarin, or those on sedatives or tranquilizers, should also consult a healthcare provider or pharmacist before use to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

Patients should discontinue use and contact a healthcare professional if pain 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 lasting longer than expected. 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 drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, 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. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to 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 cautioned to avoid alcoholic beverages. Due to the potential for drowsiness, individuals should exercise caution when driving or operating machinery.

Patients should discontinue use and consult a doctor if pain 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 arise, or if a cough recurs with a rash or headache lasting longer than expected, 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, emphysema, liver disease, or glaucoma. Additionally, 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 any other product 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 interaction may lead to serious adverse effects, including hypertensive crises.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential interactions.

Additionally, caution is advised for individuals using sedatives or tranquilizers, as the combination may enhance the sedative effects, leading to increased drowsiness. The consumption of alcohol in conjunction with this medication, as well as with sedatives and tranquilizers, may further exacerbate drowsiness and should be avoided. Monitoring for excessive sedation 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

Pediatric patients under 12 years of age should not use this product. Caution is advised as excitability may occur, particularly in children.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use of other medications containing acetaminophen should be avoided to prevent unintentional overdose.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may significantly increase the risk of liver damage.

Additionally, patients with known liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with the use of acetaminophen: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Patients should be advised 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.

It is important to inform patients that they should not 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 consult a healthcare professional.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If patients are unsure whether their prescription includes an MAOI, they should seek clarification from a healthcare provider.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised not to use it.

Patients should be instructed to discontinue use and consult a healthcare provider if their pain or cough worsens or persists for more than seven days, if their fever worsens or lasts more than three days, if they notice any redness or swelling, or if new symptoms arise. Additionally, they should seek medical advice 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 may experience excitability, particularly in children. They should be advised to avoid alcoholic beverages, as alcohol can exacerbate drowsiness, which may also be heightened by the use of sedatives or tranquilizers. Patients should exercise caution when driving or operating machinery due to the potential for marked drowsiness.

Patients should be encouraged to consult a healthcare provider before using this product if they have difficulty urinating due to prostate gland enlargement, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, liver disease, or glaucoma. Furthermore, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should also seek advice 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 should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° 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

No additional information is available regarding laboratory tests or postmarketing experience.

Clinicians should advise patients 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. Patients who are pregnant or breastfeeding should consult a healthcare professional prior to use. Additionally, parents are encouraged to educate themselves about the potential for medicine abuse among teens by visiting www.StopMedicineAbuse.org.

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)