Cold and Flu Relief

Description

This formulation contains Acetaminophen 650 mg, a pain reliever and fever reducer; Dextromethorphan HBr 30 mg, a cough suppressant; and Diphenhydramine Succinate 12.5 mg, an antihistamine. It is intended for use by individuals aged 12 years and over. The product is presented in a liquid dosage form with a cherry flavor and contains 10% alcohol. The volume is specified in fluid ounces (FL OZ) and milliliters (mL).

This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company. The packaging includes a tamper-evident feature; do not use if the printed safety seal around the dosage cup or under the cap is broken or missing. It is distributed by Winco Foods, LLC, located in Boise, ID 83704.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, fever, sore throat, 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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

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, as an overdose may lead to serious health risks.

For children under 12 years of age, the product is not recommended and should not be used.

Patients must measure the dosage using the dosing cup provided with the product; the use of any other dosing device is not advised to ensure accurate measurement. It is also essential to keep the dosing cup with the product to facilitate proper administration.

When utilizing other Day Time or Night Time products, patients should carefully read each label to confirm correct dosing and avoid potential interactions or overdosing.

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

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems or chronic cough related to smoking, asthma, chronic bronchitis, emphysema, difficulty urinating due to an enlarged prostate gland, or if they are on a sodium-restricted diet. Additionally, patients should be cautioned to seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if any of the following occur: worsening pain or cough lasting more than seven days, the emergence of new symptoms, fever worsening or lasting more than three days, presence of redness or swelling, or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are present.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical assistance promptly.

In addition, patients should 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 patients are advised to avoid alcoholic beverages while using this product.

Patients should consult a doctor if sore throat symptoms are severe, persist for more than two days, or are accompanied by fever, headache, rash, nausea, or vomiting. Furthermore, medical advice should be sought if pain or cough worsens or lasts longer than seven days, if new symptoms arise, if fever persists for more than three days, or if redness or swelling is observed. A return of cough accompanied by rash or headache that lasts may indicate a serious condition.

Overall, careful monitoring of symptoms and adherence to recommended dosages are essential to minimize the risk of serious adverse reactions associated with 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 interaction may lead to serious adverse effects, including hypertensive crises.

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, caution is advised for patients taking warfarin or other anticoagulants. It is recommended that these patients seek guidance from a healthcare provider before initiating this medication, as potential interactions may affect anticoagulation control.

The combined use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness and should be approached with caution. Monitoring for excessive sedation is advised in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Relief (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 medication. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is a potential side effect. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns based on the available information. However, it is important to consider general factors when prescribing this product to geriatric patients.

The product is indicated for use in adults and children aged 12 years and older, suggesting that it may not be appropriate for individuals under 12. While there are no explicit guidelines for geriatric patients, caution is advised due to potential health considerations.

Elderly patients should be advised to consult a healthcare provider prior to use, particularly if they have liver disease, as this condition may pose additional risks. Furthermore, marked drowsiness is a possible side effect, which may be of heightened concern for elderly patients who often exhibit increased sensitivity to such effects.

Additionally, the concurrent use of alcohol, sedatives, or tranquilizers can exacerbate drowsiness, a factor that should be carefully evaluated in geriatric patients who may be using these substances.

Finally, it is crucial to exercise caution when driving or operating machinery, as elderly patients may be more vulnerable to drowsiness and decreased alertness, potentially impacting their ability to perform these activities safely. Regular monitoring and assessment of these factors are recommended to ensure the safe use of the product 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure appropriate management and monitoring of their condition, as reduced kidney function may influence the pharmacokinetics and safety profile of the medication.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The active ingredient, acetaminophen, poses a risk of severe liver damage if the dosage exceeds 4,000 mg within a 24-hour period. Additionally, the risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications that also contain acetaminophen.

Patients who consume three or more alcoholic beverages daily are at an increased risk of severe liver damage when using this product. It is crucial for patients with compromised liver function to adhere strictly to the recommended dosage, as exceeding this may lead to overdose and subsequent liver damage.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Monitoring of liver function may be warranted in patients with existing liver disease to mitigate the risk of adverse effects.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Importance of Prompt Action

Quick medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are initially apparent. Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of significant harm, and timely intervention can be vital in preventing severe complications.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

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

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised 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 cautioned 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 may also be a side effect. They should be advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should exercise caution when driving or operating machinery.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema. Patients with difficulty urinating due to an enlarged prostate gland or those on a sodium-restricted diet should also seek medical advice prior to use. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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