Cold and Flu Plus Congestion

Description

equate™ is a nighttime severe vapor chilling formulation designed to relieve symptoms associated with cold and flu, including headache, fever, sore throat, minor aches and pains, nasal congestion, sinus pressure, sneezing, runny nose, and cough. The product contains the following active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; doxylamine succinate, an antihistamine; and phenylephrine HCl, a nasal decongestant. It is indicated for use in individuals aged 12 years and older. The product is available in a volume of 12 fluid ounces (355 mL) and is distributed by Walmart Inc., Bentonville, AR 72716. This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® NyQuil® VapoCOOL® Severe Cold & Flu + Congestion.

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, nasal congestion, sore throat, headache, minor aches and pains, and cough, which may assist in promoting sleep. Additionally, it addresses sinus congestion and pressure, as well as cough resulting from minor throat and bronchial irritation.

This drug also temporarily reduces fever, decreases swelling of nasal passages, and restores freer breathing through the nose. Furthermore, it promotes nasal and/or sinus drainage.

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 dose is 30 mL administered every 4 hours as needed. It is imperative that patients do not exceed 4 doses within a 24-hour period.

Patients must utilize only the dose cup provided with the medication to ensure accurate dosing.

The use of this medication is not recommended for 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, or 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 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 in a 24-hour period, uses this product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as blisters, rash, or skin reddening. If any skin reaction occurs, patients should discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare provider promptly.

General Precautions It is imperative that patients do not exceed the recommended dosage. Excitability may occur, particularly in children. Patients should avoid alcoholic beverages, as marked drowsiness may result from the use of this product. The concomitant use of alcohol, sedatives, or tranquilizers may further enhance drowsiness. Caution is advised when driving or operating machinery due to the potential for drowsiness.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

When to Stop Taking the Product and Consult a Doctor Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected may indicate a serious condition requiring 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, or consume three or more alcoholic drinks daily while using this product. Additionally, patients may experience severe skin reactions, which can manifest as blisters, rash, or skin reddening. 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 they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

It is crucial for patients not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or for Parkinson’s disease, should not use this product during treatment or for two weeks following the cessation of the MAOI. Individuals with a history of allergic reactions to this product or any of its ingredients should also avoid its use.

Patients should consult a healthcare professional prior to use if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, a cough accompanied by excessive phlegm, breathing problems such as emphysema or chronic bronchitis, persistent or chronic cough (e.g., due to smoking, asthma, or emphysema), glaucoma, heart disease, high blood pressure, liver disease, thyroid disease, or diabetes. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

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 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 and potentially life-threatening interactions.

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. 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 Plus Congestion (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. In clinical observations, excitability has been noted to occur, particularly in children. For patients aged 12 years and older, the recommended dosage is 30 mL every 4 hours.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 potential adverse effects or changes in therapeutic response, 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 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 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 should use caution when using this product, as specific dosage adjustments or monitoring may be necessary based on renal function. It is advisable for patients to consult a healthcare professional before use if they experience difficulty in urination due to enlargement of the prostate gland or if they have liver disease.

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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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 should be aware that the absence of symptoms does not preclude the possibility of serious complications. 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 effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with the use of acetaminophen. Reports include symptoms such as skin reddening, blisters, and rash. These events have been documented through voluntary reporting and surveillance programs.

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 present.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned against consuming alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Providers should emphasize the need for caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. Patients should be encouraged to consult with their healthcare provider before using the medication if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, a cough accompanied by excessive phlegm, breathing problems such as emphysema or chronic bronchitis, a persistent or chronic cough related to smoking, asthma, or emphysema, glaucoma, heart disease, high blood pressure, liver disease, thyroid disease, or diabetes.

Additionally, patients should be advised to speak with their doctor or pharmacist before using the medication if they are currently taking the blood-thinning drug warfarin or if they are using sedatives or tranquilizers.

Storage and Handling

The product is supplied in accordance with the following specifications. 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).

Healthcare professionals are advised to adhere to the expiration date indicated on the package to ensure product efficacy and safety. Proper storage conditions are essential for maintaining the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)