Equate Severe Cold Multi Symptom

Description

This product contains active ingredients comparable to those found in Theraflu® Multi-Symptom Severe Cold. It includes acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and phenylephrine HCl, acting as a nasal decongestant. The formulation is designed to provide relief from nasal and sinus congestion, cough, body aches, sore throat pain, headache, and fever. The product is available in a 6-pack format and features green tea and honey lemon flavors.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including minor aches and pains, minor sore throat pain, headache, nasal and sinus congestion, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The standard dosing for adults and children aged 12 years and older is one packet every 4 hours, as needed, while symptoms persist. It is imperative not to exceed 6 packets within a 24-hour period unless directed by a healthcare professional.

For administration, the contents of one packet should be dissolved in 8 ounces of hot water. The solution should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes for optimal effectiveness.

If a microwave is used for preparation, the contents of one packet should be added to 8 ounces of cool water. The mixture must be stirred briskly before and after heating to ensure proper dissolution. Care should be taken not to overheat the solution.

This product is not recommended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• In children under 12 years of age.

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

• Concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is advised.

• 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 uncertainty about the presence of an MAOI in a prescription medication, consultation with a doctor or pharmacist is recommended.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate an allergic reaction. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

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 advised to consult a physician promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, a cough associated with excessive phlegm, or a chronic cough related to smoking, asthma, or emphysema. Additionally, those on a sodium-restricted diet should seek medical advice before use. It is also important to consult a doctor or pharmacist if the patient is taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms develop; or if pain, cough, or nasal congestion worsens or lasts more than seven days. Additionally, if a cough recurs or is accompanied by a rash or headache that persists, these may be indicative of a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur 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 potential for severe skin reactions associated with acetaminophen, 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.

In cases where 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.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if pain, cough, or nasal congestion worsens or persists for more than seven days. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, these may indicate a serious condition requiring medical evaluation.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should seek medical advice. Patients with a cough that produces excessive phlegm, or a chronic cough associated with smoking, asthma, or emphysema, should also consult a healthcare provider. Those on a sodium-restricted diet should inquire about the use of this product.

Patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication, due to the potential for increased bleeding risk.

Co-administration with any other product containing acetaminophen, whether prescription or over-the-counter, is contraindicated. Patients are advised to verify the presence of acetaminophen in any other medications they are taking by consulting a healthcare professional.

The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Patients uncertain about whether their prescription includes an MAOI should seek guidance from a healthcare professional before using this product.

Packaging & NDC

Below are the non-prescription pack sizes of Equate Severe Cold Multi Symptom (acetaminophen, dextromethorphan hbr, 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. For those 12 years and older, the recommended dosage is one packet. There are no established safety or efficacy profiles for children under 12, and use in this population is contraindicated.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 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 that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function 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 at 1-800-222-1222. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that medical personnel monitor the patient closely and provide supportive care as needed.

In cases of suspected overdose, the following steps should be taken:

1. Assessment: Evaluate the patient's condition, including vital signs and level of consciousness.

2. Supportive Care: Administer appropriate supportive measures, which may include intravenous fluids, oxygen supplementation, or other interventions based on the clinical presentation.

3. Poison Control Consultation: Engage with a Poison Control Center for guidance on specific management protocols and antidotes, if applicable.

Timely and effective management can significantly influence the outcome in overdose situations.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important for healthcare providers to encourage patients to consult with their doctor before using the medication if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm (mucus), a chronic cough associated with smoking, asthma, or emphysema, or if they are on a sodium-restricted diet.

Additionally, patients should be advised to speak with their doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin. This precaution is vital to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Care must be taken to protect the product from heat and moisture to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one packet every four hours as needed, not exceeding six packets within a 24-hour period unless directed by a healthcare professional. To prepare, the contents of one packet should be dissolved in 8 ounces of hot water and sipped while hot, ensuring the entire drink is consumed within 10-15 minutes. If using a microwave, the packet's contents should be added to 8 ounces of cool water, stirred briskly before and after heating, and care should be taken to avoid overheating.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)