Severe Cold and Flu Relief

Description

This formulation contains four active ingredients: Acetaminophen (325 mg), a pain reliever and fever reducer; Dextromethorphan HBr (10 mg), a cough suppressant; Guaifenesin (200 mg), an expectorant; and Phenylephrine HCl (5 mg), a nasal decongestant. The product is indicated for the relief of headache, fever, sore throat, minor aches and pains, nasal and sinus congestion, sinus pressure, cough, and chest congestion.

Designed for individuals aged 6 years and older, this maximum strength formulation is alcohol-free and non-drowsy. It is important to note that this product is not manufactured or distributed by The Procter & Gamble Company, and Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses nasal congestion, sinus congestion and pressure, minor aches and pains, headache, fever, sore throat, and cough due to minor throat and bronchial irritation.

Additionally, this medication reduces swelling of the nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus and making coughs more productive.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 30 mL every 4 hours, not exceeding 4 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours, also adhering to the maximum of 4 doses in a 24-hour timeframe.

For children aged 4 to under 6 years, it is essential to consult a physician before administration. The product is contraindicated for children under 4 years of age.

It is imperative that the medication is taken only as directed, and healthcare professionals should emphasize the importance of measuring the dosage with the dosing cup provided, as other dosing devices may lead to inaccuracies. The dosing cup should be kept with the product to ensure proper measurement.

When using other Daytime or Nighttime products, healthcare professionals should advise patients to carefully read each label to ensure correct dosing and avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated 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 any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Patients are also advised not to exceed the recommended dosage of this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults must not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, and children should not exceed 4 doses (15 mL each) in the same timeframe. Caution is also warranted if the product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blistering, or rash. In the event of any 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 2 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 the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, cough associated with excessive phlegm, or persistent cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals on a sodium-restricted diet should seek medical advice before use. It is also recommended that patients taking the anticoagulant warfarin consult with a healthcare provider or pharmacist prior to using this product.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, if new symptoms arise, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage. Specifically, adults should not take more than 4 doses (30 mL each) in a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes 3 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, blistering, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than 2 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. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults, or if new symptoms arise, medical advice should be sought. A worsening fever lasting more than 3 days, the presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache may indicate a serious condition requiring medical evaluation.

Before using this product, patients should consult a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Those with a cough that produces excessive phlegm or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice. Patients on a sodium-restricted diet or those taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

An overdose of acetaminophen can lead to serious liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of two weeks following the discontinuation of the MAOI. This combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in the effectiveness of warfarin therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and over may be administered 30 mL every 4 hours. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. In children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the liver warning, which indicates that a child should not take more than 4 doses of 15 mL each within a 24-hour period. Additionally, caregivers should be instructed to stop use and consult a doctor if a child's pain, nasal congestion, or cough worsens or persists beyond 5 days. For adults, the duration is 7 days.

In cases of suspected overdose, immediate medical attention is critical for pediatric patients, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments or present unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution and consider the overall health status of geriatric patients when prescribing this medication.

Before initiating treatment, healthcare providers should inquire about any existing medical conditions in elderly patients, including liver disease, heart disease, high blood pressure, thyroid disease, diabetes, urinary difficulties due to an enlarged prostate, chronic cough associated with excessive phlegm, persistent cough related to smoking, asthma, chronic bronchitis, emphysema, or adherence to a sodium-restricted diet. These factors may influence the safety and efficacy of the medication.

Additionally, it is crucial to inform elderly patients about the risks associated with overdose, as exceeding the recommended dosage can lead to serious liver damage. Prompt medical attention is necessary for adults who may experience symptoms of overdose. Regular monitoring and assessment of the patient's condition are recommended to ensure safe and effective use of the medication in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance 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 adults do not exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, and children should not exceed 4 doses (15 mL each) in the same timeframe. Additionally, patients must avoid concurrent use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. Furthermore, adults consuming 3 or more alcoholic drinks daily while using this product should also seek medical advice, as this may exacerbate the risk of liver damage.

In the event of an overdose, which can lead to serious liver damage, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Overdosage

Taking more than the recommended dose of this medication can lead to serious liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is crucial for both adults and children, even in instances where no signs or symptoms are immediately apparent. Early intervention can significantly impact the outcome and mitigate the risk of severe complications associated with overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blistering, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients that taking more than the recommended dose of this medication can lead to serious liver damage. In the event of an overdose, patients must 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 present.

Patients should be informed not to use this medication in conjunction with any other drug 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 they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days for children or 7 days for adults. New symptoms, worsening fever lasting more than 3 days, or the presence of redness or swelling should also prompt a consultation with a healthcare provider. Patients should be made aware that a returning cough or one that occurs with a rash or persistent headache may indicate a serious condition, necessitating medical attention.

While using this product, patients must be reminded to adhere strictly to the directed dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough accompanied by excessive phlegm, a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use. Furthermore, those on a sodium-restricted diet or taking the blood-thinning medication warfarin should consult a healthcare provider 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 product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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