Severe Cold and Flu Relief

Description

This formulation contains acetaminophen (325 mg) as a pain reliever and fever reducer, dextromethorphan HBr (10 mg) as a cough suppressant, guaifenesin (200 mg) as an expectorant, and phenylephrine HCl (5 mg) as a nasal decongestant. It is indicated for individuals aged 6 years and older and is classified as a maximum strength, non-drowsy medication. The product is tamper evident; do not use if the printed safety seal around the dosage cup or under the cap is broken or missing. This product is manufactured by PL Developments, located at 11865 S Alameda St, Lynwood, CA 90262. 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 drug 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 cough 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 not recommended for use in children under 4 years of age.

Healthcare professionals should instruct patients to measure the dosage using the dosing cup provided with the product, as accuracy is critical. It is important to emphasize that no other dosing devices should be used to ensure proper dosing. Additionally, when using other Daytime or Nighttime products, patients must carefully read each label to confirm 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, the 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 uncertainty about whether a prescription medication contains an MAOI, it is essential to seek guidance from a healthcare professional before using this product.

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 following conditions are met: adults exceed 4 doses (30 mL each) of acetaminophen within a 24-hour period, children exceed 4 doses (15 mL each) in the same timeframe, the product is taken concurrently with other medications containing acetaminophen, or adults consume 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blistering, or rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare provider promptly.

General Precautions Prior to use, patients should be advised to consult a healthcare professional 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 associated with excessive phlegm, or a 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 doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, even if no signs or symptoms are apparent.

Discontinuation of Use Patients should stop taking this product and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; 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 or is accompanied by 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 who exceed the recommended dosage of acetaminophen. Adults should not take more than 4 doses (30 mL each) within a 24-hour period, while children should not exceed 4 doses (15 mL each) in the same timeframe. The risk of liver damage is further increased if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an 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.

A sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than 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 is observed; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Prior to using acetaminophen, patients should consult a healthcare professional if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals on a sodium-restricted diet should seek medical advice before use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using acetaminophen.

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 present.

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 the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. The 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 6 to under 12 years may be administered 15 mL every 4 hours. For 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 associated with the use of this medication; if a child takes more than 4 doses (15 mL each) within a 24-hour period, medical advice should be sought. Additionally, caregivers should be instructed to stop use and consult a doctor if the child's pain, nasal congestion, or cough worsens or persists for more than 5 days.

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

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 individuals 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 imperative that patients do not exceed the following maximum daily doses: adults should not take more than 4 doses (30 mL each) of acetaminophen in a 24-hour period, while 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 should refrain from using this product, as alcohol can exacerbate the potential for liver damage.

In the event of an overdose, which may occur if the recommended dose is exceeded, 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 crucial 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 cases 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 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 limits the assessment of potential risks associated with the compound in these areas.

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 that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose can lead to serious 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 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 be encouraged to consult a doctor or pharmacist.

It is important to caution patients against using 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 advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in 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 accompanied by a rash or persistent headache may indicate a serious condition, warranting immediate medical attention.

While using this product, patients must be reminded not to exceed 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, difficulty urinating due to an enlarged prostate gland, a cough with excessive phlegm, a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if they are on a sodium-restricted diet. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from 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 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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