Severe Cold and Flu Relief

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough, sore throat, headache, nasal congestion, minor aches and pains, sinus congestion and pressure, sneezing, and runny nose (for nighttime use only). It aids in clearing nasal passages and provides cough relief to facilitate sleep. Additionally, it helps to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive during the daytime. This drug also temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets orally every 4 hours as needed. It is essential that the caplets are swallowed whole; they should not be crushed, chewed, or dissolved. The maximum allowable dosage is 10 caplets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician before administration.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

• In individuals with a known allergy to this product or any of its ingredients, as this may result in severe allergic reactions.

• Simultaneous use of DAYTIME and NIGHTTIME products is contraindicated to avoid potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also induce severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a physician if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have any of the following conditions: liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma (specifically for nighttime use), a cough associated with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should consult a healthcare provider or pharmacist if they are taking warfarin, a blood-thinning medication, or sedatives/tranquilizers, particularly for nighttime use.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if new symptoms arise; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires 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 concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately. Additionally, if 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.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than seven days, if new symptoms arise, if fever worsens or persists beyond three days, or if redness or swelling is observed. A return of cough or occurrence of cough with rash or headache that lasts may indicate a serious condition requiring medical evaluation.

During use, particularly at nighttime, patients may experience excitability, marked drowsiness, and should avoid alcoholic beverages. Caution is advised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with pre-existing conditions such as liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma (specifically at nighttime), or those experiencing a cough with excessive phlegm or difficulty urinating due to prostate enlargement should consult a doctor prior to use. Additionally, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product.

Patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers (especially at nighttime) should also consult a healthcare professional before use.

In cases of overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. In children, particularly during nighttime administration, excitability may occur, and marked drowsiness is also a potential side effect. For patients aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older, due to the increased likelihood of comorbidities and the potential for adverse effects. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have a history of liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma, or respiratory conditions such as asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty in urination due to prostate enlargement or persistent cough associated with smoking should seek medical advice before use.

Geriatric patients taking anticoagulants such as warfarin, or those on sedatives or tranquilizers, should also consult a healthcare professional or pharmacist prior to using this product, as interactions may occur.

When using this product, elderly patients must adhere strictly to the recommended dosage to avoid excitability, which may be more pronounced in children but can also affect older adults. Marked drowsiness is a potential side effect, and patients should avoid alcoholic beverages, as well as activities requiring alertness, such as driving or operating machinery, due to the risk of increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Elderly patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if new symptoms arise; if fever worsens or lasts more than 3 days; if redness or swelling occurs; or if cough recurs with a rash or headache lasting longer than usual. These symptoms may indicate a serious underlying condition that requires medical attention.

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, 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 regarding 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 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 critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, it is recommended to stop use and consult a healthcare professional if any of the following occur: nervousness, dizziness, or sleeplessness; worsening or persistent pain, nasal congestion, or cough lasting more than 7 days; the emergence of new symptoms; fever that worsens or lasts more than 3 days; presence of redness or swelling; or a cough that recurs or occurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center 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 initially apparent.

Additionally, healthcare providers should instruct patients not to take DAYTIME and NIGHTTIME products simultaneously. This guidance is important to ensure the safe and effective use of these medications.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). For proper inventory management, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. It is important to swallow the caplets whole and not to crush, chew, or dissolve them. For children under 12 years, a healthcare professional should be consulted for appropriate dosing.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, advising them to consult a health professional before use. Additionally, it is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is necessary for both adults and children, even in the absence of symptoms. Patients should also be cautioned against taking DAYTIME and NIGHTTIME products simultaneously. For information on teen medicine abuse, resources are available at www.StopMedicineAbuse.org.

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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