Severe Cold and Flu Relief

Description

No description information is available for the drug.

Uses and Indications

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

For nighttime use, this drug is indicated to relieve cough, runny nose, and sneezing, promoting better sleep. Additionally, it reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

During daytime use, this drug helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways and making coughs more productive.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the specified limits. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, not to exceed 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician before administration.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) 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 current prescription, a healthcare professional should be consulted.

Finally, patients should not take DAYTIME and NIGHTTIME products simultaneously.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that liver damage may occur if acetaminophen is taken in conjunction with other medications containing acetaminophen, if the total daily dosage exceeds 4,000 mg, or if the patient consumes three or more alcoholic drinks daily while using this product.

Patients should be alerted to the potential for severe skin reactions associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must 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 medical conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have liver disease, diabetes, high blood pressure, glaucoma (for nighttime use), thyroid disease, heart disease, a cough associated with excessive phlegm, or a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema (for daytime use). Additionally, patients experiencing difficulty urinating due to prostate enlargement or chronic respiratory issues should seek medical advice before use.

Patients should also consult a doctor or pharmacist if they are currently taking warfarin, a blood-thinning medication, or if they are using sedatives or tranquilizers (for nighttime use).

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center 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 must be advised to discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other drugs containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using the product. Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical assistance immediately.

In clinical settings, patients experiencing 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. Participants should also be instructed to stop use and seek medical advice 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, or if new symptoms arise. Additionally, if a cough recurs or occurs with a rash or headache that lasts, these may indicate a serious condition requiring medical evaluation.

While using this product, patients should adhere to the recommended dosage to avoid adverse effects. Notably, excitability and marked drowsiness may occur, particularly in children when used at nighttime. Patients are cautioned to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness. Care should be taken when driving or operating machinery during this time.

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

Patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers (for nighttime use) should also consult a doctor or pharmacist prior to use. In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Acetaminophen has the potential to increase the risk of severe liver damage when used concurrently with other medications containing acetaminophen or when the total daily dosage exceeds 4,000 mg. It is advisable for healthcare professionals to monitor the total daily intake of acetaminophen to mitigate this risk.

The concomitant use of sedatives or tranquilizers with this product may enhance drowsiness, particularly during nighttime. Caution is recommended when prescribing these combinations, and patients should be advised on the potential for increased sedation. Monitoring for excessive sedation may be warranted in such cases.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Cold and Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate, 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. For adolescents aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours.

Caution is advised as excitability may occur, particularly in children, when used at nighttime. Additionally, marked drowsiness may also be experienced during nighttime use. It is essential to keep this medication out of reach of children.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients are included in the indication for this product, which is approved for use in adults and children aged 12 years and older. There is no specific geriatric use information provided in the prescribing information.

While the insert does not mention any specific dosage adjustments for elderly patients, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations for pharmacokinetics and pharmacodynamics in older adults.

Additionally, there are no outlined safety concerns or special precautions specifically for geriatric patients. However, as with any medication, it is advisable for healthcare providers to assess the overall health status and concurrent medications of elderly patients to ensure safe and effective use.

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 the safety of both the mother and the developing fetus.

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 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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to avoid taking this product in conjunction with other medications that also contain acetaminophen, as this can significantly increase the risk of liver injury. Additionally, patients should not exceed a total daily dose of 4,000 mg of acetaminophen, as doing so may lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily should exercise caution when using this product, as alcohol can exacerbate the risk of liver damage associated with acetaminophen.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in these individuals to prevent potential complications.

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 attention 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 interventions as necessary.

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, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other indications for medical consultation include worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period. 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, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to take DAYTIME and NIGHTTIME products concurrently, as this can lead to adverse effects. It is important to communicate the necessity of adhering to the recommended dosage and to avoid exceeding it.

For those using the NIGHTTIME product, healthcare providers should inform patients that excitability may occur, particularly in children, and that marked drowsiness is a common side effect. Patients should be cautioned against consuming alcoholic beverages while using the NIGHTTIME product, as this can exacerbate drowsiness. Additionally, they should be made aware of the risks associated with driving a motor vehicle or operating machinery after taking the NIGHTTIME product, as well as the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

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.

For optimal storage, the product must be kept at a temperature of 25°C (77°F). However, excursions are permitted within a range of 15° to 30°C (59° to 86°F). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding before use. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is vital for both adults and children, even in the absence of noticeable symptoms.

Additionally, parents are encouraged to educate themselves about the potential for teen medicine abuse by visiting www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

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.

View product document (PDF)