Severe Cold and Flu

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 minor aches and pains, headache, sore throat, cough, nasal congestion, sinus congestion and pressure, sneezing, and runny nose (for nighttime use only). It also aids in loosening phlegm (mucus) and thinning bronchial secretions to enhance the productivity of coughs during the daytime. Additionally, this drug helps to clear nasal passages, relieves cough to facilitate sleep, and 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 for appropriate dosing guidance.

Contraindications

The concurrent use of DAYTIME and NIGHTTIME products is contraindicated. Additionally, this product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Use is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI prior to using this product.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic drinks daily while taking this product.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. Should any of these reactions occur, patients must 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 instructed to consult a physician without delay.

General precautions are essential for safe use. Patients should be advised to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate enlargement, a cough associated with excessive phlegm, or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, those with nighttime breathing problems or glaucoma should seek medical advice before use.

Patients taking anticoagulants such as warfarin or sedatives and tranquilizers should also consult a healthcare professional or pharmacist before using this product.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek emergency medical help right away, regardless of whether symptoms are present.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than seven days, fever lasting more than three days, redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache should prompt immediate medical evaluation, as these may indicate a serious condition.

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. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should be vigilant for symptoms that warrant discontinuation of the product and consultation with a healthcare provider. These symptoms include nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache, as these may indicate a serious underlying condition.

During use, patients may experience excitability, particularly in children, as well as marked drowsiness, especially at nighttime. The concomitant use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages during this time. Caution is recommended when driving or operating machinery due to the potential for increased drowsiness.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement should consult a healthcare provider prior to use. Additionally, those with persistent or chronic coughs, breathing problems like emphysema or chronic bronchitis, or glaucoma should seek medical advice. It is also important for patients taking blood thinners, such as warfarin, or those on sedatives or tranquilizers to consult with a healthcare professional before using this product.

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 warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Cold and Flu (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 this population, excitability may occur, particularly during nighttime administration. Additionally, marked drowsiness is a potential side effect when used at night.

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. Caution is advised when administering this medication to younger children due to the potential for adverse effects.

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, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties related to prostate enlargement. Additionally, those with chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema, as well as glaucoma, should seek medical advice before initiating treatment.

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

When using this product, it is critical for geriatric patients to adhere strictly to the recommended dosage, as exceeding this may lead to increased excitability, particularly in younger populations, and marked drowsiness may be experienced. The consumption of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, and therefore, it is recommended that elderly patients avoid alcoholic beverages while using this product. Caution is advised when driving or operating machinery, especially during nighttime use.

Elderly patients should discontinue use and seek medical attention if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms such as pain, nasal congestion, or cough worsen or persist beyond 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Signs of serious conditions may include the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache lasting longer than expected.

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 no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended for lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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 concomitant 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

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section or regarding animal pharmacology and toxicology.

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 immediately and seek medical assistance.

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 crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

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

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 important safety measures, including the necessity of consulting a health professional if pregnant or breastfeeding. 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, regardless of the presence of symptoms.

Additionally, clinicians should be aware of the potential for medicine abuse among teens and can refer to www.StopMedicineAbuse.org for further information.

Drug Information (PDF)

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

View product document (PDF)