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 symptoms associated with the common cold and influenza. Specifically, it alleviates sinus congestion and pressure, nasal congestion, minor aches and pains, headache, runny nose, sneezing, sore throat, fever, and cough due to minor throat and bronchial irritation. Additionally, it aids in promoting sleep by addressing cough and reduces swelling of the nasal passages, thereby facilitating nasal and/or sinus drainage and restoring freer breathing through the nose.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum limit of 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should remind patients of the importance of not exceeding the recommended dosage to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it 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 must be emphasized, particularly regarding the risk of overdose. In the event of an overdose, immediate medical attention is critical. Patients should be directed to contact a Poison Control Center at 1-800-222-1222, regardless of whether they exhibit signs or symptoms of overdose.

Patients should also be instructed to seek emergency medical help if they experience any of the following: increased 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; the emergence of new symptoms; or a cough that recurs or occurs alongside a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition that requires immediate evaluation.

Side Effects

Severe adverse reactions associated with the use of acetaminophen include the potential for severe liver damage, particularly when exceeding 4,000 mg within a 24-hour period, using other medications containing acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product.

Patients may also experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should be advised to consult a healthcare provider if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare professional include nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or lasts more than three days; presence of redness or swelling; occurrence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or those experiencing a cough with excessive phlegm, breathing problems (e.g., emphysema or chronic bronchitis), or urinary difficulties due to an enlarged prostate gland should seek medical advice prior to use. Additionally, individuals with a persistent or chronic cough related to smoking, asthma, or emphysema, as well as those on a sodium-restricted diet, should consult a healthcare provider before using this product.

It is also recommended that patients consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as these may interact with acetaminophen.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 12 years, it is advised to consult a healthcare professional before use.

For adolescents and adults aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. In the event of an overdose, prompt medical attention is essential for both children and adults, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 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 available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of liver damage increases if patients take other medications containing acetaminophen or consume three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of hepatotoxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid concurrent use of other acetaminophen-containing products and excessive alcohol consumption. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with excessive intake of acetaminophen. Specifically, the risk of significant hepatic injury increases when the total daily dosage exceeds 4,000 mg. Healthcare professionals should be vigilant in monitoring patients who may have ingested amounts above this threshold.

Should a patient exhibit any signs of a skin reaction, it is imperative to stop the use of the medication immediately and seek medical assistance without delay. Such reactions may signify an overdose or a severe allergic response, necessitating prompt evaluation and intervention.

Management of acetaminophen overdosage typically involves supportive care and may require specific antidotal treatment, depending on the severity of the situation. Healthcare providers should ensure that patients receive appropriate medical attention to mitigate the risks associated with overdosage and to monitor for any complications that may arise.

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 potential for severe skin reactions associated with acetaminophen use. Reports indicate that symptoms 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 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 at 1-800-222-1222 in the event of an overdose, emphasizing the importance of prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage, as taking more than directed can lead to serious health risks. It is important to inform patients that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect.

Providers should counsel patients to avoid consuming alcoholic beverages while using this medication, as alcohol can exacerbate drowsiness. Additionally, patients should be cautioned about the potential for increased drowsiness when combined with sedatives or tranquilizers.

Finally, healthcare providers should remind patients to exercise caution when driving or operating machinery, as the medication may impair their ability to perform these tasks safely.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)