Walgreen Severe Multi-Symptom Cough Cold Flu

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 or influenza. Specifically, it addresses the following symptoms: cough due to minor throat and bronchial irritation, nasal congestion, sinus congestion and pressure, minor aches and pains, sore throat, headache, and fever. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 20 milliliters (ml) administered every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, as exceeding this may result in serious liver damage.

The dosing cup provided with the product must be used for accurate measurement; it is essential to keep the dosing cup with the product at all times to ensure proper dosing. This product is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, should not use this product. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

This product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is any doubt about the presence of acetaminophen in a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 doses within a 24-hour period, using it concurrently with other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to 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 immediately and seek medical assistance.

Consultation Required for Severe Symptoms If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

General Precautions This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a doctor or pharmacist is advised.

Healthcare professionals should recommend that patients seek medical advice 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 an enlarged prostate gland, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema.

Additionally, patients should consult a doctor or pharmacist before using this product if they are taking the anticoagulant warfarin, any other oral nasal decongestant or stimulant, or any other pain reliever/fever reducer.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Medical Consultation Patients should stop using this product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond 7 days; if fever worsens or lasts more than 3 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 condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting for an extended period may indicate a serious condition, warranting prompt medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with 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 Walgreen Severe Multi-Symptom Cough Cold Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For patients aged 12 years and older, the recommended dosage is 20 ml every 4 hours. Caution is advised when considering the use of this product in younger populations, as safety and efficacy have not been established in children under 12 years.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific guidelines are not outlined.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 6 doses within any 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to using this product to assess the potential risks and determine appropriate usage. Monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data does not provide any details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with the use of acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

It is important to inform patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should be advised to verify the contents of their medications with a healthcare professional if they are unsure.

Patients should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, cough, or nasal congestion worsens or persists beyond seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider.

Patients should be made aware that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. While using this product, patients must adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with chronic respiratory issues, such as asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin, any other oral nasal decongestants or stimulants, or any other pain relievers or fever reducers 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 room temperature, ensuring that it is not exposed to refrigeration. Proper storage conditions are crucial to maintain the integrity and efficacy 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. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)