Cold, Flu and Sore Throat

Description

NDC 0363-8005-45. This product is a maximum strength formulation intended for the relief of symptoms associated with cold, flu, and sore throat. It contains acetaminophen as a pain reliever and fever reducer, dextromethorphan HBr as a cough suppressant, guaifenesin as an expectorant, and phenylephrine HCl as a nasal decongestant. The dosage form is a liquid, with a volume of 6 FL OZ (177 mL). The product is distributed by Walgreen Co., Deerfield, IL 60015. It features a tamper-evident seal; do not use if the safety seal under the cap is broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, sinus congestion and pressure, stuffy nose, nasal congestion, sore throat, cough, and headache. Additionally, it temporarily promotes nasal and/or sinus drainage and reduces fever. The formulation aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum allowable dosage is 6 doses within a 24-hour period. It is imperative that only the dose cup provided with the medication is utilized for accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. For children under 12 years of age, the use of this medication is not recommended.

Healthcare professionals should ensure that patients understand the importance of not exceeding the directed dosage to avoid potential adverse effects.

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), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, is contraindicated. Additionally, use is prohibited for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor the total daily intake of acetaminophen to prevent potential hepatotoxicity.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as rash, blisters, or skin reddening. Should any of these symptoms occur, the patient must discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential for the patient to consult a physician promptly to rule out serious underlying conditions.

General Precautions Patients should be advised not to exceed the recommended dosage of this product.

Emergency Medical Help 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, regardless of the presence of symptoms, as prompt intervention is vital for both adults and children.

Stop Taking and Call Your Doctor Patients should discontinue use and consult a healthcare provider if they experience any of the following: worsening pain, nasal congestion, or cough lasting more than seven days; the emergence of new symptoms; nervousness, dizziness, or sleeplessness; fever worsening or persisting beyond three days; redness or swelling; or a cough that 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

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 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 rash, blisters, or skin reddening. If any skin reaction occurs, patients are advised 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 consult a healthcare professional promptly.

Patients are instructed to stop use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than seven days, if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness. Furthermore, if fever worsens or lasts more than three days, or if redness or swelling is present, medical advice should be sought. A return of cough or occurrence of cough with rash or headache that lasts may indicate a serious condition requiring medical evaluation.

Before using this product, patients should consult a doctor if they have a cough accompanied by excessive phlegm, liver disease, heart disease, diabetes, difficulty urinating due to prostate enlargement, high blood pressure, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with thyroid disease should also seek medical advice prior to use.

Lastly, it is recommended that patients taking the blood-thinning medication warfarin consult a doctor or pharmacist before using this product.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in anticoagulant effect.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided.

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 a Poison Control Center should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before initiating treatment. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function 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, as this may further increase the risk of liver injury.

Patients who consume three or more alcoholic drinks daily should refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

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 observable 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 relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other aspects of nonclinical toxicology. Additionally, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details have been reported in the available data.

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 exceed the recommended dosage of the medication. It is important for healthcare providers to encourage patients to consult with a doctor prior to use if they have any of the following conditions: a cough that produces excessive phlegm (mucus), liver disease, heart disease, diabetes, difficulty urinating due to prostate gland enlargement, high blood pressure, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with thyroid disease should also be advised to seek medical guidance before using the medication.

Furthermore, healthcare providers should recommend that patients consult with a doctor or pharmacist before using this medication if they are currently taking the blood-thinning medication warfarin, to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No additional information is available regarding laboratory tests or postmarketing experience.

Clinicians should be aware that the medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Patients who are pregnant or breastfeeding are advised to consult a healthcare professional prior to use. Additionally, resources on teen medicine abuse can be found at www.StopMedicineAbuse.org.

Drug Information (PDF)

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

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