Cold, Flu and Sore Throat

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 headache, cough, nasal congestion, sore throat, and minor aches and pains. It also temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the maximum daily limit. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 12 caplets within a 24-hour period.

It is important to note that this medication is not indicated for use in children under 12 years of age. Healthcare professionals should ensure that patients understand the importance of following these guidelines to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

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 essential to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as blisters, rash, or skin reddening. Should any skin reaction occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, diabetes, thyroid disease, a cough associated with excessive phlegm, difficulty urinating due to prostate enlargement, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), heart disease, or high blood pressure. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist prior to use.

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 whether symptoms are present.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if they experience new symptoms, redness or swelling, nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days. A return of cough accompanied by a rash or headache that lasts may indicate a serious condition requiring further evaluation.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while using this product.

Patients should be aware of the potential for severe skin reactions, which may manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if patients experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

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

Before using this product, patients with pre-existing conditions such as liver disease, diabetes, thyroid disease, or heart disease should consult a healthcare provider. This also applies to those experiencing a cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use, as interactions may occur.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects. Adjustments to the dosage of either drug may be required based on clinical judgment and patient response.

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 adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum dosage not exceeding 12 caplets in a 24-hour period. In the event of an overdose, it is crucial to seek prompt medical attention for both adults and children, 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 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.

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, as this may further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients 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 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

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. They should also be informed to discontinue use and consult a doctor if they experience new symptoms, or if they notice any redness or swelling. Additionally, patients should be made aware that they should stop using the medication and seek medical advice if they experience nervousness, dizziness, or sleeplessness.

It is important for patients to be vigilant regarding their symptoms. They should stop use and consult a healthcare professional if pain, nasal congestion, or cough worsens or persists for more than 7 days. Similarly, if fever worsens or lasts more than 3 days, patients should seek medical advice. Patients should also be cautioned to stop use and consult a doctor if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

Before initiating treatment, patients should be encouraged to consult a healthcare provider if they have any of the following conditions: liver disease, diabetes, thyroid disease, a cough accompanied by excessive phlegm, difficulty urinating due to prostate enlargement, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), heart disease, or high blood pressure. Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to use.

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. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-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. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 12 caplets in a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

Additionally, information regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org. No further details are available regarding laboratory tests or postmarketing experiences.

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.

View product document (PDF)