Cold, Flu and Sore Throat

Description

QUALITY +PLUS is a liquid formulation containing the following active ingredients: acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl. This product serves multiple therapeutic purposes, including pain relief, fever reduction, cough suppression, expectoration, and nasal decongestion.

The formulation is presented in a mixed berry flavor and is packaged in a volume of 6 fluid ounces (177 mL). It is important to note that the product features a tamper-evident safety seal; it should not be used if the seal under the cap is broken or missing.

QUALITY +PLUS is distributed by LNK INTERNATIONAL, INC., located at 60 Arkay Drive, Hauppauge, NY 11788, USA. The National Drug Code (NDC) for this product is 50844-005-45.

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, cough due to minor throat and bronchial irritation, headache, nasal congestion, and sore throat. Additionally, it temporarily promotes nasal and/or sinus drainage, reduces fever, and aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby 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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. The maximum dosage should not exceed the directed amount, and patients must not take more than six doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered using the dosing cup provided, every 4 hours as needed. It is imperative that the dosing cup included with the product is utilized to ensure accurate measurement.

Children under 12 years of age should not use this medication.

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

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury may occur if they 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 taking this product.

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

Healthcare providers should also caution patients regarding sore throat symptoms. If a sore throat is severe, 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.

It is imperative that patients do not exceed the recommended dosage of this product.

In cases of accidental overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain, nasal congestion, or cough lasting more than seven days; the emergence of new symptoms; feelings of nervousness, dizziness, or sleeplessness; fever worsening or persisting beyond three days; presence of 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 underlying condition that requires 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 blisters, rash, or skin reddening. If any of these symptoms occur, 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 also advised to stop use and contact a doctor if they experience worsening pain, nasal congestion, or cough lasting more than seven days, new symptoms arise, or if they encounter 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 attention.

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

Patients taking the blood-thinning medication warfarin should also seek advice from a doctor or pharmacist prior to use.

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), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI to avoid potential hypertensive crises.

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 warranted to ensure safe and effective use.

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 20 mL administered every 4 hours using the dosing cup provided. It is essential to keep this medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. 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, as liver function may influence renal clearance and overall drug metabolism. 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 a maximum dosage of 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 with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to remain vigilant, as the presentation of symptoms may vary. Early intervention can significantly impact the outcome of an overdose situation. Therefore, it is essential to ensure that patients and caregivers are aware of the importance of timely medical evaluation following any suspected overdose incident.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, including blisters, rash, and skin reddening. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

It is important to inform patients that they should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a healthcare professional.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If patients are unsure whether their prescription includes an MAOI, they should seek clarification from their healthcare provider.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised not to use it. They should also be instructed to discontinue use and consult a doctor if their pain, nasal congestion, or cough worsens or persists for more than seven days. Additionally, they should seek medical advice if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness.

If patients notice that their fever worsens or lasts longer than three days, or if they observe any redness or swelling, they should stop using the product and contact a healthcare professional. Patients should also be informed to seek medical attention if their cough returns or occurs alongside a rash or headache that persists, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage. They should be encouraged to consult a doctor before use if they have a cough accompanied by excessive phlegm, liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, diabetes, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a healthcare professional before using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients should be informed 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. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use.

Additionally, parents are encouraged to educate themselves about the potential for medicine abuse among teenagers by visiting www.StopMedicineAbuse.org. No further information is 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.

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