Cold Flu and Sore Throat Relief

Description

This formulation contains Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, and Phenylephrine HCl 10 mg. The product is designed for oral administration and is presented in a dosage form suitable for therapeutic use. It is packaged with a tamper-evident safety seal; do not use if the seal around or under the cap is broken or missing. The product is distributed by Better Living Brands LLC, located at P.O. Box 99, Pleasanton, CA 94566-0009. For additional information, visit the website at www.betterlivingbrandsLLC.com.

Uses and Indications

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

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 to ensure safety and efficacy. The maximum dosage should not exceed 6 doses within a 24-hour period.

Dosing should be measured exclusively with the dosing cup provided with the product; the use of any other dosing device is not recommended. It is advised to keep the dosing cup with the product at all times to facilitate accurate measurement.

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

Healthcare professionals should counsel patients to avoid exceeding the directed dosage and to be aware of the overdose warning associated with this medication.

Contraindications

Use of this product is contraindicated in the following situations:

Children under 12 years of age should not use this product due to safety concerns related to efficacy and potential adverse effects.

The product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications, as this may lead to serious drug interactions. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their current medications.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated to avoid the risk of acetaminophen overdose.

Additionally, the product should not be used in excess of the recommended dosage.

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, refrain from using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than three alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should be instructed 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 be advised to consult a healthcare provider promptly.

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

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should also be advised to stop taking the product and consult a healthcare professional if they experience any of the following: redness or swelling, nervousness, dizziness, sleeplessness, the emergence of new symptoms, worsening pain, nasal congestion, or cough lasting more than seven days, or if fever worsens or persists for more than three days. Additionally, if a cough recurs or occurs alongside a rash or headache that lasts, medical evaluation is warranted, as these may be signs of a serious condition.

Side Effects

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

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In the event of an overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent.

Patients should also be alert to the possibility of severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical assistance promptly.

In addition, patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional immediately.

Patients are advised to stop using the product and seek medical advice if they notice redness or swelling, experience nervousness, dizziness, or sleeplessness, or if new symptoms arise. Furthermore, if pain, nasal congestion, or cough worsens or lasts more than seven days, or if fever worsens or lasts more than three days, medical consultation is recommended. A return of cough, particularly if accompanied by a rash or headache that persists, may indicate a serious condition requiring attention.

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 or emotional conditions, or Parkinson's disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

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 use and to avoid potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Flu and Sore Throat Relief (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 every 4 hours as needed while symptoms persist. Safety and efficacy have not been established in children younger than 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. Due to the potential for overdose, which may lead to liver damage, it is crucial for patients to adhere strictly to the recommended dosage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. 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.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals should be vigilant in assessing the situation, as early intervention can be critical in managing potential complications associated with overdose.

Potential Symptoms

While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of monitoring patients closely and providing timely care.

In summary, any suspected overdose should be treated as a medical emergency, necessitating swift action to mitigate risks and ensure patient safety.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notable among these are severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the product be discontinued immediately and medical assistance sought.

Additionally, new symptoms may arise during treatment. Should any new symptoms present, it is advised to cease use and consult a healthcare professional, as these may indicate a serious condition.

In cases of overdose, prompt medical attention is essential. Individuals are advised to contact a Poison Control Center (1-800-222-1222) or seek medical help immediately, regardless of the presence of signs or symptoms, as timely intervention is critical for both adults and children.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

It is important to inform patients that this product is not intended for use in children under 12 years of age. Additionally, 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 drug within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Patients should also be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is any doubt regarding the presence of acetaminophen in other medications, patients should seek guidance from a healthcare professional.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience redness or swelling, nervousness, dizziness, or sleeplessness. Patients should also be advised to seek medical advice if new symptoms arise, or if pain, nasal congestion, or cough worsens or persists for more than 7 days. Furthermore, if fever worsens or lasts more than 3 days, or if a cough recurs or is accompanied by a rash or headache that lasts, patients should be instructed to contact their healthcare provider, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the directed dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: diabetes, liver disease, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), a cough accompanied by excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Additionally, patients taking the blood-thinning medication warfarin should be advised to seek guidance from their doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration. After opening, the product should be discarded to ensure safety and efficacy.

The container is designed with a tamper-evident feature; therefore, it should not be used if the printed safety seal around or under the cap is broken or missing.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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 Cold Flu and Sore Throat Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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