Severe Cold and Cough Relief

Description

This formulation is designed for individuals aged 12 years and older and is indicated for the relief of severe cold and cough symptoms during the daytime. The active ingredients include acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and phenylephrine HCl, acting as a nasal decongestant. The product contains 10% alcohol and is available in a liquid dosage form with a berry flavor. It is packaged in a tamper-evident container, and users are advised not to use the product if the printed safety seal around or under the cap is broken or missing. This product is distributed by Old East Main Co., located at 100 Mission Ridge, Goodlettsville, TN 37072, and is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including minor aches and pains, headache, nasal and sinus congestion, sore throat, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

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 to avoid the risk of overdose. The maximum allowable dosage is 6 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours as needed. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times for convenience and safety.

For children under 12 years of age, the product is not recommended and should not be used.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose.

Additionally, exceeding the recommended dosage while using this product is contraindicated, as it may lead to adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger 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.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before use.

In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond seven days; if fever intensifies or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs alongside a rash or headache that persists. 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. In cases of 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 associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients must discontinue use and seek medical assistance promptly.

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

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

Before using this product, patients should consult a healthcare provider if they have a history of liver disease, heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating therapy if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety and therapeutic efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Cold and Cough Relief (acetaminohpen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should not use this medication. For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. 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 contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 on the excretion of this drug 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 to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a dosage of 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 imperative that patients with liver disease consult a healthcare professional prior to using this product. In the event of an overdose, which may result from taking more than the recommended dose, patients must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Monitoring of liver function may be warranted in patients with compromised liver function to mitigate the risk of potential hepatotoxicity.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for guidance. This step is vital regardless of whether any symptoms are present, as both adults and children are at risk.

Potential Symptoms While specific symptoms of overdose may not always be immediately apparent, the potential for liver damage underscores the importance of prompt evaluation and treatment.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as necessary. Early intervention can significantly impact outcomes, making it essential to act swiftly in these situations.

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 the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, as exceeding this dosage may lead to liver damage. In the event of an overdose, patients must seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop use and seek medical advice if pain, cough, or nasal congestion worsens or persists beyond 7 days, if fever intensifies or lasts more than 3 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 is accompanied by a rash or a persistent headache, they should seek medical attention, as these may indicate a serious condition.

It is essential for patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to seek medical guidance if they have a cough that produces excessive phlegm or if they suffer from a persistent or chronic cough associated with smoking, asthma, or emphysema.

Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist prior to use.

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 a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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