Tussin Severe

Description

H-E-B® Tussin SEVERE is a maximum strength formulation designed for the relief of multiple symptoms associated with cough, cold, and flu. This product contains the following active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. It is indicated for adults and individuals aged 12 and over, providing relief from cough, sore throat, fever, body aches, nasal congestion, and chest congestion. The formulation is non-drowsy and is presented in a raspberry flavor. Each bottle contains 4 FL OZ (118 mL) of the solution.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or flu. Specifically, it addresses the following symptoms: cough due to minor throat and bronchial irritation, nasal congestion, sinus congestion and pressure, minor aches and pains, sore throat, headache, and fever. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 5 doses are administered within a 24-hour period. Healthcare professionals should emphasize the importance of adhering to the recommended dosage, as exceeding this may result in serious liver damage.

The dosing cup provided with the product must be used for accurate measurement; it is essential to keep the dosing cup with the product at all times to ensure proper dosing. This product is not intended for use in children under 12 years of age.

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.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

This product should not be used by individuals with a known history of allergic reactions to it or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly 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.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must 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 physician without delay.

Healthcare professionals should exercise caution and recommend that patients consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, patients with persistent or chronic coughs, such as those resulting from smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product. It is essential to advise patients to consult a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin.

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 right away, regardless of whether symptoms are present.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical consultation is warranted. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting beyond a short duration may indicate a serious condition, necessitating prompt medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

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

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling is observed; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Prior to use, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should seek medical advice. Additionally, those experiencing a cough with excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare provider.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients should exercise caution when using this medication in conjunction with certain other drugs due to potential interactions.

Anticoagulants

• The concurrent use of this medication with warfarin, a blood-thinning agent, should be approached with caution. Patients are advised to consult a healthcare professional prior to use to assess the risk of increased bleeding.

Monoamine Oxidase Inhibitors (MAOIs)

• This medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are typically prescribed for depression, psychiatric conditions, or Parkinson’s disease. The combination may lead to serious adverse effects.

Acetaminophen-containing Products

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is not recommended. Patients should verify the contents of any additional medications with a healthcare provider or pharmacist to avoid exceeding the recommended dosage of acetaminophen, which could lead to hepatotoxicity.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Severe (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). 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 every 4 hours, with a maximum of 5 doses in any 24-hour period.

Healthcare professionals should be aware of the importance of monitoring for overdose, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on this medication.

Overdosage

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. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that medical personnel monitor the patient closely and provide supportive care as needed.

In cases of suspected overdose, the following steps should be taken:

1. Assessment: Evaluate the patient's condition, including vital signs and level of consciousness.

2. Supportive Care: Administer appropriate supportive measures based on the patient's clinical presentation.

3. Poison Control Consultation: Engage with a Poison Control Center for guidance on specific management protocols and antidotes, if applicable.

Timely and effective management can significantly influence the outcome in overdose 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 assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. These events have been documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one 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.

It is important to instruct patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. Patients should be advised to verify the presence of acetaminophen in their medications by consulting a healthcare professional if they are unsure.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, they should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Healthcare providers should also inform patients to stop using the product and seek medical advice if their pain, cough, or nasal congestion worsens or persists for more than seven days. Similarly, if a fever worsens or lasts more than three days, or if any redness or swelling occurs, patients should be advised to contact their healthcare provider. New symptoms that arise during treatment should also prompt a consultation with a doctor.

Patients should be cautioned to stop use and seek medical attention if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition. It is essential to remind patients to adhere strictly to the recommended dosage and not exceed the directed amount.

Before using this product, patients should be encouraged to consult their doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, patients with a cough that produces excessive phlegm or a persistent or chronic cough, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult their doctor or pharmacist before using this product.

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 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. Patients should not exceed 5 doses within a 24-hour period and must adhere to the recommended dosage to avoid potential risks.

Clinicians should counsel patients to keep the medication out of reach of children and to be aware of overdose risks. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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