Robitussin Maximum Strength Severe Cough Plus Sore Throat

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, minor aches and pains, sore throat pain, and headache. Additionally, it temporarily reduces fever.

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 6 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, and it should be kept 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) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing an MAOI. 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 also 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.

Additionally, it is important to adhere to the recommended dosage and not exceed the directed use of this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 doses within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Consultation Prior to Use Healthcare professionals should advise patients to consult a doctor before using this product if they have liver disease, a cough associated with excessive phlegm (mucus), or any breathing problems, including chronic coughs related to smoking, asthma, or emphysema. Additionally, patients should be instructed to seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin or any other pain reliever or fever reducer.

Emergency Medical Assistance In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation of Use Patients should be advised to stop using this product and consult a doctor if any of the following occur: pain or cough worsens or persists beyond 7 days; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur if patients exceed six doses within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases when this product is taken in conjunction with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily.

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

This product is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the cessation of such medication. Patients uncertain about whether their prescription includes an MAOI should consult a healthcare professional prior to use. Furthermore, this product should not be used in combination with any other drug containing acetaminophen, whether prescription or nonprescription.

Patients are advised to stop use and consult a doctor if pain or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of potential overdose and severe liver damage.

Additionally, caution is advised when using this medication in conjunction with warfarin, a blood-thinning agent. The combination may elevate the risk of bleeding. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment if they are currently taking warfarin. Monitoring for signs of increased bleeding may be warranted in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Maximum Strength Severe Cough Plus Sore Throat (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours. Caution is advised when considering the use of this product in younger populations, as safety and efficacy have not been established in children under 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 potential 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 or nursing 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 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 not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 6 doses in any 24-hour period, which is the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing 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 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

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 attention is critical for both adults and children, regardless of whether any signs or symptoms are initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate interventions as necessary.

Management of an overdose may involve supportive care and symptomatic treatment, tailored to the specific circumstances and clinical presentation of the patient. Continuous assessment and vigilance are crucial in ensuring optimal outcomes in cases of suspected overdose.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days. Additionally, they should seek medical advice if a fever intensifies or lasts longer than 3 days, or if they notice any redness or swelling. New symptoms that arise during treatment should also prompt a discussion with a healthcare provider. Patients should be particularly vigilant if a cough returns or occurs alongside a rash or headache that persists, as these may indicate a serious condition.

While using this product, patients must adhere strictly to the recommended dosage and not exceed the directed amount. It is important for patients to consult a doctor before use if they have liver disease, a cough accompanied by excessive phlegm (mucus), or any breathing problems, including chronic coughs related to smoking, asthma, or emphysema.

Furthermore, patients should be encouraged to speak with their doctor or pharmacist prior to using this product if they are currently taking the blood-thinning medication warfarin or any other pain reliever or fever reducer, to avoid potential interactions.

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 handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Robitussin Maximum Strength Severe Cough Plus Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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