Robitussin Severe Multi-Symptom Cough Cold Flu

Description

Robitussin® MAXIMUM STRENGTH SEVERE Multi-Symptom Cough Cold + Flu is formulated for the relief of multiple symptoms associated with colds and flu. The active ingredients include acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. This product is indicated for the alleviation of cough, sore throat, body aches, fever, nasal congestion, and chest congestion. It is designed for use in individuals aged 12 years and older and is presented in a liquid dosage form, with a volume of 4 FL OZ (118 ml). The formulation is non-drowsy, providing powerful multi-symptom relief.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or flu, including cough due to minor throat and bronchial irritation, nasal congestion, sinus congestion and pressure, minor aches and pains, sore throat, and headache. Additionally, it temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating more productive coughs.

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

Dosage and Administration

Adults and children aged 12 years and over 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; 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) for depression, psychiatric, or emotional conditions, or Parkinson's disease, should not use this product. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

This product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is any doubt about the presence of acetaminophen in a medication, a healthcare professional should be consulted.

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, using it concurrently with other medications containing acetaminophen, or consuming 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 skin reaction occur, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

General Precautions This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in a prescription drug.

Prior to use, individuals should seek medical advice 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, a cough associated with excessive phlegm, or any breathing problems such as chronic cough, smoking-related issues, asthma, chronic bronchitis, or emphysema.

Additionally, consultation with a healthcare provider or pharmacist is recommended if the patient is taking the anticoagulant warfarin, any other oral nasal decongestant or stimulant, or any other pain reliever/fever reducer.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is essential. Timely medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation Patients should stop using this product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical 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 6 doses in any 24-hour period, which is the maximum daily amount, or if they use this product in conjunction with other medications containing acetaminophen. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may increase the risk of liver damage.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. 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 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are instructed 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 7 days; if fever worsens or lasts more than 3 days; if redness or swelling is present; if new symptoms arise; or if a cough returns or occurs with a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease.

Caution is advised when this medication is used in conjunction with anticoagulants such as warfarin. Patients should consult a healthcare professional prior to use if they are currently taking warfarin to assess potential interactions and necessary monitoring.

Additionally, patients are advised to seek guidance from a healthcare provider before using this medication alongside other oral nasal decongestants or stimulants, as well as other pain relievers or fever reducers. This precaution is essential to avoid possible additive effects or interactions that may compromise safety or efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Severe Multi-Symptom Cough Cold Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). 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. Children under this age should not use the product.

Geriatric Use

Elderly patients may require special consideration when using this product, which is not intended for individuals under 12 years of age. Prior to use, it is advisable for geriatric patients to consult a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties related to an enlarged prostate gland.

Additionally, elderly patients should seek guidance from a doctor or pharmacist if they are concurrently taking anticoagulants such as warfarin, or any other oral nasal decongestants or stimulants, to avoid potential drug interactions.

It is crucial for geriatric patients to adhere strictly to the recommended dosage and not exceed the directed amount. They should discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or insomnia, or if their pain, cough, or nasal congestion worsens or persists beyond 7 days. Furthermore, if fever increases or lasts more than 3 days, medical advice should be sought promptly.

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 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 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 condition.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 6 doses within any 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks associated with acetaminophen use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

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

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 question.

Postmarketing Experience

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

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, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical 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 stopped taking an MAOI within the last two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should consult with a doctor or pharmacist before using this product.

It is essential to instruct patients not to use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are unsure whether a drug contains acetaminophen, they should seek guidance from a doctor or pharmacist.

Patients should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop using the product and seek medical advice if pain, cough, or nasal congestion worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider.

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. When using this product, patients must adhere strictly to the recommended dosage and not exceed it.

Healthcare providers should encourage patients to consult a doctor before using this product 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. Patients with a cough that produces excessive phlegm or those with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this product if they are taking the blood-thinning medication warfarin, any other oral nasal decongestant or stimulant, or any other pain reliever or fever reducer.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

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 crucial 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 essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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