Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime

Description

Robitussin® Maximum Strength Severe Multi-Symptom 7 in 1 Relief is formulated for individuals aged 12 and over. Each dosage unit contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and doxylamine succinate, an antihistamine. The product is presented in the form of 10 liquid-filled capsules, designed to provide comprehensive relief from multiple symptoms associated with cold and flu.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with colds, flu, hay fever, and other upper respiratory allergies. The symptoms alleviated by this medication include headache, sore throat, cough, minor aches and pains, runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat. Additionally, this drug 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 2 capsules every 6 hours as needed. It is imperative that the total dosage does not exceed 8 capsules 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.

This product is not intended for use in children under 12 years of age. Therefore, it is crucial to avoid administration in this population to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

• It should not be used to sedate a child or induce sleepiness in pediatric patients.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease, and extends for 2 weeks after discontinuation of the MAOI. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their prescription.

• The product must not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. Patients should verify the contents of their medications with a healthcare provider if unsure.

Additionally, while using this product, patients should avoid alcoholic beverages, as alcohol may enhance drowsiness when combined with this medication.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 capsules within a 24-hour period, using 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.

Consultation Prior to Use Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be instructed to seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin, any other pain reliever or fever reducer, or sedatives and tranquilizers.

Severe Symptoms and Emergency Situations Patients should be informed to seek immediate medical help or contact a Poison Control Center in the event of an overdose. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation of Use Patients are advised to stop taking this product and consult a doctor if any of the following occur: worsening pain or cough lasting more than 7 days, fever worsening or persisting for more than 3 days, presence of redness or swelling, recurrence of cough accompanied by rash or headache lasting, or the emergence of new symptoms. These may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 8 capsules within a 24-hour period, use this product in conjunction with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause 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 and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

While using this product, marked drowsiness may occur, and patients are cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Care should be taken when driving a motor vehicle or operating machinery. Additionally, excitability may be observed, particularly in children.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition. New symptoms should also prompt a consultation with a healthcare provider.

Before using this product, patients should seek medical advice if they have liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, or a chronic breathing problem or cough related to smoking, asthma, chronic bronchitis, or emphysema. It is also recommended to consult a doctor or pharmacist if the patient is taking the blood-thinning medication warfarin, any other pain reliever or fever reducer, or sedatives or tranquilizers.

This product should not be used to sedate a child or induce sleepiness in a child. It is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. Patients should verify with a healthcare professional if they are uncertain whether their prescription contains an MAOI. Furthermore, this product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription.

Drug Interactions

Concurrent use of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this product, as there may be an increased risk of bleeding due to potential pharmacodynamic interactions.

It is advisable for individuals using any other pain relievers or fever reducers to seek guidance from a healthcare provider or pharmacist before initiating this product, to avoid additive effects and potential toxicity.

Patients currently on sedatives or tranquilizers should also consult with a healthcare professional prior to use, as there may be an increased risk of central nervous system depression.

This product is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks, due to the risk of serious and potentially life-threatening interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime (acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate). 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. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

Elderly patients may experience increased sensitivity to this product, particularly regarding drowsiness. It is advised that geriatric patients exercise caution when using this product, especially in conjunction with alcohol, sedatives, or tranquilizers, as these substances may exacerbate drowsiness. Consequently, elderly patients should be vigilant when driving or operating machinery.

Patients aged 65 and older should consult a healthcare provider prior to use, particularly if they have a history of liver disease, as this may necessitate dosage adjustments or increased monitoring for adverse effects.

In the event that symptoms such as pain or cough worsen or persist beyond 7 days, or if fever worsens or lasts more than 3 days, it is imperative for elderly patients to discontinue use and seek medical advice. Additionally, the presence of redness, swelling, or a cough that recurs with a rash or headache warrants immediate consultation with a healthcare professional, as these may indicate a serious underlying condition.

Elderly patients who are pregnant or breastfeeding should also seek guidance from a healthcare professional before using this product. It is crucial to keep this product out of reach of children, and in cases of overdose, prompt medical attention should be sought, as timely intervention is essential for both adults and children, regardless of the presence of symptoms.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 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.

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 dosage of 8 capsules within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with liver disease are advised to consult a healthcare professional prior to using this product. It is also recommended that patients refrain from consuming alcoholic beverages while using this product, as the intake of 3 or more alcoholic drinks daily may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function 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 intervention 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 medical care as needed.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data do not provide any details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified adverse reactions associated with the use of acetaminophen. Reports include severe skin reactions, which encompass skin reddening, blisters, and rash. These events have been documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial 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 apparent.

Patients should be informed that this product is not intended for use in sedating children or inducing sleepiness. Additionally, it should not be used if the patient is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking an MAOI drug within the last two weeks. If patients are uncertain whether their prescription contains an MAOI, they should consult with a doctor or pharmacist before using this product.

It is important to instruct patients not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should be encouraged to ask a healthcare professional if they are unsure whether a drug contains acetaminophen.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also seek medical advice if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition. Furthermore, patients should stop use and consult a doctor if new symptoms arise.

When using this product, patients may experience marked drowsiness and should be cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should exercise caution when driving or operating machinery.

Healthcare providers should inform patients that excitability may occur, particularly in children. Patients with liver disease, glaucoma, difficulty urinating due to an enlarged prostate gland, a cough accompanied by excessive phlegm, or chronic respiratory issues such as asthma, chronic bronchitis, or emphysema should consult a doctor before using this product. Additionally, patients taking the blood-thinning medication warfarin or any other pain reliever/fever reducer, as well as those on sedatives or tranquilizers, should seek advice from 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 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

This file contains official product information for Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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