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Robitussin Honey Severe Cough, Flu Plus Sore Throat

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Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
May 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
May 13, 2025
Manufacturer
Haleon US Holdings LLC
Registration number
M012
NDC root
0031-8771
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Robitussin Honey is a medication designed to help relieve symptoms associated with colds and the flu, specifically for adults and children aged 12 and older. It contains acetaminophen (a pain reliever and fever reducer) and dextromethorphan HBr (a cough suppressant), making it effective for temporarily alleviating cough due to throat and bronchial irritation, minor aches and pains, sore throat pain, and headaches. Additionally, it helps to reduce fever and soothe sore throat discomfort.

This maximum strength formula is non-drowsy and is flavored with real honey and elderberry, providing a pleasant taste while addressing your symptoms. With an 8 FL OZ (237 mL) volume, Robitussin Honey aims to support your recovery during cold and flu season.

Uses

This medication is designed to help you feel better when you're dealing with the discomforts of a cold or flu. It can temporarily relieve symptoms such as a cough caused by minor irritation in your throat and bronchial tubes, as well as minor aches and pains, sore throat pain, and headaches. Additionally, it can help reduce fever, making you more comfortable as you recover.

You can rely on this medication to ease these common symptoms, allowing you to rest and heal more effectively.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage carefully to ensure your safety. For adults and children aged 12 years and older, you should take 20 milliliters (mL) every 4 hours. However, make sure not to take more than 6 doses within a 24-hour period. Taking more than the recommended amount can lead to serious liver damage, so always stick to the dosage guidelines.

To measure your dose accurately, use the dosing cup that comes with the product, and keep it with the medication for easy access. Remember, this product is not suitable for children under 12 years of age, so please do not use it for younger individuals.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease. Additionally, do not take this product for at least two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's also important not to use this product alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you have any doubts about whether a drug contains acetaminophen, ask your healthcare provider. Lastly, always follow the dosing instructions carefully and do not exceed the recommended amount.

Side Effects

You should be aware that taking more than 6 doses of this medication in a 24-hour period, using it with other products containing acetaminophen, or consuming 3 or more alcoholic drinks daily can lead to severe liver damage. Additionally, acetaminophen may cause serious skin reactions, which can include symptoms like skin reddening, blisters, or rash. If you experience any of these skin reactions, stop using the product and seek medical help immediately.

If you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. You should also stop using the medication and contact a healthcare professional if your pain or cough worsens or lasts more than 7 days, if your fever persists for more than 3 days, or if you notice any new symptoms. It's important to talk to your doctor before using this product if you have liver disease, a chronic cough, or if you are taking blood thinners like warfarin.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 6 doses in a 24-hour period, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any skin reactions, stop using the product and seek medical help immediately. Additionally, if you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, do not take it if you are currently on a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the past 2 weeks. Avoid using it with any other medications that contain acetaminophen. If you have liver disease, a cough with excessive mucus, or breathing issues, consult your doctor before use. It's also important to ask your doctor or pharmacist if you are taking blood thinners like warfarin or any other pain relievers.

In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, as prompt attention is crucial. Stop using the product and call your doctor if your pain or cough worsens or lasts more than 7 days, if your fever worsens or lasts more than 3 days, if you notice redness or swelling, or if new symptoms develop. These could indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Remember, acting quickly can make a significant difference, so don’t hesitate to get help. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

This product is specifically designed for adults and should not be used in children under 12 years of age. If your child is younger than 12, it is important to avoid using this medication altogether. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

This medication is designed for adults and is not suitable for children under 12 years old. If you are an older adult or caring for one, it's important to ensure that this product is used appropriately, as it may not be safe or effective for younger individuals. Always consult with a healthcare professional if you have any questions about its use or if you need guidance on dosage and safety.

Renal Impairment

If you have kidney issues, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney problems). This means that there are no tailored recommendations for how your kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not exceed 6 doses in a 24-hour period, and be careful not to take other medications that also contain acetaminophen. Additionally, limit your alcohol intake to fewer than 3 drinks per day while using this product, as drinking more can increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to be cautious when using this medication, especially if you are taking other drugs. You should not use it alongside a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or Parkinson's disease, or for two weeks after stopping an MAOI. Additionally, avoid using this medication with any other products that contain acetaminophen, as this can lead to serious health issues.

If you are taking blood thinners like warfarin, be aware that this combination may increase your risk of bleeding. Always consult with your doctor or pharmacist before using this medication, especially if you are taking any other pain relievers or fever reducers. Discussing your medications and any lab tests with your healthcare provider is crucial to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25°C (68-77°F). It's important not to refrigerate the product, as this can affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe and effective use.

Additional Information

You should take this medication orally, with adults and children aged 12 years and older typically taking 20 mL every 4 hours. If you have children under 12, do not use this medication for them. If you are pregnant or breastfeeding, consult a healthcare professional before using it. Always keep the medication out of reach of children.

In case of an overdose, it’s important to seek medical help immediately or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if there are no noticeable symptoms. For information on the potential misuse of medications, especially among teens, you can visit www.StopMedicineAbuse.org.

FAQ

What is Robitussin Honey used for?

Robitussin Honey is used to temporarily relieve symptoms of severe cough, flu, and sore throat in adults and children aged 12 and over.

What are the active ingredients in Robitussin Honey?

It contains Acetaminophen, a pain reliever and fever reducer, and Dextromethorphan HBr, a cough suppressant.

What is the recommended dosage for adults and children over 12?

The recommended dosage is 20 mL every 4 hours, not to exceed 6 doses in a 24-hour period.

Are there any contraindications for using Robitussin Honey?

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) or any other drug containing acetaminophen.

What should I do if I experience severe skin reactions?

If you notice symptoms like skin reddening, blisters, or rash, stop using the product and seek medical help immediately.

What are the potential liver risks associated with Robitussin Honey?

Severe liver damage may occur if you take more than 6 doses in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

Can I use Robitussin Honey if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Robitussin Honey.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

How should I store Robitussin Honey?

Store Robitussin Honey at 20-25°C (68-77°F) and do not refrigerate.

Packaging Info

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

Packaging configurations for Robitussin Honey Severe Cough, Flu Plus Sore Throat.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Robitussin Honey is a maximum strength formulation designed for adults experiencing severe cough, flu, and sore throat symptoms. Each 8 fluid ounce (237 mL) bottle contains acetaminophen, a pain reliever and fever reducer, and dextromethorphan HBr, a cough suppressant. This non-drowsy formulation effectively controls cough, soothes sore throat pain, and relieves fever and body aches. The product features a flavor profile that includes real honey and elderberry. It is intended for use in individuals aged 12 years and older. The product is identified by the UPC 62000000207916, as indicated on the front carton.

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, minor aches and pains, sore throat pain, and headache. Additionally, it is indicated for the temporary reduction of 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; it is essential to keep the dosing cup with the product at all times. 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, and for 2 weeks after discontinuation of the MAOI. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription drug, 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 essential 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, 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.

Consultation Requirements Healthcare professionals should advise patients to consult a doctor promptly if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Contraindications This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for 2 weeks following the cessation of an MAOI. Patients uncertain about whether their prescription includes an MAOI should be directed to consult a doctor or pharmacist. Additionally, this product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, a consultation with a healthcare professional is recommended.

Pre-existing Conditions Patients should seek medical advice before using this product if they have liver disease, a cough associated with excessive phlegm (mucus), or any breathing problems, including chronic cough related to smoking, asthma, or emphysema. Furthermore, individuals taking the anticoagulant warfarin or any other pain reliever/fever reducer should also consult a healthcare professional prior to use.

Emergency Situations In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation of Use Patients are 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 condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses within a 24-hour period, use the product in conjunction with other medications containing acetaminophen, or consume three 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 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 pain or cough worsens or lasts longer 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, as these may indicate a serious condition.

Before using this product, patients with liver disease, those experiencing a cough with excessive phlegm, or individuals with breathing problems or chronic coughs related to smoking, asthma, or emphysema should seek medical advice. Additionally, patients taking the blood-thinning medication warfarin or any other pain reliever or fever reducer should consult a doctor or pharmacist prior to use.

Drug Interactions

Co-administration of this product with a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications used for depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This product should not be used during treatment with an MAOI or within 2 weeks of discontinuing an MAOI.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated due to the risk of acetaminophen overdose.

The use of this product alongside warfarin, a blood-thinning medication, may elevate the risk of bleeding. Therefore, careful monitoring of bleeding parameters is advised when these agents are used together.

Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this product if they are taking any other pain reliever or fever reducer to avoid potential interactions.

Packaging & NDC

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

Packaging configurations for Robitussin Honey Severe Cough, Flu Plus Sore Throat.
Details

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 require careful consideration when prescribing this adult product, as it is not intended for use in children under 12 years of age. While specific dosage adjustments for geriatric patients are not provided, healthcare providers should exercise caution and closely monitor this population for any potential adverse effects or changes in efficacy. It is essential to evaluate the overall health status and comorbidities of elderly patients, as these factors may influence the safety and effectiveness of the treatment. Regular assessment and appropriate dose modifications may be necessary to ensure optimal therapeutic outcomes in this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 medication 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that 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 this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these individuals to prevent potential adverse effects associated with acetaminophen use.

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 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 care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any specific information. Furthermore, there is no information available related to animal pharmacology and toxicology.

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. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Additionally, healthcare providers should instruct patients to adhere strictly to the recommended dosage and to avoid using more than directed. This guidance is crucial to ensure the safe and effective use of the product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not recommended for this product. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. Additionally, it is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is necessary for both adults and children, regardless of the presence of symptoms.

For information regarding the potential for medicine abuse among teens, resources are available at www.StopMedicineAbuse.org. No further details are provided regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Robitussin Honey Severe Cough, Flu Plus Sore Throat, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.