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Robitussin Tos Seca

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Active ingredient
Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Dosage form
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1996
Label revision date
April 24, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Dosage form
Syrup
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 1996
Label revision date
April 24, 2024
Manufacturer
Haleon US Holdings LLC
NDC root
0031-8652
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Robitussin® is a cough syrup that contains dextromethorphan hydrobromide (10 mg per 5 mL), which is a medication used to help relieve coughing. It also includes natural honey, which can provide soothing properties for your throat. This product is designed to help protect your throat while alleviating the discomfort associated with coughing.

Uses

Robitussin is a cough suppressant that contains dextromethorphan bromide. You can use it to help relieve coughing that comes from minor irritation in your throat and bronchial tubes. This can be particularly helpful when you're dealing with a dry cough that disrupts your day-to-day activities.

It's important to note that there are no specific concerns regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects associated with Robitussin. This means that, based on available information, it does not appear to pose risks in these areas.

Dosage and Administration

When you need to take this medication, you will be using it orally, which means you will swallow it. The active ingredient in this medication is dextromethorphan hydrobromide, and it comes in a strength of 10 mg for every 5 mL of the liquid.

To use the medication, simply measure out the appropriate amount and take it by mouth as directed. Make sure to follow the instructions provided by your healthcare provider regarding how often to take it. Always ensure you are using the correct dosage to achieve the best results safely.

What to Avoid

It seems that the information regarding what to avoid while using this medication is not specified in the provided text. Therefore, I recommend that you consult your healthcare provider or the medication's official guidelines for detailed information on contraindications, controlled substance classifications, risks of abuse or misuse, dependence issues, and any specific instructions on what not to take or use. Your safety and well-being are important, so it's essential to have clear guidance from a trusted source.

Side Effects

You may experience some side effects while taking this medication. Common reactions include drowsiness, nausea, vomiting, stomach pain, constipation, dry mouth, and confusion. In some cases, you might also experience agitation, hallucinations, or a rash. It's important to be aware that serious side effects can occur, including severe allergic reactions, which may lead to anaphylaxis (a life-threatening allergic response).

Additionally, there have been rare reports of severe skin reactions after the medication has been on the market. If you notice any unusual or severe symptoms, please contact your healthcare provider promptly.

Warnings and Precautions

It seems that the specific warnings, precautions, and instructions for emergency help or stopping use are not provided in the information available. However, it’s always important to be aware of potential side effects and to communicate openly with your healthcare provider about any concerns you may have while using a medication.

If you experience any unusual symptoms or reactions, it’s crucial to stop taking the medication and contact your doctor immediately. Additionally, if you ever feel that you need urgent medical assistance, don’t hesitate to seek emergency help. Regular check-ins with your healthcare provider can also help ensure that the medication is working safely and effectively for you.

Overdose

If you take too much dextromethorphan hydrobromide, you might experience symptoms like confusion, nervousness, irritability, restlessness, drowsiness, and nausea. In more serious cases, an overdose can cause respiratory depression (slowed breathing), hallucinations, or even coma.

If you suspect an overdose, it’s crucial to seek emergency medical help right away. Don’t wait for symptoms to worsen; getting prompt assistance can be vital for your safety.

Pregnancy Use

It’s important to know that the safety of this medication during pregnancy has not been established. Because of potential risks to the developing fetus, it is not recommended for use while you are pregnant. If you are planning to become pregnant or are currently pregnant, please consult your healthcare provider for guidance and to discuss any concerns you may have. Your health and the health of your baby are the top priority.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 4 years old. For children aged 4 years and older, you should consult a physician to determine the right dosage. Always prioritize your child's safety by seeking professional guidance before administering any medication.

Geriatric Use

When considering medication for older adults, it's important to proceed with caution, as specific studies on geriatric use have not been conducted. You should be aware that older adults may have reduced kidney function, which can impact how the body processes and eliminates the medication. This means that the drug may stay in the system longer, potentially leading to increased effects or side effects.

Additionally, older adults may be more sensitive to the side effects of medications. It's essential to monitor for any unusual reactions and consult with a healthcare provider to ensure the safest and most effective use of the medication. Always discuss any concerns or questions with a doctor, especially regarding dosage adjustments or potential interactions with other medications.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert for Robitussin TOS SECA (dextromethorphan hydrobromide syrup) does not provide specific information about dosage adjustments or special monitoring for your condition. This means that there are no established guidelines regarding how this medication may affect you if you have renal impairment (kidney issues).

Before using this medication, it’s a good idea to consult with your healthcare provider to ensure it’s safe for you, especially since individual health needs can vary. Your doctor can help determine the best approach for managing your symptoms while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert for Robitussin TOS SECA (dextromethorphan hydrobromide syrup) does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication should be used if you have liver impairment.

Before taking this medication, you should consult with your healthcare provider to discuss your liver health and any potential risks. They can help determine the best course of action for your treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or changes in your health with your doctor or pharmacist. They can provide personalized advice and help you avoid any potential issues, even if no specific interactions are listed. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to protect it from light to maintain its effectiveness. When you're not using the bottle, make sure to keep it tightly closed to prevent contamination. Remember to discard the product after opening to ensure safety and efficacy. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Robitussin®?

Robitussin® is an antitussive (cough suppressant) syrup that contains dextromethorphan bromide and natural honey.

What are the indications for using Robitussin®?

Robitussin® is indicated to relieve cough associated with minor throat and bronchial irritation.

What is the recommended dosage for Robitussin®?

The recommended dosage is 10 mg of dextromethorphan hydrobromide in 5 mL, administered orally.

What are the possible side effects of Robitussin®?

Possible side effects include drowsiness, nausea, vomiting, stomach pain, constipation, dry mouth, confusion, hallucinations, agitation, rash, and allergic reactions.

Are there any warnings associated with Robitussin®?

Yes, serious side effects may occur, including severe allergic reactions.

Is Robitussin® safe for use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use due to potential risks to the fetus.

Can children use Robitussin®?

Robitussin® should not be used in children under 4 years of age. Consult a physician for appropriate dosing for children aged 4 years and older.

What should I do if I experience severe side effects?

If you experience severe side effects, including allergic reactions, seek emergency medical help immediately.

How should Robitussin® be stored?

Store Robitussin® at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the bottle tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Robitussin Tos Seca (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Robitussin Tos Seca.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Robitussin® dem TOS SECA ANTITUSIVO CON MIEL is a cough syrup formulation containing dextromethorphan bromide at a concentration of 10 mg per 5 mL. This product includes natural honey as an ingredient, which contributes to its soothing properties. The formulation is designed to protect the throat. The net content of the product is 118 mL, and it is identified by the code CPE0309165373.

Uses and Indications

Robitussin is indicated as an antitussive (cough suppressant) containing dextromethorphan bromide. This medication is utilized to relieve cough associated with minor throat and bronchial irritation.

There are no specific teratogenic or nonteratogenic effects associated with the use of Robitussin.

Dosage and Administration

The active ingredient in this formulation is dextromethorphan hydrobromide, with a strength of 10 mg per 5 mL. The medication is to be administered orally.

Healthcare professionals should ensure that the dosage is measured accurately using an appropriate measuring device. It is important to follow the prescribed dosing regimen and to monitor the patient for any adverse effects or therapeutic response.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment and consider individual patient circumstances when prescribing.

Warnings and Precautions

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

It is essential to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular laboratory tests may be necessary to assess the patient's response to therapy and to ensure safety. Specific monitoring parameters should be established based on the individual patient's health status and the medication's profile.

In the event of severe side effects or unexpected reactions, immediate medical attention should be sought. Healthcare providers should instruct patients to discontinue use and contact their physician if they experience any concerning symptoms.

Overall, a thorough understanding of the potential risks and the implementation of appropriate monitoring strategies are vital for the safe administration of this medication.

Side Effects

Patients may experience a range of adverse reactions while using the medication. Common adverse reactions include drowsiness, nausea, vomiting, stomach pain, constipation, dry mouth, and rash.

Serious adverse reactions have been reported, including severe allergic reactions, which may manifest as anaphylaxis. Additionally, participants have experienced confusion, hallucinations, and agitation.

Postmarketing experience has indicated rare occurrences of severe skin reactions, underscoring the importance of monitoring for any unusual symptoms following administration. It is essential for healthcare providers to be aware of these potential adverse reactions to ensure patient safety and appropriate management.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Tos Seca (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Robitussin Tos Seca.
Details

Pediatric Use

Pediatric use is not established for children under 4 years of age, and the medication is contraindicated in this population. For pediatric patients aged 4 years and older, it is essential to consult a physician to determine the appropriate dosing.

Geriatric Use

Caution should be exercised when administering this medication to elderly patients, as geriatric use has not been specifically studied. It is important to consider that elderly patients may have reduced kidney function, which could impact the metabolism and excretion of the drug. Additionally, increased sensitivity to side effects may be observed in this population. Therefore, careful monitoring and potential dose adjustments may be necessary to ensure safety and efficacy in geriatric patients.

Pregnancy

Safety during pregnancy has not been established for this medication. It is not recommended for use during pregnancy due to potential risks to the fetus. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to pregnant patients or women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for Robitussin TOS SECA (dextromethorphan hydrobromide syrup). Healthcare professionals should exercise caution and consider individual patient factors when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of Robitussin TOS SECA (dextromethorphan hydrobromide syrup). Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for this population. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with compromised liver function, given the lack of data on its safety and efficacy in such individuals.

Overdosage

Overdosage of dextromethorphan hydrobromide can manifest with a range of symptoms that may vary in severity. Initial signs may include confusion, excitation, nervousness, irritability, restlessness, drowsiness, and nausea. In more severe instances, the clinical presentation may escalate to respiratory depression, hallucinations, and even coma.

In the event of a suspected overdose, it is imperative to seek emergency medical attention without delay. Prompt intervention is crucial to manage the potential complications associated with overdosage effectively. Healthcare professionals should be prepared to provide supportive care and monitor the patient closely for any progression of symptoms.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to use this medication in conjunction with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing such treatment, as this may lead to serious interactions.

Patients should be encouraged to consult their doctor prior to use if they have a cough that produces excessive phlegm (mucus), a chronic cough, or a cough that persists for more than 7 days. It is important for patients to be aware that they should stop using the medication and seek medical advice if their cough lasts longer than 7 days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache.

Providers should emphasize the importance of keeping the medication out of reach of children. In the event of an overdose, patients must be instructed to seek medical help or contact a Poison Control Center immediately.

Finally, healthcare providers should remind patients not to exceed the recommended dose to avoid potential adverse effects.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Robitussin Tos Seca, 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 Tos Seca, 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.

Learn more in our Editorial Policy

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Primary FDA sources:

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.