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Robitussin Chest Congestion

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This product has been discontinued

Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2004
Label revision date
December 4, 2019
Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2004
Label revision date
December 4, 2019
Manufacturer
Wyeth Consumer Healthcare LLC
NDC root
0031-8748

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Drug Overview

Robitussin® is a medication that contains guaifenesin (an expectorant), which helps to relieve coughs caused by colds or flu. It works by thinning and loosening mucus in the airways, making it easier for you to cough up and clear out the mucus from your lungs. This can help improve your breathing and make you feel more comfortable when you're dealing with a cough.

Robitussin® is typically used for adults and children aged 12 years and older, with specific dosing instructions for different age groups. It's important to follow the recommended dosage to ensure safe and effective use.

Uses

Guaifenesin is a medication that serves as an expectorant, which means it helps to loosen mucus in your airways, making it easier to cough up and clear out. This can be particularly helpful when you're dealing with conditions that cause congestion, such as colds or respiratory infections.

It's important to note that there are no specific teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects mentioned for guaifenesin, indicating that it does not have known harmful effects in these areas. Always consult with a healthcare professional if you have questions about using this medication.

Dosage and Administration

When taking this medication, you should follow the recommended dosage carefully. For adults and children aged 12 years and older, the typical dose is 2 to 4 teaspoonfuls taken every 4 hours. If you are giving this medication to a child between the ages of 6 and under 12 years, the dose is reduced to 1 to 2 teaspoonfuls every 4 hours. However, it’s important to note that this medication should not be used for children under 6 years of age.

You will take this medication orally, which means you should swallow it. Make sure to adhere to the timing of every 4 hours to ensure the best results. Always consult with a healthcare professional if you have any questions or concerns about the dosage or administration.

What to Avoid

It's important to follow specific guidelines when using this medication. You should not use it if you are a child under 6 years old. Additionally, make sure to never exceed the recommended dosage, as doing so can lead to unwanted effects. If the breakable ring is separated, do not use the product.

There are no concerns regarding controlled substances, abuse, misuse, or dependence with this medication, but adhering to these instructions is crucial for your safety.

Side Effects

You may experience some common side effects, including dizziness, headache, nausea, and vomiting. Additionally, allergic reactions such as rash, itching, and swelling can occur, and in rare cases, severe allergic reactions (anaphylaxis) have been reported. Some people may also experience gastrointestinal issues like diarrhea, and there have been rare instances of skin reactions, including a serious condition called Stevens-Johnson syndrome. It's important to note that there have been rare reports of liver injury as well.

To minimize the risk of side effects, be sure to follow the recommended dosage, as exceeding it may lead to increased adverse reactions. If you notice any unusual symptoms, it's best to consult with your healthcare provider.

Warnings and Precautions

It's important to follow the recommended dosage for this medication and not exceed it, as doing so can lead to serious health issues. Always take the medication as directed by your healthcare provider to ensure your safety and effectiveness of the treatment.

Currently, there are no specific general precautions or laboratory tests required for monitoring while using this medication. However, if you experience any unusual symptoms or have concerns about your health while taking it, please consult your doctor for guidance.

Overdose

It's important to always follow the recommended dosage for any medication. Taking more than the advised amount can lead to an overdose, which can be serious. Signs of an overdose may include unusual symptoms that you should be aware of.

If you suspect that you or someone else has taken too much of a medication, seek immediate medical help. It's crucial to act quickly, as timely intervention can make a significant difference in outcomes. Always remember, when in doubt, it's better to consult a healthcare professional.

Pregnancy Use

When it comes to using Robitussin Chest Congestion (guaifenesin liquid) during pregnancy, there is currently no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the effects of this medication on you and your developing baby are not well-studied or documented.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before taking any medication, including over-the-counter products like Robitussin. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding, it's important to know that guaifenesin, a common medication, may be present in your breast milk. However, there isn't enough information available about how this medication might affect your nursing infant. Because of this uncertainty, it's recommended that you exercise caution when considering the use of guaifenesin while breastfeeding. Always consult with your healthcare provider to discuss any potential risks and to ensure the safety of both you and your baby.

Pediatric Use

When it comes to giving this medication to children, it's important to follow specific guidelines. For kids aged 6 to under 12 years, you can administer 1 to 2 teaspoonfuls every 4 hours as needed. However, if your child is under 6 years old, you should not use this medication at all.

Always ensure you are measuring the dosage accurately and consult with your child's healthcare provider if you have any questions or concerns about their treatment.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert for Robitussin Chest Congestion (guaifenesin liquid) does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for 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 your kidney function may influence how your body processes medications. Always prioritize open communication with your doctor about any concerns you have regarding your kidney health and medication use.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert for Robitussin Chest Congestion (guaifenesin liquid) does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have liver impairment.

Before using this medication, it’s a good idea to consult with your healthcare provider to ensure it’s safe for you, especially since they can offer personalized advice based on your health status.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

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 okay if the temperature occasionally ranges from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep it tightly closed when not in use.

Once you open the product, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains effective for your needs.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Robitussin®?

Robitussin® is a guaifenesin syrup, classified as an expectorant, used to help relieve chest congestion.

What is the adult dosage for Robitussin®?

The adult dose is 2 to 4 teaspoonfuls every 4 hours for individuals 12 years and older.

What is the dosage for children aged 6 to under 12 years?

Children aged 6 to under 12 years should take 1 to 2 teaspoonfuls every 4 hours.

Can children under 6 years use Robitussin®?

No, Robitussin® should not be used in children under 6 years.

What are common side effects of Robitussin®?

Common side effects include dizziness, headache, nausea, and vomiting.

What should I do if I experience an allergic reaction?

If you experience an allergic reaction such as rash, itching, or swelling, seek medical attention immediately.

Are there any warnings associated with Robitussin®?

You should not exceed the recommended dosage, as it may lead to increased side effects.

Is there any information about using Robitussin® during pregnancy?

There is no specific information regarding the use of Robitussin® during pregnancy.

What precautions should nursing mothers take?

Nursing mothers should be cautious, as guaifenesin may be excreted in breast milk, and there is insufficient data on its effects on nursing infants.

How should Robitussin® be stored?

Store Robitussin® at 20°C to 25°C (68°F to 77°F) and protect it from light. Keep it tightly closed and discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Robitussin Chest Congestion (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Robitussin Chest Congestion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Robitussin® is a guaifenesin syrup, classified as an expectorant. It is presented in a dosage form of 4 fluid ounces (118 mL).

Uses and Indications

Guaifenesin is indicated for use as an expectorant to facilitate the clearance of mucus from the airways, thereby aiding in the relief of cough associated with respiratory conditions.

There are no specific teratogenic or nonteratogenic effects associated with guaifenesin.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 to 4 teaspoonfuls administered orally every 4 hours as needed. For children aged 6 years to under 12 years, the dosage is 1 to 2 teaspoonfuls orally every 4 hours as required. It is important to note that this medication is not indicated for use in children under 6 years of age.

Administration should be performed orally, ensuring that the appropriate dosage is measured accurately for each individual based on age and weight considerations.

Contraindications

Use is contraindicated in the following situations:

  • The product should not be used in children under 6 years of age.

  • Do not exceed the recommended dosage.

  • If the breakable ring is separated, the product should not be used.

Warnings and Precautions

The recommended dosage should not be exceeded, as doing so may lead to adverse effects. Healthcare professionals are advised to monitor patients closely to ensure adherence to the prescribed dosage guidelines.

No additional general precautions or laboratory tests have been specified in the available data. It is essential for healthcare providers to remain vigilant and assess the patient's response to treatment regularly.

In the event of any concerning symptoms or adverse reactions, it is imperative for patients to seek emergency medical assistance promptly. Furthermore, if any unexpected side effects occur, patients should discontinue use and consult their healthcare provider for further guidance.

Side Effects

Patients may experience a range of adverse reactions while using the medication. Common adverse reactions reported include dizziness, headache, nausea, and vomiting.

In addition to these common reactions, other adverse events have been noted. Patients may experience allergic reactions, which can manifest as rash, itching, and swelling. Severe allergic reactions, including anaphylaxis, have also been reported. Gastrointestinal disturbances, such as diarrhea, are additional concerns.

There have been rare cases of skin reactions, including Stevens-Johnson syndrome, as well as rare instances of liver injury reported in postmarketing experience.

It is important to note that exceeding the recommended dosage may lead to an increase in side effects. Therefore, adherence to the prescribed dosage is crucial for minimizing the risk of adverse reactions.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Chest Congestion (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Robitussin Chest Congestion.
Details

Pediatric Use

Pediatric patients aged 6 years to under 12 years may be administered 1 to 2 teaspoonfuls every 4 hours. The use of this medication is not recommended for children under 6 years of age.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Robitussin Chest Congestion (guaifenesin liquid) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential. It is advisable to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

Nursing mothers should be aware of the potential for excretion of guaifenesin in breast milk. There is insufficient data on the effects of guaifenesin on a nursing infant. Caution is advised when administering this medication to nursing mothers.

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 Chest Congestion (guaifenesin liquid). Healthcare professionals should exercise caution and consider the lack of data 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 Chest Congestion (guaifenesin liquid). 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, as the absence of data necessitates careful consideration of individual patient circumstances.

Overdosage

Overdosage of the medication can lead to serious health consequences. It is imperative that healthcare professionals adhere strictly to the recommended dosage guidelines to mitigate the risk of overdosage.

Recommended Actions

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers are advised to monitor the patient closely for any signs of adverse effects and to initiate appropriate interventions as necessary.

Potential Symptoms

Symptoms of overdosage may vary depending on the specific medication involved but can include a range of physiological and psychological manifestations. It is crucial for healthcare professionals to be vigilant and recognize these symptoms promptly to ensure timely management.

Management Procedures

Management of overdosage should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. Continuous monitoring of vital signs and laboratory parameters is recommended to assess the patient's condition and guide further treatment decisions.

In summary, adherence to the recommended dosage is essential to prevent overdosage and its associated complications. Healthcare professionals must remain alert to the signs of overdosage and be prepared to act swiftly to ensure patient safety.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage of the medication. For adults and children aged 12 years and over, the appropriate dose is 2 to 4 teaspoonfuls every 4 hours. For children aged 6 years to under 12 years, the recommended dose is 1 to 2 teaspoonfuls every 4 hours. It is important to inform patients that the medication should not be used in children under 6 years of age.

Additionally, healthcare providers should emphasize the importance of the tamper-evident bottle cap. Patients should be instructed that if the breakable ring is separated, the product should not be used. This precaution helps ensure the safety and integrity of the medication.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

To ensure product integrity, it must be protected from light and kept tightly closed. Additionally, any unused portion should be discarded after opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Robitussin Chest Congestion, 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 Chest Congestion, 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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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.