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Rompe Pecho

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Active ingredient
Guaifenesin 200 mg/10 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
November 14, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 200 mg/10 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
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 2015
Label revision date
November 14, 2024
Manufacturer
Efficient Laboratories Inc
Registration number
M012
NDC root
58593-829
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

You may be interested to know that this medication helps loosen phlegm (mucus) and thins bronchial secretions. This action makes it easier for you to clear out bothersome mucus from your bronchial passageways, which can be particularly helpful if you're dealing with respiratory issues. By improving mucus clearance, it supports better breathing and overall lung function.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it aids in clearing out the bronchial passageways of bothersome mucus, making it easier for you to cough it up and improve your respiratory comfort.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

When using this medication, it's important to follow the dosage instructions carefully. If you are an adult or a child aged 12 years and older, you should take 10 mL (which is equivalent to 2 teaspoonfuls) every 4 hours. However, make sure not to exceed more than 6 doses within a 24-hour period to avoid any potential risks.

Please note that this product is not intended for children under 12 years of age, so if you have younger children, do not use this medication for them. Always ensure you are following these guidelines to use the medication safely and effectively.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your cough lasts more than a week, comes back frequently, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any concerns.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not exceed the recommended dosage, as doing so can lead to serious health issues. If you have a persistent or chronic cough—like those caused by smoking, asthma, chronic bronchitis, or emphysema—or if your cough comes with excessive mucus, it's crucial to consult your doctor before using this medication. This will help ensure your safety and the effectiveness of your treatment.

Warnings and Precautions

It's important to follow the recommended dosage and not exceed it. If you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with a lot of mucus, please consult your doctor before using this medication.

If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, you should stop using the medication and call your doctor if your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, as these could be signs of a more serious condition.

Overdose

Taking more than the recommended dosage of a medication can lead to serious health risks. It's important to always follow the dosage instructions provided by your healthcare provider or on the medication label. Exceeding this amount can result in an overdose, which may cause harmful effects.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always err on the side of caution—if you are unsure or feel unwell after taking your medication, contact a healthcare professional right away.

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 product is designed for adults and is not suitable for children under 12 years old. If you are 12 years or older, the recommended dosage is 10 mL (which is equivalent to 2 teaspoonfuls) every 4 hours as needed.

While there are no specific dosage adjustments mentioned for older adults, it's always wise to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, 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 issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15° and 30°C (59° and 86°F). It's important not to refrigerate the product, as this can affect its effectiveness.

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the main use of this drug?

This drug helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.

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

Adults and children 12 years and over should take 10 mL (2 teaspoonful) every 4 hours, not exceeding 6 doses in any 24-hour period.

Is this drug safe for children under 12?

No, this adult product is not intended for use in children under 12 years.

What should I do if my cough persists?

Stop use and ask a doctor if your cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.

Are there any warnings associated with this drug?

Do not exceed the recommended dosage and consult a doctor if you have a persistent or chronic cough, especially if it is accompanied by excessive phlegm.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Is there any information regarding use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What are the storage conditions for this drug?

Store between 15° - 30°C (59° - 86°F) and do not refrigerate.

Packaging Info

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

Packaging configurations for Rompe Pecho.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby aiding in the removal of bothersome mucus from the bronchial passageways.

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 administer a dosage of 10 mL (equivalent to 2 teaspoonfuls) every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

This product is specifically formulated for adult use and is not intended for children under 12 years of age. Healthcare professionals should ensure that patients are aware of these guidelines to promote safe and effective use.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

It is imperative that the recommended dosage is not exceeded to ensure patient safety and efficacy of treatment. Healthcare professionals should advise patients to consult a physician prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if the cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation and management.

Side Effects

Patients should be advised not to exceed the recommended dosage of the medication. It is important for individuals to consult a healthcare professional prior to use if they have a persistent or chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, caution is warranted if the cough is accompanied by excessive phlegm (mucus).

These precautions are essential to ensure the safe and effective use of the medication, minimizing the risk of adverse reactions associated with inappropriate use.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Rompe Pecho.
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 within this age group. Therefore, it is contraindicated for use in individuals under 12 years.

Geriatric Use

Elderly patients may utilize this adult product; however, it is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 10 mL (2 teaspoonfuls) every 4 hours.

While no specific geriatric use information or dosage adjustments have been provided, healthcare providers should exercise caution when prescribing this product to elderly patients. It is advisable to monitor for any potential adverse effects or changes in response to treatment, as older adults may have different pharmacokinetic and pharmacodynamic profiles compared to younger populations.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Exceeding the recommended dosage of the medication may lead to serious adverse effects. Healthcare professionals are advised to strictly adhere to the prescribed dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, it is crucial to monitor the patient closely for any potential symptoms that may arise. Symptoms of overdosage can vary depending on the specific medication involved and may include, but are not limited to, severe drowsiness, confusion, respiratory depression, or other significant neurological effects.

Management of overdosage should be initiated promptly. Healthcare providers should assess the patient's clinical status and consider supportive care measures. This may involve the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk of aspiration. Additionally, symptomatic treatment should be provided as necessary, and specific antidotes should be utilized if available and indicated.

It is essential for healthcare professionals to report any cases of overdosage to the appropriate regulatory authorities and to consult the product's prescribing information for further guidance on management protocols.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in nonclinical toxicology studies. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

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 15° to 30°C (59° to 86°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Rompe Pecho, 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 Rompe Pecho, 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

Last AI update:

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.