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Always Save Chest Congestion Relief

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Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
December 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
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 2022
Label revision date
December 17, 2024
Manufacturer
Valu Merch
Registration number
M012
NDC root
63941-987
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

This medication is designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, it helps make your coughs more productive, allowing you to expel bothersome mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve congestion.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways.

Additionally, it makes your coughs more productive, meaning that when you do cough, it can help you expel mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve mucus buildup.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 hours as needed for relief. For children aged 6 to 10 years, the recommended dose is 1/2 tablet every 4 hours, also as needed. However, if your child is under 6 years old, it’s important to consult a doctor before giving them this medication.

Make sure not to exceed 6 doses in a 24-hour period, unless your doctor advises otherwise. This helps ensure safe and effective use of the medication. Always follow these guidelines to manage your or your child's symptoms properly.

What to Avoid

It's important to use this medication safely. Always keep it out of reach of children to prevent accidental ingestion. If you experience symptoms like fever, rash, or a persistent headache, stop using the medication and consult your doctor. Additionally, if your cough lasts more than a week or keeps coming back, it's best to stop using it and seek medical advice. Your health and safety are paramount, so don't hesitate to reach out to a healthcare professional if you have any concerns.

Side Effects

If you are considering using this medication, it's important to consult your doctor first if you have a persistent or chronic cough, especially if it’s related to smoking, asthma, bronchitis, or emphysema. Additionally, if your cough comes with excessive mucus, you should also seek medical advice.

You should stop using the medication and contact your doctor if you experience symptoms like fever, rash, or a persistent headache. If your cough lasts more than a week or keeps coming back, it may indicate a more serious health issue that needs attention.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent or chronic cough, especially if it's related to smoking, asthma, bronchitis, or emphysema. Additionally, if your cough comes with excessive phlegm (mucus), you should also seek medical advice.

To ensure safety, keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center right away.

You should stop taking this medication and call your doctor if you experience symptoms like fever, rash, or a persistent headache. Also, if your cough lasts more than a week or keeps coming back, it's crucial to consult your doctor, as this could indicate a more serious health issue.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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

When giving this medication to children, it's important to follow the recommended dosages based on their age. For children aged 12 and older, you can give them 1 tablet every 4 hours as needed. If your child is between 6 and 10 years old, the dosage is 1/2 tablet every 4 hours. For children under 6 years of age, you should consult a doctor before administering the medication.

Make sure not to exceed 6 doses in a 24-hour period, unless directed otherwise by a healthcare professional. Always keep these guidelines in mind to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney 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 for the medication do not change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

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 determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want 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 great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°-30°C (59°-86°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

For adults and children aged 12 and over, you should take 1 tablet every 4 hours as needed, but do not exceed 6 doses in a 24-hour period unless directed by a doctor. If you are giving this medication to children aged 6 to 10, they should take 1/2 tablet every 4 hours as needed. For children under 6 years old, it's important to consult a doctor before administering the medication.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

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

Adults and children 12 years of age and over should take 1 tablet every 4 hours as needed, not exceeding 6 doses in a 24-hour period.

What is the dosage for children aged 6 to 10?

Children aged 6 to 10 should take 1/2 tablet every 4 hours as needed, also not exceeding 6 doses in a 24-hour period.

What should I do if my child is under 6 years old?

If your child is under 6 years of age, you should consult a doctor before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if I experience side effects?

Stop use and ask a doctor if symptoms are accompanied by fever, rash, or persistent headache, or if a cough persists for more than 1 week.

Is this drug safe to use during pregnancy or breastfeeding?

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

What precautions should I take when using this drug?

Keep this drug out of reach of children and seek medical help in case of overdose.

What should I do if I have a persistent cough?

You should ask a doctor before use if you have a persistent or chronic cough, especially if it is accompanied by excessive phlegm.

What is the storage requirement for this drug?

Store the drug at 15°-30°C (59°-86°F).

Packaging Info

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

Packaging configurations for Always Save Chest Congestion Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production in the respiratory tract. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication aids in making coughs more productive, thereby improving respiratory function.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that children under 6 years of age consult a doctor before administration.

Healthcare professionals should advise patients not to exceed 6 doses in a 24-hour period, unless otherwise directed by a physician.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children.

Patients should discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, medical advice should be sought.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this medication. Prior to use, patients should be advised to consult their healthcare provider if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Additionally, patients should be informed that the presence of excessive phlegm (mucus) accompanying the cough warrants medical consultation.

It is imperative to keep this medication out of reach of children to prevent accidental ingestion. 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 any of the following occur: symptoms are accompanied by fever, rash, or a persistent headache; the cough persists for more than one week; or if the cough tends to recur. A persistent cough may indicate an underlying serious condition that requires further evaluation and management.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice.

It is important for patients to discontinue use and contact a healthcare provider if symptoms are accompanied by fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, medical consultation is recommended, as a persistent cough may indicate a serious underlying condition.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Always Save Chest Congestion Relief.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 1 tablet every 4 hours as needed, with a maximum of 6 doses in a 24-hour period or as directed by a healthcare professional. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed, also not to exceed 6 doses in a 24-hour period or as directed.

For children under 6 years of age, consultation with a doctor is advised prior to administration.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management strategies tailored to the individual case.

Overall, vigilance and prompt intervention are critical in managing potential overdosage situations effectively.

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 to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult their doctor if they experience symptoms accompanied by fever, rash, or a persistent headache. Additionally, they should be cautioned to stop use and seek medical advice if their cough persists for more than one week or tends to recur, as a persistent cough may indicate a serious underlying condition.

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) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 hours as needed, while children aged 6 to 10 years should take 1/2 tablet every 4 hours as needed. For children under 6 years of age, consultation with a doctor is recommended. It is important for patients to not exceed 6 doses within a 24-hour period unless directed by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Always Save Chest Congestion Relief, 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 Always Save Chest Congestion Relief, 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.