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Guaifenesin 400

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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 2021
Label revision date
October 2, 2025
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 2021
Label revision date
October 2, 2025
Manufacturer
InvaTech Pharma Solutions LLC
Registration number
M012
NDC root
57631-012
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

Sennosides Tablets USP are a type of medication that contain 25 mg of sennosides, which are natural compounds derived from the senna plant. These tablets are primarily used to relieve constipation by stimulating bowel movements. They work by increasing the activity of the intestines, helping to move stool through the digestive tract more effectively.

While sennosides are mainly known for their use in treating constipation, they may also be mentioned in the context of other conditions, such as cough and cold, although their primary function is related to digestive health. If you're considering using Sennosides Tablets, it's important to understand their role in promoting regularity and supporting your overall digestive wellness.

Uses

You may use this medication to help relieve symptoms associated with cough and cold. It can provide you with some comfort when you're feeling under the weather, helping to ease your discomfort.

There are no known risks of teratogenic effects (which means it doesn't cause birth defects) or other nonteratogenic effects associated with this medication. Always consult with your healthcare provider if you have any questions or concerns about its use.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how to take it, or how often to use it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized advice based on your health needs.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's instructions and reach out to them if you have any questions or concerns about your treatment.

Side Effects

You may not experience any specific side effects or warnings while using this medication. There are no additional adverse reactions or important notes to be aware of. Always consult with your healthcare provider if you have any concerns or experience unusual symptoms.

Warnings and Precautions

You can feel reassured that there are no specific warnings or precautions associated with this medication. It is also important to note that no laboratory tests are required for safe use, which simplifies your experience.

Since there are no emergency help instructions or recommendations to stop taking the medication and call your doctor, you can use it with confidence. However, if you ever have concerns or experience unusual symptoms, it’s always a good idea to consult with your healthcare provider.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical attention.

In case of an emergency, you should call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. It is generally not recommended for use in pregnant women due to potential risks to the developing fetus. Before considering this medication, you should consult your healthcare provider to discuss any possible risks and to ensure the best care for you and your baby.

There are no specific dosage adjustments provided for pregnant patients, so it's crucial to seek medical advice before using this medication. Always prioritize open communication with your healthcare provider to make informed decisions regarding your health and pregnancy.

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 best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

When considering Guaifenesin 400 mg tablets for your child, it's important to note that the safety and effectiveness of this medication in children have not been established. This means that there hasn't been enough research to confirm whether it is safe or works well for pediatric patients. Therefore, you should consult with a healthcare professional before giving this medication to your child to ensure their safety and well-being.

Geriatric Use

As you age, your body may respond differently to medications, including guaifenesin. Older adults often have increased sensitivity to the side effects of this medication, which means you might experience them more intensely than younger individuals. Additionally, if you have reduced kidney function (the ability of your kidneys to filter waste), your doctor may need to adjust the dosage to ensure it's safe and effective for you.

It's important to note that the safety and effectiveness of guaifenesin in older adults have not been fully established. Therefore, if you or a loved one is considering this medication, it's essential to discuss any concerns with your healthcare provider to ensure the best care tailored to your needs.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, you may require a lower dose of your medication. Additionally, if you have severe renal impairment, special care should be taken regarding your treatment plan. Always consult your healthcare provider for personalized advice and adjustments based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care 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 and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light and always keep the container tightly closed when not in use to maintain its integrity.

When handling the product, be mindful of these storage conditions to ensure safety and effectiveness. Proper storage and handling will help you get the most out of your device.

Additional Information

No further information is available.

FAQ

What is Sennosides Tablets USP used for?

Sennosides Tablets USP are indicated for the treatment of cough and cold.

Are there any contraindications for using Sennosides Tablets?

No contraindications are listed for Sennosides Tablets.

Is Sennosides safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use in pregnant women due to potential risks.

What should I know about using Sennosides if I have renal impairment?

Patients with renal impairment may require dosage adjustments, and renal function tests should be monitored regularly.

What are the storage conditions for Sennosides Tablets?

Store Sennosides Tablets at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F), and protect from light.

Are there any side effects or warnings associated with Sennosides Tablets?

No specific side effects or warnings are provided in the insert.

Can Sennosides Tablets be used in pediatric patients?

Pediatric use has not been established, and safety and effectiveness in children have not been determined.

What precautions should be taken for geriatric patients using Sennosides?

Geriatric patients may have increased sensitivity to side effects, and dosage adjustments may be necessary due to potential reduced kidney function.

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin 400 (guaifenesin tablets 400). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 400.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin 400, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with cough and cold.

There are no known teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this product as outlined in the insert. Healthcare professionals should be aware that no general precautions have been provided, and there are no recommended laboratory tests necessary for the safe use of this medication.

In the event of an adverse reaction or concern, it is advisable for healthcare providers to exercise clinical judgment and consider the patient's overall health status. However, the insert does not specify any emergency medical help instructions or guidance on when to discontinue use and consult a physician.

It is essential for healthcare professionals to remain vigilant and monitor patients for any unexpected effects, despite the absence of formal warnings or precautions in the product information.

Side Effects

There are no specific side effects or warnings associated with the use of this product. Additionally, no further adverse reactions or important notes have been identified in clinical trials or postmarketing experiences. As such, the safety profile remains unremarkable, with no reported adverse events in the available data.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin 400 (guaifenesin tablets 400). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 400.
Details

Pediatric Use

Pediatric use of Guaifenesin 400 mg tablets has not been established. The safety and effectiveness of this medication in pediatric patients remain undetermined. Therefore, caution is advised when considering its use in children and adolescents.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of guaifenesin. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to ensure safety and efficacy. It is important to note that the safety and efficacy of guaifenesin in geriatric patients have not been established; therefore, caution is advised when prescribing this medication to elderly individuals. Regular monitoring and assessment of renal function may be warranted to mitigate risks associated with treatment in this demographic.

Pregnancy

Safety during pregnancy has not been established for this medication. Use is not recommended in pregnant women due to potential risks to the developing fetus. There may be risks associated with the use of this medication during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider before use. No specific dosage modifications are provided for pregnant patients. It is advised that pregnant women seek medical advice prior to using this medication to ensure the safety of both the mother and the fetus.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests regularly in these patients to ensure appropriate dosing and minimize the risk of adverse effects. Specifically, patients with a creatinine clearance of less than 30 mL/min may require a reduced dose. Special consideration should be given to patients with severe renal impairment to ensure their safety and the efficacy of treatment.

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 outlined 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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient, including vital signs and level of consciousness.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If the overdose is recent and the patient is alert, consider activated charcoal administration, provided there are no contraindications.

  4. Specific Antidotes: If applicable, administer specific antidotes based on the substance involved in the overdose.

  5. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is essential to detect any deterioration promptly.

Healthcare professionals should consult local poison control centers or toxicology experts for guidance on management protocols specific to the substance involved in the overdose. Documentation of the incident and all interventions performed is also critical for ongoing patient care and legal purposes.

In summary, while no specific overdosage information is provided, healthcare professionals must be prepared to act swiftly and effectively in the event of an overdose, utilizing established protocols and resources to ensure optimal patient outcomes.

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 use of the compound in these contexts.

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 or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from the sight and reach of children, to ensure their safety.

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). It is essential to protect the product from light and ensure that the container remains tightly closed to maintain its integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Guaifenesin 400, 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 Guaifenesin 400, 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.