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Premier Value

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Active ingredients
  • Guaifenesin 200 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
October 28, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
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 2019
Label revision date
October 28, 2024
Manufacturer
PHARMACY VALUE ALLIANCE LLC
Registration number
M012
NDC root
68016-744
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

Premier Value Sugar Free Tussin DM is a specially formulated cough syrup designed for individuals aged 12 and over, particularly those with diabetes. It serves as both a cough suppressant and an expectorant, meaning it helps to temporarily relieve cough caused by minor throat and bronchial irritation, such as that which may occur with a cold. Additionally, it works to loosen phlegm (mucus) and thin bronchial secretions, making it easier to drain the bronchial tubes and relieve chest congestion.

This non-drowsy medication effectively controls cough and mucus, providing comfort during times of respiratory discomfort.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially from a cold, this medication can provide temporary relief. It works by soothing your throat and helping to ease the discomfort associated with coughing.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for your body to clear out the bronchial tubes. This can be particularly helpful when you're feeling congested and need to breathe more easily.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. For adults and children aged 12 years and older, the recommended dose is 20 milliliters (mL) every 4 hours. However, you should not take more than 6 doses within a 24-hour period. It's important to measure the dose using the dosing cup that comes with the product, and be sure to keep this cup with the medication for future use.

Please note that this product is not intended for children under 12 years of age, so if you have younger children, you should not use this medication for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you should not use this product for at least two weeks after stopping an MAOI. If you are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

It's important to follow these guidelines to prevent potential serious interactions and ensure your safety. Always prioritize open communication with your healthcare provider regarding any medications you are taking.

Side Effects

If you experience a persistent cough, it could indicate a serious condition, so it's important to pay attention to this symptom. You should stop using the medication and consult a doctor if your cough lasts more than 7 days, returns after improvement, or is accompanied by fever, rash, or a persistent headache.

Before using this medication, talk to your doctor if your cough is associated with excessive mucus or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. Your health and safety are important, so don’t hesitate to seek medical advice if you have any concerns.

Warnings and Precautions

If you are taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, do not use this product. You should also wait at least two weeks after stopping an MAOI before using it. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's important to be aware of your health while using this product. If your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or a persistent headache, stop using the product and contact your doctor. These symptoms could indicate a more serious condition.

In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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

It's important to know that this product is not suitable for children under 12 years old. If you are a parent or caregiver, please avoid using this adult product for younger children, as it is specifically designed for adults and may not be safe for kids. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

If you are caring for an older adult, it's important to note that this medication is not suitable for children under 12 years old. Always consult with a healthcare professional to ensure that the treatment is appropriate for the specific needs of older adults, as their bodies may process medications differently.

When considering medication for older adults, be aware of any potential changes in health, such as kidney function or cognitive abilities, which can affect how the medication works. Always follow the guidance of a healthcare provider regarding dosage and any necessary precautions.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. Regular monitoring of your renal function is essential, and this typically involves tests that measure creatinine clearance (a way to assess kidney function).

Before starting any new therapy, your healthcare provider will likely perform these renal function tests and continue to check your kidney health periodically. If you have severe renal impairment, special care will be taken to ensure your treatment is safe and effective. Always discuss any concerns with your healthcare provider to ensure you receive the best care tailored to your needs.

Hepatic Impairment

If you have liver problems, it's important to know that your condition can affect how your body processes certain medications. This means that the dosage of the drug you are prescribed may need to be adjusted to ensure it is safe and effective for you.

Your healthcare provider will likely monitor your liver function tests (which are blood tests that check how well your liver is working) to keep an eye on your liver health while you are taking the medication. Special precautions will be taken when administering the drug to ensure your safety, so be sure to communicate openly with your doctor about your liver condition.

Drug Interactions

It's crucial to be aware of potential interactions when taking any medication. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or certain psychiatric conditions, you should not take this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, it's important to consult with your doctor or pharmacist for clarification.

Always discuss your medications and any changes with your healthcare provider to ensure your safety and the effectiveness of your treatment. They can help you navigate any potential interactions and provide guidance tailored to your health needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to avoid refrigerating it, as this can affect its effectiveness. When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity and safety. Always follow these guidelines to ensure you are using the product correctly and safely.

Additional Information

You should take this medication orally, with adults and children aged 12 years and older advised to take 20 mL every 4 hours. However, do not exceed 6 doses in a 24-hour period. It's important to shake the bottle well before use and measure the dose using the provided dosing cup, which should be kept with the product. Please note that this medication is not intended for children under 12 years of age, and it should be stored at room temperature—do not refrigerate it.

FAQ

What is Premier Value Sugar Free Tussin DM used for?

Premier Value Sugar Free Tussin DM is a cough suppressant and expectorant that temporarily relieves cough due to minor throat and bronchial irritation, and helps loosen phlegm (mucus) to drain bronchial tubes.

Who can use Premier Value Sugar Free Tussin DM?

This product is intended for adults and children aged 12 years and over. It is not recommended for children under 12 years of age.

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

The recommended dosage is 20 mL every 4 hours, with a maximum of 6 doses in any 24-hour period.

Are there any contraindications for using this product?

Do not use if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.

What should I do if my cough persists?

If your cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, stop use and consult a doctor.

How should I store Premier Value Sugar Free Tussin DM?

Store the product at room temperature and do not refrigerate.

What should I do before using this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this product.

What are the side effects of Premier Value Sugar Free Tussin DM?

No specific side effects are mentioned, but you should stop use and consult a doctor if you experience a persistent cough or other concerning symptoms.

Packaging Info

Below are the non-prescription pack sizes of Premier Value (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Premier Value.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Premier Value Sugar Free Tussin DM is a cough suppressant and expectorant formulation specifically designed for diabetic patients. The active ingredients include Dextromethorphan HBr, which serves as the cough suppressant, and Guaifenesin, which acts as an expectorant. This product is non-drowsy and is intended for use by individuals aged 12 years and older. The dosage form is a liquid, and the product is available in a 4 fluid ounce (118 mL) container.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

The product should be shaken well before each use. For adults and children aged 12 years and older, the recommended dosage is 20 mL administered every 4 hours as needed. It is important to measure the dosage using only the dosing cup provided with the product, and to keep the dosing cup with the product at all times.

Healthcare professionals should advise patients not to exceed 6 doses within a 24-hour period. This product is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for a period of 2 weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm whether a patient’s prescription includes an MAOI by consulting with the patient or reviewing their medication history.

Patients should discontinue use and consult a healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by 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 may experience a range of adverse reactions associated with the use of this medication. A persistent cough may indicate a serious underlying condition, warranting immediate medical attention. Patients are advised to discontinue use and consult a healthcare professional if their cough lasts for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache.

Before initiating treatment, patients should seek medical advice if they have a cough that is productive with excessive phlegm (mucus) or if they have a chronic cough related to conditions such as smoking, asthma, chronic bronchitis, or emphysema. These considerations are crucial to ensure the safe and effective use of the medication.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Premier Value (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Premier Value.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this product, as it is not intended for this age group. Safety and efficacy have not been established in children under 12, and therefore, healthcare professionals are advised to avoid prescribing this adult formulation to pediatric patients in this age range.

Geriatric Use

Elderly patients may require careful consideration when using this adult product, which is not intended for use in children under 12 years of age. While specific dosage adjustments for geriatric patients are not provided, healthcare providers should exercise caution and closely monitor this population for any adverse effects or changes in efficacy. It is essential to evaluate the overall health status and comorbidities of elderly patients, as these factors may influence the safety and effectiveness of the treatment. Regular assessment and appropriate dose modifications may be necessary to ensure optimal therapeutic outcomes in this demographic.

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 no specific data available regarding the excretion of this medication in 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 may necessitate dosage adjustments based on their creatinine clearance levels. It is essential for healthcare professionals to monitor renal function regularly in these patients. Special consideration should be given to those with severe renal impairment, as they may require more careful management. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with liver problems, as their altered metabolic capacity may influence therapeutic outcomes.

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 lack of detailed data does not preclude the possibility of adverse effects. Symptoms of overdose can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management strategies tailored to the situation. Documentation of the incident and any interventions performed is crucial for ongoing patient care and future reference.

Overall, while specific overdosage information is not available, vigilance and prompt action are paramount in managing potential overdose scenarios effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available at this time.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Furthermore, patients should be advised to consult a doctor before using this product if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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 room temperature, ensuring that it is not refrigerated. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. Patients should not exceed 6 doses within a 24-hour period. Clinicians should advise patients to shake the product well before use and to measure the dosage using the provided dosing cup, which should be kept with the product. It is important to note that this formulation is not intended for use in children under 12 years of age. Additionally, the product should be stored at room temperature and not refrigerated.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Premier Value, 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 Premier Value, 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.