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Vicks Formula 44dm

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Active ingredients
  • Guaifenesin 400 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2025
Label revision date
April 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2025
Label revision date
April 9, 2025
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M012
NDC root
84126-355
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

VICKS FORMULA 44DM HONEY COUGH & CONGESTION is a medication designed to help relieve symptoms associated with the common cold, such as cough and chest congestion. It contains two active ingredients: dextromethorphan HBr, which temporarily alleviates cough caused by minor throat and bronchial irritation, and guaifenesin, which helps loosen phlegm (mucus) and thin bronchial secretions. This action makes it easier for you to clear mucus from your airways, leading to more productive coughs.

This product is available in a 12 FL OZ (354 mL) bottle and is intended to provide relief from bothersome coughs and congestion, helping you feel more comfortable when you're under the weather.

Uses

If you're dealing with a common cold, this medication can help temporarily relieve your symptoms. It works by soothing coughs caused by minor irritation in your throat and bronchial tubes. Additionally, it helps loosen phlegm (a thick mucus) and thin out bronchial secretions, making it easier for you to clear out bothersome mucus and have more productive coughs. This can provide some comfort as your body fights off the cold.

Dosage and Administration

It's important to take this medication exactly as directed. You should only use the dose cup that comes with the medication to ensure you're measuring the correct amount. Remember, you should not exceed 6 doses in a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL every 4 hours. If your child is between 6 and under 12 years old, they should take 15 mL every 4 hours. For children aged 4 to under 6 years, it's best to consult a doctor before giving them this medication. Please do not use this medication for children under 4 years old.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, it's important to consult with your doctor or pharmacist before taking this product.

Taking this medication while on an MAOI can lead to serious health risks, so please prioritize your safety by following these guidelines closely.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is used for certain mental health conditions, or if you have stopped taking one within the last two weeks, you should not use this product.

If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, it’s important to stop using the medication and consult a doctor, as these could indicate a more serious health issue. Additionally, you should talk to your doctor before using this product if you have a cough with excessive mucus, a chronic cough from smoking or lung conditions, or if you are on a sodium-restricted diet.

Warnings and Precautions

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

If your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the product and contact your doctor immediately. These symptoms could indicate a more serious health issue that needs attention.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

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 it comes to using this medication for children, it's important to follow specific guidelines based on their age. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. If your child is between 4 and under 6 years old, you should consult a doctor before giving them this medication. For children under 4 years, it is advised not to use this medication at all.

Always ensure you are following these age-specific recommendations to keep your child safe and healthy. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for guidance.

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 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 ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease, you should not use 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, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns about your treatments.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature no greater than 25°C (77°F). This helps maintain its effectiveness and safety.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You should 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 VICKS FORMULA 44DM HONEY COUGH & CONGESTION?

It is a medication that contains Dextromethorphan HBr and Guaifenesin, designed to temporarily relieve common cold symptoms.

How does VICKS FORMULA 44DM work?

It temporarily relieves cough due to minor throat and bronchial irritation and helps loosen phlegm (mucus) to make coughs more productive.

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

Adults and children 12 years and over should take 30 mL every 4 hours.

Can children under 4 years use this medication?

No, it is not recommended for children under 4 years.

What should I do if my cough persists?

Stop use and ask a doctor if your cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache.

Are there any contraindications for using this medication?

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last 2 weeks.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using this medication.

How should I store VICKS FORMULA 44DM?

Store it at no greater than 25°C.

Packaging Info

Below are the non-prescription pack sizes of Vicks Formula 44dm (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vicks Formula 44dm.
Details

Drug Information (PDF)

This file contains official product information for Vicks Formula 44dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

VICKS® FORMULA 44DM HONEY COUGH & CONGESTION is a combination medication formulated to address cough and chest congestion. The active ingredients include Dextromethorphan HBr, which acts as a cough suppressant, and Guaifenesin, an expectorant that thins and loosens mucus. This product is available in a liquid dosage form, with a total volume of 12 fluid ounces (354 mL).

Uses and Indications

This drug is indicated for the temporary relief of common cold symptoms, including cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. The provided dose cup must be utilized for accurate measurement. It is imperative not to exceed a total of 6 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL administered every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 years, consultation with a healthcare professional is advised before administration. The product is not recommended for use in children under 4 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 they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the use of this product is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should advise patients to discontinue use and seek medical attention if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric or emotional conditions, or Parkinson's disease. The use of this product is contraindicated in patients currently taking an MAOI or within 2 weeks of discontinuing such medication.

Patients are advised to stop using the product and consult a healthcare professional if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Before using this product, patients should seek medical advice if they have a cough that produces excessive phlegm (mucus), a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if they are on a sodium-restricted diet.

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, psychiatric or emotional conditions, and 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 medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Vicks Formula 44dm (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vicks Formula 44dm.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before use. The product is not recommended for children under 4 years of age.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 the safety of both the mother and the developing fetus.

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 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 outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

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 and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, 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 to guide management decisions and ensure optimal patient care.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be encouraged to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to stop using the medication and seek medical advice if their cough persists for more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, as these symptoms may indicate a serious condition.

Additionally, healthcare providers should recommend that patients consult with a doctor before using this product if they have a cough that produces excessive phlegm, a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if they are on a sodium-restricted diet.

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 not exceeding 25°C to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance and safety.

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 Vicks Formula 44dm, 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 Vicks Formula 44dm, 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.