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Vicks Formula 44dm

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Active ingredients
  • Guaifenesin 200 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 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 2020
Label revision date
December 2, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 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 2020
Label revision date
December 2, 2025
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M012
NDC root
69423-810
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

VICKS ® FORMULA 44™ DM is a medication designed to help relieve cough and chest congestion. It contains two active ingredients: dextromethorphan HBr, which temporarily alleviates cough caused by minor throat and bronchial irritation associated with a cold, and guaifenesin, which helps loosen phlegm (mucus) and thin bronchial secretions. This action aids in clearing out bothersome mucus from the bronchial passageways.

This non-drowsy formula is available in a 12 FL OZ (354 ml) bottle and is specifically formulated to provide relief from the discomfort of cough and chest congestion, making it easier for you to breathe and feel more comfortable during a cold.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation from a cold, this medication can provide temporary relief. It works by helping to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for you to clear out bothersome mucus from your airways. This can help you breathe more comfortably while you recover.

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. Lastly, do not use this medication for children under 4 years old. 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 is a type of medication often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, you should not use this product for at least two weeks after stopping an MAOI. If you're 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 your health by seeking professional advice when in doubt.

Side Effects

You should avoid using this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's important to stop using this product and contact your doctor if your cough lasts more than a week, comes back frequently, or is accompanied by symptoms like fever, rash, or a persistent headache, as these could indicate a more serious health issue. Additionally, consult your doctor before using this medication if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, if your cough produces a lot of mucus, 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.

It's important to stop using this product and contact your doctor if your cough lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a persistent headache, as these could indicate a more serious health issue. Before using this product, you should also check with your doctor if you have a chronic cough from smoking, asthma, chronic bronchitis, or emphysema, if your cough produces a lot of mucus, or if you are on a sodium-restricted diet.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious when it comes to your health.

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 to ensure their safety. 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 prioritize your child's health by adhering to these age-specific recommendations and seeking professional advice when necessary.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 when taking certain medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), or if you have stopped taking one within the last two weeks, you should avoid using this medication. Taking these together can lead to serious interactions that may affect your health.

Always discuss any medications you are taking with your healthcare provider. They can help ensure that your treatments are safe and effective, and they can provide guidance on any potential interactions with other drugs or tests. Your safety is the top priority, so don't hesitate to ask questions about your medications.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature not exceeding 25°C (77°F). This helps maintain its effectiveness and integrity.

When handling the product, always do so with care to avoid any damage. Make sure to follow any specific instructions provided for use, and dispose of any components according to local regulations to ensure safety and environmental protection.

Additional Information

You will 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 44™ DM used for?

VICKS ® FORMULA 44™ DM is used to temporarily relieve cough due to minor throat and bronchial irritation associated with a cold and helps loosen phlegm (mucus).

What are the active ingredients in VICKS ® FORMULA 44™ DM?

The active ingredients are Dextromethorphan HBr and Guaifenesin.

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 VICKS ® FORMULA 44™ DM?

No, VICKS ® FORMULA 44™ DM should not be used in 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 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.

Are there any contraindications for using this product?

Do not use VICKS ® FORMULA 44™ DM if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using VICKS ® FORMULA 44™ DM.

How should VICKS ® FORMULA 44™ DM be stored?

Store VICKS ® FORMULA 44™ DM 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

No description information is available.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation associated with a cold. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways.

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 contraindicated 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 if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use of this product is contraindicated for a period of two 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 use.

In the event that a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, patients should discontinue use and seek medical advice. A persistent cough may indicate an underlying serious condition that requires further evaluation.

General precautions should be observed prior to use of this product. Patients are advised to consult a healthcare professional if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough that produces excessive phlegm (mucus) or those on a sodium-restricted diet should also seek medical guidance before using this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in such cases, and patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions may include a persistent cough. Patients are advised to stop use and seek medical attention if their cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, patients should consult a healthcare provider before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). Those on a sodium-restricted diet should also seek medical advice prior to use.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy, as this may result in serious interactions.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

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 a dosage of 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

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 therapeutic response, 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 on 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure optimal patient outcomes.

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

Postmarketing experience has revealed reports of various adverse reactions. These include allergic reactions, with some cases of anaphylaxis, as well as skin reactions such as rash, urticaria, and pruritus. These events have been reported voluntarily or identified through surveillance programs.

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 stopped taking an MAOI drug within the last two weeks. Patients who are uncertain whether their prescription medication contains an MAOI should be encouraged to consult with their doctor or pharmacist prior to using this product.

Patients should be instructed to discontinue use and seek medical advice if their cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should recommend that patients consult with a doctor before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, if they experience a cough that produces excessive phlegm (mucus), 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.

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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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.