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Vicks Formula 44

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Active ingredients
  • Acetaminophen 650 mg/30 mL
  • Guaifenesin 400 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
  • Phenylephrine Hydrochloride 10 mg/30 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2020
Label revision date
October 2, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 650 mg/30 mL
  • Guaifenesin 400 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
  • Phenylephrine Hydrochloride 10 mg/30 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2020
Label revision date
October 2, 2025
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M012
NDC root
69423-964
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

VICKS® FORMULA 44™ DM VapoCOOL™ is a medication designed to temporarily relieve symptoms associated with the common cold and flu. It contains several active ingredients, including acetaminophen (a pain reliever and fever reducer), guaifenesin (which helps loosen mucus), phenylephrine HCl (a decongestant that reduces swelling in the nasal passages), and dextromethorphan HBr (a cough suppressant).

This product can help alleviate nasal and sinus congestion, pressure, cough due to throat irritation, minor aches and pains, headaches, fever, and sore throat. By promoting nasal and sinus drainage and loosening phlegm, it makes coughs more productive, allowing for easier breathing and relief from discomfort.

Uses

This medication is designed to temporarily relieve a variety of common cold and flu symptoms. If you're experiencing nasal congestion, sinus pressure, or a cough due to minor throat and bronchial irritation, this product can help. It also addresses minor aches and pains, headaches, fever, and sore throats.

In addition to alleviating these symptoms, it works to reduce swelling in the nasal passages, making it easier for you to breathe through your nose. It promotes drainage in your nasal and sinus areas and helps loosen phlegm (mucus) and thin bronchial secretions, which can make your coughs more productive by clearing out bothersome mucus.

Dosage and Administration

It's important to take your medication exactly as directed. Use only the dose cup that comes with the medication to ensure you measure the correct amount. For adults and children aged 12 years and older, the recommended dose is 30 mL every 4 hours, but remember not to exceed 4 doses in a 24-hour period.

If you're considering giving this medication to a child aged 4 to under 12 years, it's best to consult a doctor first. For children under 4 years old, this medication should not be used at all. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this medication if you are currently taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist for clarification. Additionally, do not use this medication if you are taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or if you have stopped taking an MAOI within the last two weeks. Again, if you're uncertain about your medications, it's best to ask a healthcare professional.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. You should avoid taking more than 4 doses in 24 hours, as exceeding this limit can cause severe liver damage, especially if you also consume alcohol or take other medications containing acetaminophen. Be cautious of potential severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If you experience any of these, stop using the product and seek medical help immediately.

If you have a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. Additionally, you should stop using the medication and contact a healthcare professional if you feel nervous, dizzy, or have trouble sleeping, if your pain or cough worsens or lasts more than a week, or if you develop new symptoms. It's also advisable to talk to your doctor before using this product if you have any pre-existing health conditions, such as liver disease, heart disease, or diabetes, or if you are taking blood thinners like warfarin.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4 doses in 24 hours, use it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as reddening, blisters, or rash. If you experience any skin reaction, stop using the product and seek medical help immediately. Additionally, if you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

To ensure your safety, do not use this product with any other medications containing acetaminophen, and avoid it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks. If you notice any of the following, stop using the product and contact your doctor: increased nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever lasting more than 3 days; redness or swelling; new symptoms; or a cough that returns with a rash or headache.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t wait—get help right away. Remember, acting quickly can make a significant difference in the outcome.

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

If you have a child aged 4 to under 12 years, it's important to consult with a doctor before using this medication. For children under 4 years old, you should not use this product at all.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, but be careful not to exceed 4 doses in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not take more than 4 doses in a 24-hour period, as this is the maximum daily amount. Additionally, be careful not to combine this product with other medications that also contain acetaminophen, as this can increase the risk of liver damage.

If you consume 3 or more alcoholic drinks each day, you should avoid using this product altogether, as alcohol can further strain your liver. Always consult with your healthcare provider for personalized advice and to ensure your safety while using any medication.

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 at a temperature no greater than 25°C (77°F). It's important not to refrigerate the product, as this could affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe and effective use.

Additional Information

You should take this medication orally, with adults and children aged 12 years and older typically taking 30 mL every 4 hours. If the patient is a child between 4 and 12 years old, consult a doctor for the appropriate dosage. This medication is not recommended for children under 4 years old.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Always keep it out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if no symptoms are present.

FAQ

What is VICKS® FORMULA 44™ DM VapoCOOL™ used for?

It temporarily relieves common cold and flu symptoms, including nasal congestion, sinus pressure, cough, minor aches, headache, fever, and sore throat.

What are the active ingredients in this product?

The active ingredients are Acetaminophen, Guaifenesin, Phenylephrine HCl, and Dextromethorphan HBr.

How should I take VICKS® FORMULA 44™ DM VapoCOOL™?

Adults and children 12 years and over should take 30 mL every 4 hours, not exceeding 4 doses in 24 hours. For children 4 to under 12 years, consult a doctor.

Are there any warnings I should be aware of?

Yes, do not use with other drugs containing acetaminophen, and avoid if you are taking a monoamine oxidase inhibitor (MAOI). Severe liver damage may occur if you exceed the recommended dosage.

What should I do if I experience a skin reaction?

If you notice symptoms like skin reddening, blisters, or rash, stop use immediately and seek medical help.

Can I use this product if I am pregnant or breastfeeding?

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

What should I do if my symptoms worsen or do not improve?

Stop use and consult a doctor if you experience worsening symptoms, new symptoms, or if your cough lasts more than 7 days.

How should I store VICKS® FORMULA 44™ DM VapoCOOL™?

Store at no greater than 25°C and do not refrigerate.

Packaging Info

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

Packaging configurations for Vicks Formula 44.
Details

Drug Information (PDF)

This file contains official product information for Vicks Formula 44, 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 temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, and sore throat. Additionally, it reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps loosen phlegm (mucus) and thin bronchial secretions, thereby facilitating the clearance of 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 take the medication only as directed. It is essential to utilize the dose cup provided to ensure accurate measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period.

For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease. This contraindication extends for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI before using this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to minimize the risk of liver injury:

  • Do not exceed 4 doses within a 24-hour period, as this is the maximum daily amount.

  • Avoid concurrent use with other medications containing acetaminophen.

  • Refrain from consuming 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, patients should be advised to consult a healthcare provider if the sore throat persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions include the following:

  • Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional.

  • This product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to stop taking the product and contact a healthcare provider if they experience any of the following:

  • Nervousness, dizziness, or sleeplessness

  • Worsening pain, nasal congestion, or cough lasting more than 7 days

  • Fever that worsens or lasts more than 3 days

  • Presence of redness or swelling

  • Onset of new symptoms

  • Recurrence of cough, particularly if accompanied by a rash or headache lasting longer than usual.

In the event of a skin reaction, patients must stop using the product and seek emergency medical help immediately.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of four doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

Prior to using this product, patients should consult a doctor if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, those with a cough that produces excessive phlegm, or persistent or chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice. Patients on a sodium-restricted diet should also consult a healthcare professional before use.

Furthermore, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to using this product.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Vicks Formula 44.
Details

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The medication is not recommended for children under 4 years of age. For adolescents and adults aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 4 doses within a 24-hour period to avoid the risk of severe liver damage.

Additionally, patients must avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of hepatotoxicity. Consumption of three or more alcoholic drinks per day while using this product is also contraindicated, as it may exacerbate liver damage.

Monitoring of liver function is recommended for patients with compromised liver function who are prescribed this product. Regular assessment of liver enzymes and overall liver health should be conducted to ensure patient safety and to mitigate the risk of adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important 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 within the last two weeks. Patients who are unsure if their prescription medication contains an MAOI should seek guidance from a healthcare professional.

Patients should be advised to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be instructed to stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms that arise should also prompt a consultation with a healthcare provider.

Patients should be made aware that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. When using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients on a sodium-restricted diet or those taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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. Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 4 hours for adults and children aged 12 years and older. For children aged 4 to under 12 years, it is advised to consult a doctor regarding appropriate dosing, while the medication should not be used in children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Vicks Formula 44, 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 44, 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.