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Acetaminophen/Dextromethorphan hydrobromide/Doxylamine succinate/Phenylephrine…

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Active ingredients
  • Doxylamine Succinate 6.25 mg/15 mL – 12.5 mg
  • Acetaminophen 325 mg/15 mL – 650 mg
  • Dextromethorphan Hydrobromide 10 mg/15 mL – 20 mg
  • Phenylephrine Hydrochloride 5 mg/15 mL – 10 mg
Reference brand
Night Cold Flu Cough and Allergy
Drug classes
Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage forms
  • Capsule
  • Capsule, Gelatin Coated
  • Capsule, Liquid Filled
  • Liquid
  • Powder, for Solution
  • Solution
  • Tablet, Coated
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
March 14, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredients
  • Doxylamine Succinate 6.25 mg/15 mL – 12.5 mg
  • Acetaminophen 325 mg/15 mL – 650 mg
  • Dextromethorphan Hydrobromide 10 mg/15 mL – 20 mg
  • Phenylephrine Hydrochloride 5 mg/15 mL – 10 mg
Reference brand
Night Cold Flu Cough and Allergy
Drug classes
Antihistamine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage forms
  • Capsule
  • Capsule, Gelatin Coated
  • Capsule, Liquid Filled
  • Liquid
  • Powder, for Solution
  • Solution
  • Tablet, Coated
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2013
Label revision date
March 14, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (105)
Product Labels (105)

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Drug Overview

Severe Cold and Flu is a medication designed to temporarily relieve symptoms associated with the common cold and flu. It contains a combination of active ingredients, including acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), doxylamine succinate (an antihistamine), and phenylephrine HCl (a nasal decongestant). This formulation helps alleviate nasal and sinus congestion, minor aches and pains, headaches, sore throats, runny noses, and sneezing, while also reducing fever and promoting better sleep by suppressing cough.

This medication is available in various forms, including liquid solutions and capsules, and is often marketed for nighttime use to provide relief while you rest. It is important to follow the recommended dosage to ensure safe and effective use.

Uses

You can use this medication to temporarily relieve a variety of common cold and flu symptoms. It helps with nasal congestion, sinus congestion and pressure, sore throat, headache, minor aches and pains, fever, runny nose, and sneezing. Additionally, it can alleviate cough caused by minor throat and bronchial irritation, making it easier for you to sleep.

This medication also works to reduce swelling of the nasal passages and promotes drainage of the nasal and sinus areas, which can help restore freer breathing through the nose. If you're feeling under the weather, this product can provide the relief you need to feel more comfortable.

Dosage and Administration

You should take this medication only as directed and use the dosing cup provided to measure your dose. For adults and children aged 12 years and older, the recommended dose is 30 mL every 4 hours, but do not exceed 4 doses in a 24-hour period. If you are giving this medication to children aged 6 to under 12 years, the dose is 15 mL every 4 hours. For children aged 4 to under 6 years, consult a doctor before use. Children under 4 years should not use this medication.

If you are using a powdered form, dissolve one packet in 8 oz. of hot water and sip while hot. Adults and children 12 years and older can take one packet every 4 hours, not exceeding 6 packets in a 24-hour period. Children under 12 years should not use this product. Always read the label carefully to ensure you are following the correct dosing instructions.

What to Avoid

You should avoid using this product if you are currently taking any other medication that contains acetaminophen (a common pain reliever) or if you are unsure whether a drug contains acetaminophen; consult a doctor or pharmacist for clarification. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) (medications for depression or certain psychiatric conditions) or if you have taken an MAOI within the last two weeks. If you have ever had an allergic reaction to this product or any of its ingredients, do not use it.

Furthermore, do not use this product to induce sleep in children, and be cautious about using it if you have a history of allergic reactions to similar medications. Always follow the recommended dosage and avoid consuming alcoholic beverages while using this product, as they may increase drowsiness. If you experience any adverse effects or if symptoms persist, seek medical advice promptly.

Side Effects

You should be aware of several potential side effects when using products containing acetaminophen for cold and flu relief. Severe liver damage can occur if you exceed 4,000 mg of acetaminophen in 24 hours, take it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using these products.

Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately. It's also important to consult a doctor if you have a sore throat that lasts more than two days, is severe, or is accompanied by fever, headache, rash, nausea, or vomiting.

You should stop using the product and consult a doctor if you experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 7 days, or if fever persists for more than 3 days. New symptoms or a cough that returns with a rash or headache could indicate a serious condition. Always follow the recommended dosage and be cautious when driving or operating machinery, as drowsiness may occur, especially when combined with alcohol or sedatives.

Warnings and Precautions

You should be aware of several important warnings and precautions when using products containing acetaminophen for cold and flu relief:

  • Liver Damage Risk: Taking more than 4,000 mg of acetaminophen in 24 hours can lead to severe liver damage. This risk increases if you consume three or more alcoholic drinks daily while using these products or if you take other medications containing acetaminophen. For children, taking more than the recommended doses can also be harmful.

  • Allergic Reactions: Acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately.

  • Sore Throat Warning: If you have a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • Consult Your Doctor: Before using these products, talk to your doctor if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or if you have trouble urinating due to an enlarged prostate. Also, consult your doctor if you are taking blood thinners like warfarin or sedatives.

  • When to Stop Use: Call your doctor if you experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; or if new symptoms develop. These could indicate a serious condition.

  • Emergency Help: In case of overdose, seek medical help or contact a Poison Control Center immediately (1-800-222-1222). Quick medical attention is crucial for both adults and children, even if no symptoms are present.

Overdose

If you suspect an overdose of cold and flu medications, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if you do not notice any signs or symptoms.

Taking more than the recommended dose can lead to severe liver damage, especially if you exceed 4,000 mg of acetaminophen in 24 hours, take multiple medications containing acetaminophen, or consume three or more alcoholic drinks daily while using these products. Symptoms of overdose may include severe skin reactions or liver issues, so it's important to stop using the medication and consult a healthcare professional if you experience any concerning symptoms.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any cold or flu medications. Many products, including various solutions, capsules, and liquids, carry a warning advising against use during pregnancy unless directed by a healthcare provider. This is due to potential risks to the fetus, which have not been fully established for these medications.

Always prioritize your health and the health of your baby by seeking professional guidance before taking any medication during pregnancy or while breastfeeding.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any medications, including those for cold and flu relief. This is because some ingredients may pass into breast milk, potentially affecting your infant. While specific warnings or recommendations for nursing mothers are not always provided, it's best to err on the side of caution and seek guidance from your doctor or pharmacist.

Pediatric Use

When considering cold and flu medications for your child, it's important to follow specific guidelines based on their age. For children aged 6 to under 12 years, the typical dosage is 15 mL every 4 hours, but do not exceed 4 doses in 24 hours. For children aged 4 to under 6 years, you should consult a doctor before use, and for those under 4 years, these medications should not be used at all.

Be aware that excitability may occur, especially in children, and marked drowsiness can also happen. If your child's symptoms worsen or last more than 5 days, consult a doctor. In case of an overdose, seek medical help immediately, as quick attention is crucial for both children and adults, even if no symptoms are apparent. Always keep medications out of reach of children.

Geriatric Use

When considering nighttime cold and flu medications, it's important to be aware that specific dosage adjustments or safety concerns for elderly patients are often not detailed in the product inserts. However, caution is advised for older adults, especially those with underlying health conditions such as liver disease, heart disease, high blood pressure, diabetes, glaucoma, or prostate issues.

Many of these medications can cause marked drowsiness, which may be more pronounced in older individuals. Therefore, it is recommended to consult with a healthcare provider before use, particularly if you are taking other sedatives or tranquilizers, as these can increase drowsiness. Additionally, avoid alcohol, as it may exacerbate these effects. Always prioritize safety and seek guidance tailored to your health needs.

Renal Impairment

When using medications for cold and flu, it's important to be aware of how kidney health can affect your treatment. If you have renal impairment, you may need to adjust your dosage based on your kidney function, specifically your creatinine clearance levels. Regular monitoring of your renal function is also recommended to ensure safety.

For some products, such as certain nighttime cold and flu solutions, it's advised to consult a doctor if you experience difficulty urinating, especially if related to an enlarged prostate gland. Always prioritize discussing your kidney health with a healthcare professional before starting any new medication.

Hepatic Impairment

You should be aware that many cold and flu medications contain acetaminophen, which can lead to severe liver damage if not used properly. To avoid this risk, do not exceed 4,000 mg of acetaminophen in a 24-hour period, and be cautious if you are taking other medications that also contain acetaminophen or if you consume three or more alcoholic drinks daily while using these products.

If you have liver disease, it is essential to consult a doctor before using any of these medications. Always follow the recommended dosage instructions, as taking more than the advised amount can result in serious health issues. If you suspect an overdose, seek medical help immediately, even if you do not show any symptoms.

Drug Interactions

When using nighttime cold and flu medications, it's crucial to be aware of potential interactions with other drugs. Avoid taking any product containing acetaminophen alongside other acetaminophen-containing medications, as this can significantly increase the risk of severe liver damage. If you consume three or more alcoholic drinks daily, this risk is further heightened. Additionally, if you are taking a monoamine oxidase inhibitor (MAOI) for depression or other conditions, do not use these medications during treatment or for two weeks after stopping, as serious side effects may occur.

If you are on blood thinners like warfarin, consult your doctor or pharmacist before using these products, as acetaminophen can alter its effects, necessitating close monitoring of your INR levels (a measure of blood clotting). Lastly, be cautious with alcohol, sedatives, and tranquilizers, as they can increase drowsiness when combined with these medications. Always discuss your current medications and health conditions with your healthcare provider to ensure safe use.

Storage and Handling

To ensure the effectiveness of your cold and flu medication, store it at room temperature between 20-25°C (68-77°F). Avoid refrigeration, as it can affect the product's quality. If your medication specifies a maximum temperature of 25°C (77°F), be mindful not to exceed this limit. Protect the product from light, heat, and moisture by keeping it in a tightly closed container.

When disposing of any unused medication, follow local guidelines for safe disposal. If the packaging is damaged or if the product has passed its expiration date, do not use it. Always keep medications out of reach of children to ensure safety.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including:

  • Nasal congestion

  • Sinus congestion and pressure

  • Minor aches and pains

  • Headache

  • Fever

  • Sore throat

  • Runny nose and sneezing

  • Cough due to minor throat and bronchial irritation

  • Cough to help you sleep

  • Reduces swelling of nasal passages

  • Promotes nasal and/or sinus drainage

  • Temporarily restores freer breathing through the nose

Limitations of Use This drug does not have any stated teratogenic or nonteratogenic effects.

Dosage and Administration

Adults and children 12 years and older are recommended to take 30 mL of the solution every 4 hours, not to exceed 4 doses in a 24-hour period. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours, with a maximum of 4 doses in 24 hours. Children aged 4 to under 6 years should only be given the medication if directed by a doctor. It is advised that children under 4 years of age do not use this product.

For capsule forms, adults and children 12 years and older should take 2 softgels with water every 4 hours, not exceeding 8 softgels in a 24-hour period. Children under 12 years should consult a doctor before use.

When using any liquid formulation, it is essential to measure the dosage using the provided dosing cup, as other devices may lead to incorrect dosing. Additionally, users should be aware of the overdose warning and adhere strictly to the recommended dosages.

Contraindications

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If unsure whether a drug contains acetaminophen, consult a doctor or pharmacist.

Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If uncertain whether a prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

Do not use if there has been a previous allergic reaction to this product or any of its ingredients.

Do not use to make a child sleepy.

Do not use in children under 12 years of age.

Avoid alcoholic drinks while using this product.

Do not exceed the recommended dosage.

Warnings and Precautions

Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take:

  • More than 4,000 mg of acetaminophen in 24 hours.

  • With other drugs containing acetaminophen.

  • 3 or more alcoholic drinks every day while using this product.

Allergy Alert Acetaminophen may cause severe skin reactions. Symptoms may include:

  • Skin reddening

  • Blisters

  • Rash If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

General Precautions Ask a doctor before use if you have:

  • Liver disease

  • Heart disease

  • High blood pressure

  • Glaucoma

  • Thyroid disease

  • Diabetes

  • Cough that occurs with too much phlegm (mucus)

  • A breathing problem such as emphysema or chronic bronchitis

  • Trouble urinating due to an enlarged prostate gland

  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • A sodium-restricted diet

Ask a doctor or pharmacist before use if you are:

  • Taking sedatives or tranquilizers

  • Taking the blood thinning drug warfarin

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • To make a child sleepy.

Get Emergency Medical Help In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Stop Taking and Call Your Doctor If

  • You get nervous, dizzy, or sleepless.

  • Pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults).

  • Fever gets worse or lasts more than 3 days.

  • Redness or swelling is present.

  • New symptoms occur.

  • Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Side Effects

Severe liver damage may occur if patients take more than 4,000 mg of acetaminophen in 24 hours, with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using these products.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients should stop use and seek medical help immediately.

Serious Adverse Reactions

  • Liver Damage: Risk increases with:

    • Dosage exceeding 4,000 mg in 24 hours.

    • Concurrent use with other acetaminophen-containing medications.

    • Consumption of 3 or more alcoholic drinks daily.

  • Severe Skin Reactions: Symptoms may include:

    • Skin reddening

    • Blisters

    • Rash

Common Adverse Reactions

  • Nervousness, Dizziness, or Sleeplessness: Patients should stop use and consult a doctor if these symptoms occur.

  • Worsening Symptoms: Patients should seek medical advice if pain, nasal congestion, or cough worsens or lasts more than 7 days (5 days for children), or if fever worsens or lasts more than 3 days.

  • New Symptoms: The emergence of new symptoms or a cough that returns or occurs with a rash or headache lasting could indicate a serious condition.

Additional Considerations

  • Marked Drowsiness: Patients may experience significant drowsiness, particularly when using the product in conjunction with alcohol, sedatives, or tranquilizers.

  • Excitability: This may occur, especially in children.

  • Driving and Machinery: Caution is advised when operating vehicles or machinery due to potential drowsiness.

Overdose Warning

In case of overdose, patients should seek immediate medical help or contact a Poison Control Center. Quick medical attention is critical for both adults and children, even if no symptoms are present.

Consultation Recommendations

Patients should consult a doctor before use if they have:

  • Liver disease

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • Glaucoma

  • A cough that occurs with excessive phlegm (mucus)

  • A breathing problem such as emphysema or chronic bronchitis

  • Trouble urinating due to an enlarged prostate gland

  • Persistent or chronic cough as occurs with smoking, asthma, or emphysema

Patients should also consult a doctor or pharmacist before use if they are taking sedatives, tranquilizers, or the blood-thinning drug warfarin.

Drug Interactions

Acetaminophen, a common ingredient in many cold and flu medications, poses a significant risk of liver damage when taken in conjunction with other products containing acetaminophen or when consumed with three or more alcoholic drinks daily. This risk is emphasized across multiple formulations, including Vicks Nyquil, Alka-Seltzer Plus, and various nighttime cold and flu remedies.

Dextromethorphan, another active ingredient, may interact adversely with monoamine oxidase inhibitors (MAOIs), which are used for treating depression and other psychiatric conditions. It is crucial to avoid using dextromethorphan while on MAOIs or within two weeks of discontinuing them, as serious side effects may occur.

The anticoagulant effects of warfarin, a blood thinner, can be altered when taken with acetaminophen. Monitoring of International Normalized Ratio (INR) levels is advised for patients using both medications to ensure safe and effective anticoagulation. This interaction is noted in several products, including Vicks Nyquil and Alka-Seltzer Plus formulations.

Additionally, the combination of alcohol, sedatives, and tranquilizers with these medications may enhance drowsiness, necessitating caution in activities requiring alertness, such as driving or operating machinery. Users are advised to consult healthcare professionals if they are taking sedatives, tranquilizers, or warfarin before using these products.

In summary, careful consideration of potential drug interactions is essential when using medications containing acetaminophen, dextromethorphan, and other active ingredients, particularly in patients with existing conditions or those on concurrent therapies.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 15 mL every 4 hours for certain products, while those aged 4 to under 6 years should only use these products if directed by a doctor. For children under 4 years, these products are contraindicated.

Efficacy and Safety:

  • Excitability may occur, especially in children.

  • Marked drowsiness may also occur.

  • Parents and caregivers should monitor for worsening symptoms such as pain, nasal congestion, or cough lasting more than 5 days, and consult a doctor if these symptoms arise.

Dosing Guidelines:

  • For children aged 6 to under 12 years: 15 mL every 4 hours, not to exceed 4 doses in 24 hours.

  • For children aged 4 to under 6 years: Consult a doctor before use.

  • For children under 4 years: Do not use.

Overdose Warning:In case of overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are present. Caregivers should contact a Poison Control Center right away.

Cautions:

  • Keep out of reach of children.

  • Products should not be used to sedate children.

  • Liver damage may occur if a child takes more than 5 doses in 24 hours.

Geriatric Use

No specific information regarding dosage adjustments, safety concerns, or special precautions for elderly patients is provided across the various product inserts. However, general considerations suggest that caution should be exercised when administering these medications to geriatric patients, particularly those with underlying health conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or urinary issues related to an enlarged prostate gland.

Marked drowsiness may occur with these products, which could pose a risk for elderly patients who may be more sensitive to sedative effects. It is advisable for elderly patients to consult a healthcare professional before use, especially if they are taking sedatives, tranquilizers, or consuming alcohol, as these factors may exacerbate drowsiness and impair their ability to operate machinery or drive safely.

Overall, while no specific geriatric use data is available, healthcare providers should remain vigilant and consider individual patient factors when prescribing these medications to elderly patients.

Pregnancy

Pregnant patients should exercise caution when considering the use of cold and flu medications. It is recommended that they consult a healthcare professional before using any of these products, as safety during pregnancy has not been established for many formulations.

There may be potential risks to the fetus associated with the use of these products during pregnancy. Specifically, some formulations are contraindicated in pregnancy, and healthcare providers may suggest dosage modifications if necessary. Pregnant patients are advised to avoid using these products unless directed by a healthcare professional.

In summary, the use of cold and flu medications during pregnancy requires careful consideration and professional guidance to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products listed, as there is no specific information regarding the excretion of these medications in breast milk or their potential effects on breastfed infants. The available data indicates a general recommendation for nursing mothers to seek professional guidance prior to use, but no specific warnings or recommendations are provided for the majority of these products.

Given the lack of detailed information on the safety and potential risks associated with these medications during lactation, healthcare providers should carefully evaluate the necessity of treatment against any potential risks to the infant. It is essential for lactating mothers to prioritize both their health and the well-being of their breastfed infants when considering the use of these products.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain cold and flu medications. Specifically, it has been noted that renal impairment may necessitate dosage adjustments, and regular monitoring of renal function is advised.

For some products, dosage adjustments should be based on creatinine clearance levels, particularly for those with severe renal impairment. It is essential for healthcare providers to evaluate renal function tests in patients with kidney problems to determine the appropriate dosing regimen.

Additionally, caution is advised for patients experiencing difficulty in urination, especially those with an enlarged prostate gland, as this may complicate the use of these medications. In summary, while some products lack specific guidance on renal impairment, it is prudent for healthcare professionals to assess renal function and consider potential adjustments or monitoring requirements for patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using products containing acetaminophen. Severe liver damage may occur if the following conditions are met:

  • An adult takes more than 4,000 mg of acetaminophen in 24 hours.

  • An adult consumes 3 or more alcoholic drinks daily while using these products.

  • Acetaminophen is taken in conjunction with other medications containing acetaminophen.

It is recommended that patients with liver disease consult a healthcare professional before using any of these products. Specific dosage adjustments or monitoring requirements are not universally provided across all products; however, the general recommendation is to avoid exceeding the maximum daily dosage, which varies by product.

In cases of overdose, immediate medical attention is critical, even if no symptoms are present. Patients should be advised to contact a Poison Control Center or seek medical help promptly if an overdose is suspected.

Overdosage

In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially observed.

Symptoms of overdose may include severe liver damage, particularly if the individual consumes more than 4,000 mg of acetaminophen within a 24-hour period, takes the product in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using the product. It is essential to monitor for any signs of severe skin reactions or liver issues, which may indicate an overdose or severe allergic reaction.

If an overdose is suspected, individuals should stop using the product and seek emergency medical help immediately. Taking more than the recommended dose can lead to serious health complications, and prompt intervention is necessary to mitigate potential risks.

Nonclinical Toxicology

Teratogenic Effects

Several products indicate that individuals who are pregnant or breastfeeding should consult a health professional before use. However, specific teratogenic effects have not been provided in the available data for most products.

Non-Teratogenic Effects

No specific non-teratogenic effects have been mentioned across the reviewed products.

Nonclinical Toxicology

The available data does not provide specific details regarding nonclinical toxicology for any of the products reviewed.

Animal Pharmacology and Toxicology

No information regarding animal pharmacology and toxicology has been provided in the reviewed product inserts.

Storage and Handling

Products are supplied in various forms, including solutions, liquids, capsules, and tablets. The storage conditions for these products generally require maintaining a temperature range of 20-25°C (68-77°F). Some products may allow for excursions between 15-30°C (59-86°F), while others must not exceed 25°C (77°F) and should not be refrigerated.

Storage Conditions

  • Room Temperature: Many products should be stored at room temperature, specifically between 20-25°C (68-77°F).

  • Maximum Temperature: Certain products must not exceed 25°C (77°F) and should be protected from excessive heat.

  • Excursions: A few products permit temperature excursions between 15-30°C (59-86°F).

Handling Requirements

  • Refrigeration: Most products should not be refrigerated.

  • Protection from Light and Moisture: Products in capsule or liquid-filled forms should be protected from light, heat, and moisture to maintain their efficacy.

  • Tamper Evident: Some products have tamper-evident packaging; do not use if the outer package is opened or if the blister is torn or broken.

  • Expiration Date: Users should refer to the expiration date on the package and discard any product after opening if indicated.

These guidelines ensure the integrity and effectiveness of the products throughout their shelf life.

Product Labels

The table below lists all over-the-counter labels containing acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
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Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 105 FDA Structured Product Labels (DailyMed) for Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl (marketed as Severe Cold and Flu, Vicks Nyquil Severe Honey Flavor, Cold and Flu Nighttime Severe, 24-7 Life), with data retrieved by a validated AI data-extraction workflow. This includes 105 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.