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Phenylephrine hydrochloride/Dextromethorphan hydrobromide/Acetaminophen

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Active ingredients
  • Doxylamine Succinate 12.5 mg/30 mL – 6.25 mg
  • Acetaminophen 650 mg/30 mL – 325 mg
  • Dextromethorphan Hydrobromide 30 mg/30 mL – 15 mg
  • Phenylephrine Hydrochloride 5 mg
Dosage forms
  • Capsule
  • Capsule, Liquid Filled
  • Solution
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
January 26, 2026
Active ingredients
  • Doxylamine Succinate 12.5 mg/30 mL – 6.25 mg
  • Acetaminophen 650 mg/30 mL – 325 mg
  • Dextromethorphan Hydrobromide 30 mg/30 mL – 15 mg
  • Phenylephrine Hydrochloride 5 mg
Dosage forms
  • Capsule
  • Capsule, Liquid Filled
  • Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
January 26, 2026

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Drug Overview

This medication is designed to temporarily relieve symptoms associated with the common cold and flu. It helps alleviate minor aches and pains, headaches, sore throats, coughs, and nasal and sinus congestion. Additionally, it can reduce fever, making it a useful option for managing multiple cold and flu symptoms throughout the day and night.

The formulation typically includes active ingredients such as acetaminophen, which acts as a pain reliever and fever reducer; dextromethorphan, a cough suppressant; and phenylephrine or doxylamine, which serve as nasal decongestants and antihistamines, respectively. This combination allows you to find relief from discomfort during both daytime and nighttime, ensuring you can rest and recover effectively.

Uses

You can use this medication to temporarily relieve various symptoms associated with the common cold or flu. These symptoms include minor aches and pains, headaches, sore throats, nasal and sinus congestion, coughs, and fever. Additionally, some formulations may help clear nasal passages and reduce swollen membranes.

For daytime relief, the medication can alleviate nasal congestion and cough due to minor throat and bronchial irritation. At night, it may also help with runny noses and sneezing. Overall, this medication is designed to help you feel more comfortable while you recover from cold or flu symptoms.

Dosage and Administration

You should take the cold and flu medication as follows: For adults and children aged 12 years and older, take 2 softgels with water every 4 hours during the day, but do not exceed 10 softgels in 24 hours. At night, take 2 softgels with water every 6 hours, and again, do not exceed 10 softgels in 24 hours.

If you are using both daytime and nighttime products, do not take them at the same time. Wait at least 4 hours after your last nighttime dose before starting the daytime product. Children under 12 years should not use this medication, and if you have children aged 4 to under 12, consult a doctor for appropriate dosing. Always follow the instructions on the label and do not exceed the recommended doses.

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 taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for two weeks after stopping an MAOI. Additionally, do not use this product if you have ever had an allergic reaction to it or any of its ingredients, or if you are under 12 years of age.

When using this product, do not exceed the recommended dosage. For nighttime formulations, avoid alcoholic drinks, as they may increase drowsiness, especially when combined with sedatives or tranquilizers.

Side Effects

Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using these products. Symptoms of severe liver damage can include nausea, vomiting, and abdominal pain.

You should be aware that acetaminophen can also cause severe skin reactions, which may present as skin reddening, blisters, rashes, or hives. If you experience any of these symptoms, stop using the product and seek medical help immediately. Additionally, 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 promptly.

It's important to stop using the product and contact a healthcare professional if you experience worsening pain, cough, or nasal congestion lasting more than seven days, fever lasting more than three days, or if new symptoms develop. Nervousness, dizziness, or sleeplessness may also occur, particularly with nighttime formulations.

Warnings and Precautions

  • This product contains acetaminophen, which can cause severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it.

  • Be aware of severe skin reactions, which may include symptoms like skin reddening, blisters, rash, or hives. 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • Stop using the product and call your doctor if you experience worsening pain, cough, or nasal congestion lasting more than 7 days, fever lasting more than 3 days, redness or swelling, new symptoms, or if a cough returns with a rash or headache. These could indicate a serious condition.

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

Overdose

Taking too much acetaminophen, a common pain reliever found in many cold and flu medications, can lead to severe liver damage. You should not exceed 4,000 mg of acetaminophen in a 24-hour period, and be cautious if you are taking multiple products that contain acetaminophen or if you consume three or more alcoholic drinks daily while using these medications.

If you suspect an overdose, 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 of an overdose. Signs of overdose may include nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). Always follow the dosing instructions on the label to avoid serious health problems.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any cold and flu medications. This includes various formulations such as capsules and liquid-filled options, which may contain ingredients that could affect you or your baby. Always prioritize your health and safety by seeking professional advice tailored to your specific situation.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any medications, including cold and flu remedies. This is because certain ingredients in these products may pass into breast milk, potentially affecting your baby. Always prioritize your health and your baby's safety by seeking professional advice.

Pediatric Use

You should be aware that many cold and flu medications are not suitable for children under 12 years of age. For those 12 years and older, the typical dosage is 2 capsules or softgels every 4 to 6 hours, depending on the specific product, but you should not exceed 10 in a 24-hour period unless directed by a doctor.

For children aged 4 to under 12 years, it's important to consult a doctor before using any medication. Children under 4 years should not use these products at all. Be cautious, as some medications may cause excitability in children, and quick medical attention is necessary in case of an overdose, even if no symptoms are present. Always keep medications out of reach of children.

Geriatric Use

When considering cold and flu medications, it's important to be cautious, especially if you are an older adult or caring for one. Always consult a doctor before using products like Alka-Seltzer Plus or Axim if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. These medications may cause drowsiness, so avoid alcohol and be careful when driving or operating machinery.

For adults aged 12 and older, the general dosage is 2 capsules every 4 hours, not exceeding 10 capsules in 24 hours. Always adhere to the recommended dosage and seek medical attention if symptoms worsen or persist beyond a few days. If you are taking blood thinners like warfarin or other sedatives, consult your healthcare provider before use.

Renal Impairment

When considering cold and flu medications, it's important to note that the available information from various product labels does not specify any dosage adjustments, monitoring requirements, or safety warnings for individuals with kidney problems. This means that, as of now, there are no particular concerns or recommendations regarding the use of these medications for those with renal impairment.

If you have kidney issues, it's always a good idea to consult with your healthcare provider before starting any new medication, even if specific warnings are not listed. They can provide personalized advice based on your health needs.

Hepatic Impairment

When using products that contain acetaminophen, it's important to be aware of the potential risks to your liver. Severe liver damage can occur if you take more than 4,000 mg of acetaminophen in a 24-hour period, take it with other medications that also contain acetaminophen, or consume 3 or more alcoholic drinks daily while using these products.

If you have liver disease, please consult your doctor before using these medications. Always follow the recommended dosage and avoid alcohol to minimize risks. If your symptoms worsen or new symptoms arise, seek medical advice promptly.

Drug Interactions

When using products like Alka-Seltzer Plus or other cold and flu medications, it's important to be aware of potential interactions with other drugs. If you are taking warfarin, a blood thinner, consult your doctor or pharmacist before using these products, as they may increase the risk of bleeding or alter the effects of warfarin. Additionally, medications containing acetaminophen can lead to liver damage if taken with other acetaminophen-containing products or if you consume three or more alcoholic drinks daily.

Be cautious if you are taking monoamine oxidase inhibitors (MAOIs), as combining them with certain ingredients in these cold medications can lead to serious side effects. Always discuss your current medications and any tests with your healthcare provider to ensure your safety and the effectiveness of your treatments.

Storage and Handling

To ensure the effectiveness of your cold and flu medication, store it at room temperature, ideally between 20-25°C (68-77°F). Avoid exposing the product to excessive heat, particularly temperatures above 40°C (104°F), as this can compromise its quality.

When handling the capsules or liquid-filled forms, make sure to keep them in a cool, dry place, away from direct sunlight and moisture. If the packaging is tampered with or damaged, do not use the product. For disposal, follow local guidelines for medication disposal to ensure safety and environmental protection.

FAQ

What symptoms does this drug temporarily relieve?

This drug temporarily relieves common cold and flu symptoms, including fever, headache, minor aches and pains, cough due to minor throat and bronchial irritation, sore throat, nasal congestion (daytime only), and runny nose and sneezing (nighttime only).

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

Adults and children 12 years and over should take 2 softgels with water every 4 hours, not exceeding 4 doses in 24 hours.

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

For nighttime, adults and children 12 years and over should take 2 softgels with water every 6 hours, also not exceeding 4 doses in 24 hours.

Can children under 12 years use this drug?

No, this drug should not be used in children under 12 years of age.

What should I do if I experience severe skin reactions?

If you experience severe skin reactions such as reddening, blisters, or rash, stop use and seek medical help immediately.

Are there any contraindications for using this drug?

Do not use this drug with any other product containing acetaminophen, if you are taking a monoamine oxidase inhibitor (MAOI), or if you have had an allergic reaction to this product.

What are the liver warnings associated with this drug?

Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do if my symptoms worsen or persist?

If your pain, nasal congestion, or cough worsens or lasts more than 7 days, or if your fever lasts more than 3 days, stop use and consult a doctor.

Is it safe to use this drug during pregnancy or breastfeeding?

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

What should I do in case of overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

Uses and Indications

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

  • Minor aches and pains

  • Headache

  • Cough due to minor throat and bronchial irritation

  • Sore throat

  • Nasal congestion

  • Sinus congestion and pressure

  • Runny nose and sneezing

  • Fever

The formulation is available in both daytime and nighttime versions. The daytime formula is designed to relieve symptoms such as nasal congestion, while the nighttime formula may include additional components such as a cough suppressant, antihistamine, and nasal decongestant to aid in sleep.

Limitations of Use There are no teratogenic or nonteratogenic effects mentioned for this drug.

Dosage and Administration

Adults and children 12 years and over are instructed to take 2 softgels with water every 4 hours for daytime relief and every 6 hours for nighttime relief. The maximum dosage should not exceed 10 softgels in a 24-hour period or as directed by a healthcare professional. It is essential to avoid taking the daytime and nighttime products simultaneously; a minimum of 4 hours should elapse after the last nighttime dose before starting the daytime product.

Children under 12 years should not use this medication. For children aged 4 to under 12 years, consultation with a healthcare provider is recommended before use. Children under 4 years of age should not use this product.

When administering the medication, it is important to take only as directed and to adhere to the overdose warnings provided. Care should be taken to read the labels of any other daytime and nighttime products being used to ensure correct dosing.

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 in children under 12 years of age.

For nighttime formulations, do not use to make a child sleepy.

When using this product, do not exceed the recommended dosage. Avoid alcoholic drinks when using nighttime formulations, as alcohol, sedatives, and tranquilizers may increase drowsiness.

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

  • Hives

  • Facial swelling

  • Asthma (wheezing)

  • Shock If a skin or general allergic 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

  • Do not use with any other drug containing acetaminophen (prescription or nonprescription).

  • Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

  • Do not use in children under 12 years of age.

  • Ask a doctor before use if you have:

    • Liver disease

    • Heart disease

    • High blood pressure

    • Thyroid disease

    • Diabetes

    • Cough with excessive phlegm (mucus)

    • Difficulty in urination due to enlargement of the prostate gland

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

  • Ask a doctor or pharmacist before use if you are taking the blood-thinning drug warfarin.

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 Stop use and ask a doctor if:

  • Pain, cough, or nasal congestion gets worse or lasts more than 7 days.

  • 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.

  • Nervousness, dizziness, or sleeplessness occurs.

Side Effects

Severe liver damage may occur if patients exceed the following limits while using products containing acetaminophen:

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

  • Concurrent use with other drugs containing acetaminophen.

  • Consumption of 3 or more alcoholic drinks daily.

Patients should be aware of the following serious allergic reactions associated with acetaminophen, which may include:

  • Skin reddening

  • Blisters

  • Rash

  • Hives

  • Facial swelling

  • Asthma (wheezing)

  • Shock

If any of these symptoms occur, patients should stop use and seek medical help immediately.

Sore Throat Warning

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, should consult a doctor promptly.

Additional Adverse Reactions

Patients should discontinue use and consult a doctor if they experience:

  • Pain, cough, or nasal congestion that worsens or lasts more than 7 days.

  • Fever that worsens or lasts more than 3 days.

  • Redness or swelling at the site of symptoms.

  • New symptoms that develop.

  • Cough that returns or occurs with a rash or headache that lasts.

  • Nervousness, dizziness, or sleeplessness.

Special Populations

Patients should consult a doctor before use if they have:

  • Liver disease

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • Cough with excessive phlegm (mucus)

  • Difficulty urinating due to enlargement of the prostate gland

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

Drug Interactions

Patients taking blood-thinning medications, such as warfarin, should consult a doctor or pharmacist before use.

Overdose Warning

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

Drug Interactions

Patients should be aware of potential drug interactions when using products containing acetaminophen, dextromethorphan, and doxylamine.

Acetaminophen Interactions

  • Acetaminophen may interact with the blood thinner warfarin, potentially increasing the risk of bleeding. Patients taking warfarin are advised to consult a doctor or pharmacist before using products containing acetaminophen.

  • The risk of liver damage may increase when acetaminophen is taken with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily. This risk is particularly significant for products that contain high doses of acetaminophen.

  • Acetaminophen is contraindicated for use with prescription monoamine oxidase inhibitors (MAOIs) and for two weeks after discontinuation of MAOIs.

Dextromethorphan Interactions

  • Dextromethorphan may interact with MAOIs, leading to serious side effects. It is recommended to avoid using dextromethorphan if currently taking MAOIs or within two weeks of stopping them.

Doxylamine Interactions

  • Doxylamine may enhance drowsiness when taken with alcohol, sedatives, or tranquilizers. Caution is advised when combining these substances.

Monitoring Recommendations

  • Patients taking warfarin should closely monitor their INR levels when using products containing acetaminophen or dextromethorphan, as these substances may alter the effects of warfarin.

Overall, it is essential for patients to consult healthcare professionals before using these products, especially if they are on anticoagulant therapy or other medications that may interact.

Pediatric Use

Pediatric patients under 12 years of age should not use the following medications: Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu, Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night, Equate Health Non Drowsy Day Cold and Flu Plus and Nighttime Cold and Flu Plus, and Axim Daytime - Night Time.

For Goodnow Cold and Flu Day Relief and Cold and Flu Night Relief, the following dosing guidelines apply:

  • Children 4 to under 12 years: Consult a doctor before use.

  • Children under 4 years: Do not use.

  • Daytime Cold & Flu:

    • Children 6 to under 12 years: 15 mL every 4 hours.

    • Children 4 to under 6 years: Consult a doctor before use.

  • Nighttime Cold & Flu:

    • Adults & children 12 years & over: 30 mL every 6 hours.

Caution is advised as excitability may occur, especially in children. In cases of overdose, quick medical attention is critical for children, even if no signs or symptoms are noticed.

Geriatric Use

Elderly patients should exercise caution when using cold and flu medications, particularly those containing ingredients that may exacerbate existing health conditions. It is advisable for geriatric patients to consult a healthcare provider before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate.

While specific dosage adjustments for elderly patients are not universally provided, the general recommendation is to adhere strictly to the labeled dosage instructions. For instance, the recommended dosage for adults and children aged 12 years and older is typically 2 capsules every 4 hours, not exceeding 10 capsules in 24 hours.

Elderly patients may be more susceptible to side effects such as marked drowsiness, which can be intensified by the consumption of alcohol, sedatives, or tranquilizers. Caution is advised when driving or operating machinery due to the potential for increased drowsiness.

Quick medical attention is critical for elderly patients, even in the absence of noticeable signs or symptoms, particularly if symptoms worsen or persist beyond the recommended duration.

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 the products listed, including those in capsule or liquid-filled forms. The available data consistently advises that if a patient is pregnant or breastfeeding, they should seek professional guidance prior to use.

Currently, there is no specific risk category or detailed study results provided regarding the fetal impacts of these medications. Therefore, healthcare providers should weigh the potential benefits against any unknown risks when advising pregnant patients.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products listed, including Alka-Seltzer Plus Maximum Strength formulations, Equate Health Non Drowsy Cold and Flu, Goodnow Cold and Flu, and Axim Daytime - Night Time softgels.

There is no specific data provided regarding the excretion of these products in breast milk or their effects on breastfed infants. Therefore, caution is recommended, and healthcare guidance should be sought to ensure the safety of both the mother and the infant during lactation.

Renal Impairment

Patients with renal impairment may not have specific dosing adjustments, monitoring requirements, or safety considerations outlined in the available drug inserts for the various cold and flu formulations reviewed. The provided labels, including those for products such as Daytime Nighttime Cold and Flu, Alka-Seltzer Plus, and Equate Health Non Drowsy formulas, do not contain information regarding the impact of reduced kidney function on the pharmacokinetics or safety of these medications.

As there is a lack of guidance on the use of these products in patients with renal impairment, healthcare professionals should exercise caution when prescribing these medications to this patient population. It is advisable to consider alternative treatments or consult with a specialist when managing cold and flu symptoms in patients with compromised renal function, given the absence of specific recommendations in the product labeling.

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:

  • The maximum daily dosage of acetaminophen exceeds 4,000 mg within 24 hours.

  • Acetaminophen is taken concurrently with other medications containing acetaminophen.

  • The patient consumes three or more alcoholic drinks daily while using these products.

It is advised that patients with liver disease consult a healthcare professional before using these products. During use, patients should adhere strictly to the recommended dosage and avoid alcohol consumption.

Patients should discontinue use and seek medical advice if symptoms such as pain, cough, or nasal congestion worsen or persist beyond 7 days, if fever worsens or lasts more than 3 days, or if new symptoms arise. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, medical consultation is recommended.

Monitoring of liver function may be warranted in patients with pre-existing liver conditions, and any signs of liver dysfunction should be promptly evaluated.

Overdosage

Severe liver damage may occur if more than 4,000 mg of acetaminophen is taken within a 24-hour period. This risk is heightened if the product is used in conjunction with other medications containing acetaminophen or if the individual consumes three or more alcoholic drinks daily while using these products.

In cases where more than the recommended dosage is taken, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately. Quick medical attention is essential for both adults and children, even if no symptoms are initially apparent. Symptoms of overdose may include nausea, vomiting, loss of appetite, confusion, and jaundice, among others.

Healthcare professionals are advised to monitor patients closely for signs of liver damage and to provide appropriate interventions as necessary.

Nonclinical Toxicology

Teratogenic Effects

No specific teratogenic effects data are provided for the products reviewed. However, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use.

Non-Teratogenic Effects

The products may cause various non-teratogenic effects, including marked drowsiness, which can be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Additionally, excitability may occur, particularly in children. An allergy alert is noted for acetaminophen, which may lead to severe skin reactions, including skin reddening, blisters, rash, and other symptoms such as hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, immediate medical attention is recommended.

Nonclinical Toxicology

No specific nonclinical toxicology data are provided in the inserts for the reviewed products.

Animal Pharmacology and Toxicology

There is no specific animal pharmacology and toxicology data available in the inserts for the products assessed.

Storage and Handling

The products are supplied in various forms, including capsules and liquid-filled configurations. They are available in multiple packaging options to accommodate different consumer needs.

All products should be stored at room temperature, with specific temperature guidelines for some formulations. It is essential to avoid excessive heat, particularly temperatures above 40°C (104°F) for certain products. A few formulations have a more precise storage range, recommended to be kept between 20-25°C (68-77°F).

Additionally, for products that come in tamper-evident packaging, it is crucial to ensure that the carton is not open and that the blister unit is intact before use. Proper storage conditions are vital to maintain the efficacy and safety of the products.

Product Labels

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

FDA-Approved Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride 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 19 FDA Structured Product Labels (DailyMed) for Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride (marketed as Daytime Nighttime Cold and Flu, Non Drowsy Day and Night Multi-Symptom Cold and Flu Formula, Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu), with data retrieved by a validated AI data-extraction workflow. This includes 19 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.