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Acetaminophen/Dextromethorphan hydrobromide/Phenylephrine hydrochloride

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Active ingredients
  • Acetaminophen 500 mg/237 mL – 650 mg
  • Dextromethorphan Hydrobromide 20 mg/237 mL – 20 mg/5 g
  • Phenylephrine Hydrochloride 10 mg/237 mL – 10 mg/5 g
Reference brand
Daytime Cold and Flu
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage forms
  • Capsule
  • Capsule, Liquid Filled
  • Granule, for Solution
  • Liquid
  • Powder
  • Powder, for Solution
  • Solution
  • Syrup
  • Tablet
  • Tablet, Coated
  • Tablet, Effervescent
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1989
Label revision date
March 23, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredients
  • Acetaminophen 500 mg/237 mL – 650 mg
  • Dextromethorphan Hydrobromide 20 mg/237 mL – 20 mg/5 g
  • Phenylephrine Hydrochloride 10 mg/237 mL – 10 mg/5 g
Reference brand
Daytime Cold and Flu
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage forms
  • Capsule
  • Capsule, Liquid Filled
  • Granule, for Solution
  • Liquid
  • Powder
  • Powder, for Solution
  • Solution
  • Syrup
  • Tablet
  • Tablet, Coated
  • Tablet, Effervescent
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1989
Label revision date
March 23, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (217)
Product Labels (217)

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Drug Overview

Daytime Cold and Flu is a multi-symptom relief medication designed to temporarily alleviate common cold and flu symptoms. It contains three active ingredients: acetaminophen, which acts as a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. This combination helps relieve symptoms such as nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

This medication is suitable for daytime use as it is non-drowsy and alcohol-free, making it a convenient option for those needing relief while going about their daily activities. It is intended for individuals aged 6 years and older.

Uses

You can use this medication to temporarily relieve symptoms associated with the common cold and flu. It helps alleviate minor aches and pains, headaches, sore throats, nasal congestion, and coughs caused by minor throat and bronchial irritation. Additionally, it can reduce fever and promote nasal and sinus drainage, making it easier to breathe.

If you're experiencing symptoms like sinus pressure or congestion, this medication can also assist in clearing nasal passages. It's designed to provide relief from the discomfort of cold and flu symptoms, helping you feel better while your body fights off the illness.

Dosage and Administration

You should take the medication as directed on the label to ensure safety and effectiveness. For adults and children aged 12 years and older, the typical dosage is 30 mL (or 2 softgels) every 4 hours, not exceeding 4 doses in a 24-hour period. If you are using softgels, swallow them whole with water; do not crush, chew, or dissolve them.

For children aged 6 to under 12 years, the dosage is usually 15 mL every 4 hours, while for children aged 4 to under 6 years, you should consult a doctor before use. Children under 4 years should not use this medication. Always measure the liquid with the dosing cup provided and keep it with the product. If you are taking both daytime and nighttime medications, carefully read each label to ensure correct dosing.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) (a type of medication for depression, psychiatric conditions, or Parkinson's disease) or if you have stopped taking an MAOI within the last two weeks. Additionally, do not use this product in conjunction with any other medications containing acetaminophen (a common pain reliever). If you are unsure whether a medication contains acetaminophen, consult a doctor or pharmacist.

It is also important not to exceed the recommended dosage. If you have ever had an allergic reaction to this product or any of its ingredients, do not use it. For children under 12 years of age, this product should not be used. If you experience an overdose, seek medical help immediately.

Side Effects

  • You may experience severe liver damage if you take more than 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 this product.

  • Be aware that acetaminophen can cause severe skin reactions, including skin reddening, blisters, and rash. If you notice any of these symptoms, 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 consult a doctor if you experience nervousness, dizziness, or sleeplessness, if your pain, cough, or nasal congestion worsens or lasts more than 5 days (for children) or 7 days (for adults), or if your fever worsens or lasts more than 3 days. New symptoms or a cough that returns with a rash or headache could indicate a serious condition.

  • Before using this product, consult a doctor if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or if you have trouble urinating due to an enlarged prostate gland. Additionally, if you are taking the blood-thinning medication warfarin, consult a doctor or pharmacist before use.

Warnings and Precautions

  • This product contains acetaminophen, which can cause severe liver damage if you take more than 4,000 mg in 24 hours, take it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it. For children, the maximum dosage varies, so consult the label for specifics.

  • Allergy alert: Acetaminophen may lead to serious skin reactions, including skin reddening, blisters, or rash. If you experience any of these symptoms, 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.

  • General precautions: Before using this product, ask a doctor if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or if you have trouble urinating due to an enlarged prostate. Also, consult a doctor if you are taking the blood-thinning medication warfarin.

  • Stop using and call your doctor if you experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than 5 days (children) or 7 days (adults); 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.

  • In case of overdose, seek emergency 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

Taking more than the recommended dose of cold and flu medications can lead to serious health issues, including liver damage. 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 no symptoms are apparent.

Signs of overdose may not always be obvious, so it's important to be vigilant. Remember, severe liver damage can occur if you exceed the maximum daily dose, especially if you consume alcohol or take other medications containing acetaminophen at the same time. Always follow the dosing instructions carefully to avoid these risks.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any cold or flu medications. This includes various forms such as capsules, liquids, and solutions. The safety of these products during pregnancy has not been fully established, and a healthcare provider can help assess the risks and benefits based on your specific situation.

Always prioritize your health and the health of your baby by seeking professional advice before taking any medication.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any medications. This is because certain substances can be excreted in breast milk, meaning they can pass into your breast milk and potentially affect your baby. Always prioritize your health and your baby's safety by seeking professional advice before taking any medication during this time.

Pediatric Use

You should be cautious when using cold and flu medications for children. For children under 4 years old, do not use these products at all. For children aged 4 to under 12 years, it's important to consult a doctor before use. If your child is between 6 and 12 years old, the typical dosage is 15 mL every 4 hours for liquid forms, while softgel forms generally require 2 softgels every 4 hours for those 12 years and older.

Always monitor your child's symptoms closely. If symptoms worsen or last more than 5 days, or if a fever lasts more than 3 days, you should stop use and consult a doctor. Be aware that giving more than the recommended doses can lead to serious health risks, including liver damage, so it's crucial to follow the dosing instructions carefully. In case of overdose, seek medical help immediately, even if no symptoms are apparent.

Geriatric Use

When considering cold and flu medications, it's important to note that many products do not provide specific information regarding their use in older adults. While there are no explicit dosage adjustments or safety concerns mentioned for elderly patients, it is generally advised to consult a healthcare provider before use, especially if you have underlying health conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary issues related to an enlarged prostate.

Elderly individuals may experience increased sensitivity to side effects, so monitoring for any adverse reactions is crucial. If symptoms worsen or new symptoms arise, it is recommended to stop using the medication and seek medical advice. Always prioritize safety and consult with a healthcare professional to ensure the best care for your health needs.

Renal Impairment

When considering medications for cold and flu relief, it's important to be aware of potential issues if you have kidney problems. Most products do not provide specific information regarding dosage adjustments or monitoring for individuals with renal impairment. However, if you have difficulty urinating due to an enlarged prostate gland, it is advisable to consult a doctor before using these medications. This precaution is particularly relevant for various formulations, including capsules, liquids, and solutions.

Always prioritize your health by discussing any concerns with your healthcare provider, especially if you are taking other medications or have underlying health conditions.

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 the maximum daily dose of acetaminophen, which is typically 4,000 mg for adults. Additionally, 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. In case of an overdose, seek immediate medical help or contact a Poison Control Center (1-800-222-1222), as quick medical attention is crucial for both adults and children, even if no symptoms are present.

Drug Interactions

When using cold and flu medications, it's crucial to be aware of potential interactions, especially if you're taking other medications. For instance, avoid using any product containing acetaminophen alongside another acetaminophen-containing drug, as this can lead to severe liver damage. If you're on a blood thinner like warfarin, consult your doctor or pharmacist before using these products, as acetaminophen may increase bleeding risk and affect your INR levels, which is a measure of how well your blood clots.

Additionally, if you're taking monoamine oxidase inhibitors (MAOIs), a type of medication for depression or certain other conditions, do not use products containing dextromethorphan for at least two weeks after stopping the MAOI, due to the risk of serious interactions. Always discuss your current medications and any new treatments with your healthcare provider to ensure your safety.

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). Some products may allow for storage between 15-30°C (59-86°F), but avoid exposing them to excessive heat above 40°C (104°F) and high humidity. It's important not to refrigerate these medications, as this can affect their potency.

When handling the product, check for any tampering; do not use if the outer package is opened or if the seal is broken. Always keep the medication in its original carton for complete information and warnings. For disposal, follow local guidelines, and ensure that any unused or expired medications are disposed of safely.

Uses and Indications

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

  • General Symptoms:

    • Minor aches and pains

    • Headache

    • Sore throat

    • Fever

  • Respiratory Symptoms:

    • Nasal congestion

    • Cough due to minor throat and bronchial irritation

    • Sinus congestion and pressure

This drug also helps to clear nasal passages and promotes nasal and sinus drainage. It temporarily reduces fever and alleviates sinus pressure.

Limitations of Use

No teratogenic or nonteratogenic effects have been mentioned for this drug.

Dosage and Administration

Adults and children 12 years and older are recommended to take 30 mL (2 tablespoons) of the liquid formulation or 2 softgels with water every 4 hours. The maximum allowable dosage is 4 doses (120 mL or 8 softgels) within a 24-hour period.

For children aged 6 to under 12 years, the dosage is 15 mL (1 tablespoon) every 4 hours, not to exceed 4 doses in a 24-hour period. Children aged 4 to under 6 years should consult a doctor before use, while those under 4 years should not use the product.

It is essential to measure the liquid formulation using only the dosing cup provided with the product; other dosing devices should not be used. The dosing cup should be kept with the product to ensure accurate measurement.

When using other daytime or nighttime products, healthcare professionals should advise patients to carefully read each label to ensure correct dosing and avoid potential overdose.

Contraindications

Do not use in patients 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 unsure whether a prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

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

Do not use if there is a known allergy to this product or any of its ingredients.

Do not use in children under 12 years of age.

In patients with a history of allergic reactions to this product or its ingredients, use is contraindicated.

Avoid use for more than 10 days for pain or more than 3 days for fever unless directed by a doctor.

Exceeding the recommended dosage is not advised.

Alcoholic beverages should be avoided while using this product.

Warnings and Precautions

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

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

  • A child takes more than 5 doses in 24 hours.

  • Taken with other drugs containing acetaminophen.

  • An adult has 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

  • Thyroid disease

  • Diabetes

  • Trouble urinating due to an enlarged prostate gland

  • Cough that occurs with too much phlegm (mucus)

  • 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.

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.

Get Emergency Medical Help In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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

  • Nervousness, dizziness, or sleeplessness occurs.

  • 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, take with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, with symptoms including skin reddening, blisters, and rash. If a skin reaction occurs, patients should stop use and seek medical help immediately.

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

Stop Use and Ask a Doctor If

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

  • Nervousness, dizziness, or sleeplessness

  • Pain, nasal congestion, or cough that worsens or lasts more than 5 days (children) or 7 days (adults)

  • Fever that worsens or lasts more than 3 days

  • Redness or swelling is present

  • New symptoms occur

  • Cough returns or occurs with rash or headache that lasts, as these could be signs of a serious condition.

Additional Warnings

Patients should ask a doctor before use if they have:

  • Liver disease

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • Trouble urinating due to an enlarged prostate gland

  • A cough that occurs with too much phlegm (mucus)

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

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

Overdose Warning

Taking more than the recommended dose may cause serious health problems, including liver damage. In case of overdose, patients should seek medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults and children, even if no signs or symptoms are noticed.

Drug Interactions

Acetaminophen-containing products are associated with several important drug interactions, particularly concerning the anticoagulant warfarin. The use of acetaminophen may increase the risk of severe liver damage when taken with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily. Additionally, patients taking warfarin should consult a healthcare professional before using acetaminophen, as it may enhance the effects of warfarin, leading to an increased risk of bleeding. Close monitoring of International Normalized Ratio (INR) levels is advised for those using these combinations.

Dextromethorphan, another common ingredient in cold and flu medications, should not be used in conjunction with monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping an MAOI due to the potential for serious interactions. This caution applies to various formulations that include dextromethorphan.

Specific products have highlighted the need for consultation with a healthcare provider before use if the patient is currently taking warfarin. This includes a wide range of cold and flu medications, indicating a general consensus on the importance of monitoring and potential interactions.

In summary, the key interactions to monitor include:

  • Acetaminophen and Warfarin: Increased risk of bleeding; monitor INR closely.

  • Dextromethorphan and MAOIs: Avoid use to prevent severe interactions.

  • Acetaminophen with Alcohol: Increased risk of liver damage.

Healthcare professionals should be consulted for any questions regarding the use of these medications in conjunction with other treatments, particularly for patients on anticoagulant therapy.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a doctor before using these medications. For children under 4 years, these products are contraindicated and should not be used.

Dosing Information:

  • Children 6 to under 12 years: Administer 15 mL every 4 hours for liquid formulations. For capsule or softgel forms, the recommended dose is 2 softgels every 4 hours for those aged 12 years and older, not to exceed 4 doses in 24 hours.

  • Children 4 to under 6 years: Consultation with a doctor is advised before use.

  • Children under 4 years: Do not use.

Safety and Efficacy:

  • Symptoms in pediatric patients should be monitored closely. If symptoms worsen or persist for more than 5 days, or if fever lasts more than 3 days, a doctor should be consulted.

  • Overdose warnings are critical; quick medical attention is necessary for both children and adults, even if no signs or symptoms are observed. Liver damage may occur if a child takes more than the recommended doses in 24 hours.

General Warnings:

  • Keep out of reach of children.

  • In case of overdose, seek immediate medical help or contact a Poison Control Center.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the majority of the products reviewed.

However, for one product, it is advised that elderly patients consult a doctor before use if they have underlying conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary issues related to an enlarged prostate gland. Additionally, it is noted that elderly patients may exhibit increased sensitivity to side effects, although this is not explicitly stated for all products.

Monitoring is recommended, with a suggestion to discontinue use and consult a healthcare provider if symptoms worsen or new symptoms arise, which may be particularly important for elderly patients who may respond differently to medications.

Overall, healthcare professionals should exercise caution and consider individual patient factors when prescribing these medications to geriatric patients.

Pregnancy

Pregnant patients should consult a healthcare professional before using any of the products listed, as the safety of these medications during pregnancy has not been established. The available data indicates that there may be potential risks associated with the use of these medications in pregnant individuals, particularly during the first trimester when fetal development is critical.

Fetal outcomes may be affected by the use of medications during pregnancy, and it is essential for healthcare providers to evaluate the benefits versus risks for each patient. The general recommendation is to avoid self-medication and to seek professional guidance to ensure the safety of both the mother and the developing fetus.

All products listed, including various formulations such as capsules, liquids, and powders, carry the precaution that pregnant or breastfeeding individuals should ask a healthcare professional before use. This precaution underscores the importance of individualized care and the need for thorough risk assessment in pregnant patients.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products listed, as the safety of these medications during breastfeeding has not been established. There is no specific data provided regarding the excretion of these medications in breast milk or their potential effects on breastfed infants.

Given the lack of detailed information on the pharmacokinetics and safety profiles of these products in lactating women, healthcare providers should exercise caution and consider alternative treatments when necessary. It is essential for lactating mothers to prioritize their health while ensuring the safety of their infants.

Renal Impairment

Patients with renal impairment should be aware that most product labels reviewed do not provide specific information regarding dosage adjustments, monitoring, or safety considerations for those with reduced kidney function.

However, several labels do include a precautionary note advising patients to consult a healthcare professional if they experience difficulty urinating, particularly in the context of an enlarged prostate gland. This recommendation is consistent across multiple products, indicating a potential concern for urinary retention or related complications in patients with renal impairment.

Given the lack of detailed guidance on renal dosing adjustments or monitoring, healthcare providers should exercise caution when prescribing these medications to patients with compromised kidney function. It is advisable for such patients to discuss their renal status with their healthcare provider before initiating treatment with any of the reviewed products.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using products containing acetaminophen. The following guidelines apply:

  • Liver Warning: Severe liver damage may occur if patients exceed the following limits:

    • Adults should not take more than 4,000 mg of acetaminophen in 24 hours.

    • Children should not take more than the specified maximum doses, which vary by product (e.g., 15 mL for children aged 6 to 12 years).

    • Patients should avoid taking acetaminophen with other medications that also contain acetaminophen.

    • Consumption of 3 or more alcoholic drinks daily while using these products may increase the risk of liver damage.

  • Dosage Recommendations: The maximum daily dose varies by product, with some formulations allowing for a maximum of 4 doses in 24 hours, while others may allow up to 10 softgels or 12 caplets. It is crucial for patients to adhere strictly to the recommended dosing guidelines.

  • Monitoring Requirements: Patients with liver disease should consult a healthcare provider before using any acetaminophen-containing products. Regular monitoring of liver function may be necessary, especially in those with pre-existing liver conditions.

  • Overdose Warning: Taking more than the recommended dose can lead to serious liver damage. In the event of an overdose, immediate medical attention is critical. Patients should contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent.

  • Consultation: Patients are advised to seek medical advice before using these products if they have liver disease or any other significant health concerns.

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 symptoms are immediately apparent.

Taking more than the recommended dose can lead to serious health issues, including severe liver damage. For adults, severe liver damage may occur if more than 4,000 mg of acetaminophen is consumed within a 24-hour period, or if more than the maximum daily doses are taken. Children are at risk of severe liver damage if they exceed the specified maximum daily doses, which vary by product. Additionally, combining these medications with other drugs containing acetaminophen or consuming three or more alcoholic drinks daily while using these products significantly increases the risk of liver damage.

Symptoms of overdose may not be immediately noticeable, making it essential to err on the side of caution and seek professional help if an overdose is suspected.

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 are not provided in the inserts for most products.

Non-Teratogenic Effects

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

Nonclinical Toxicology

The inserts for the reviewed products do not provide any specific details regarding nonclinical toxicology.

Animal Pharmacology and Toxicology

There is a lack of information regarding animal pharmacology and toxicology in the inserts for the reviewed products.

Storage and Handling

Products are supplied in various forms including liquid, solution, capsule, liquid filled, tablet, and syrup. The storage conditions for these products generally require them to be kept at room temperature, specifically between 15-30°C (59-86°F) or 20-25°C (68-77°F), depending on the specific product.

Storage Conditions

  • Room Temperature: Most products should be stored at room temperature, with specific ranges often noted as 15-30°C (59-86°F) or 20-25°C (68-77°F).

  • Avoid Excessive Heat: It is crucial to avoid exposing products to excessive heat, particularly temperatures above 40°C (104°F).

  • Humidity and Light Protection: Certain products require protection from high humidity and light to maintain their efficacy.

Handling Requirements

  • Do Not Refrigerate: Many liquid formulations explicitly state that they should not be refrigerated.

  • Tamper Evident: Products with tamper-evident packaging should not be used if the outer package is opened or if the blister is torn or broken.

  • Expiration Dates: Users should refer to the expiration date and lot number printed on the packaging for safety and efficacy.

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, and phenylephrine hydrochloride. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Acetaminophen, dextromethorphan hbr, phenylephrine hcl Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
More Details

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

Below are the non-prescription pack sizes of Daytime Cold and Flu (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

FDA-Approved Acetaminophen, dextromethorphan hbr, phenylephrine hcl Repack / Relabels showing repack and relabel formulations with forms, routes, strengths, and FDA years.
Label
Forms
Routes
Strength range
FDA year
Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 217 FDA Structured Product Labels (DailyMed) for Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl (marketed as Daytime Cold and Flu, Good Sense Daytime, Daytime Cold/Flu Relief), with data retrieved by a validated AI data-extraction workflow. This includes 217 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.