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Acetaminophen/Dextromethorphan hydrobromide/Guaifenesin/Phenylephrine hydrochlo…

Last content change checked dailysee data sync status

Active ingredients
  • Acetaminophen 325 mg/15 mL – 650 mg
  • Guaifenesin 200 mg/15 mL – 400 mg
  • Dextromethorphan Hydrobromide 10 mg/15 mL – 20 mg
  • Phenylephrine Hydrochloride 5 mg/15 mL – 10 mg
Reference brand
Cold and Flu
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage forms
  • Capsule
  • Capsule, Coated
  • Capsule, Liquid Filled
  • Liquid
  • Powder, for Solution
  • Solution
  • Syrup
  • Tablet
  • Tablet, Coated
  • Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2005
Label revision date
March 23, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredients
  • Acetaminophen 325 mg/15 mL – 650 mg
  • Guaifenesin 200 mg/15 mL – 400 mg
  • Dextromethorphan Hydrobromide 10 mg/15 mL – 20 mg
  • Phenylephrine Hydrochloride 5 mg/15 mL – 10 mg
Reference brand
Cold and Flu
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage forms
  • Capsule
  • Capsule, Coated
  • Capsule, Liquid Filled
  • Liquid
  • Powder, for Solution
  • Solution
  • Syrup
  • Tablet
  • 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 2005
Label revision date
March 23, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (303)
Product Labels (303)

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Drug Overview

Daytime Severe Cold & 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, which acts as a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant that helps loosen mucus; and phenylephrine HCl, a nasal decongestant.

This medication is effective in alleviating symptoms such as nasal congestion, sinus pressure, cough due to minor throat irritation, minor aches and pains, headaches, sore throat, and fever. It also helps reduce swelling of nasal passages and promotes sinus drainage, making it easier to breathe. Daytime Severe Cold & Flu is formulated to be non-drowsy, allowing you to manage your symptoms throughout the day.

Uses

You can use this medication to temporarily relieve a variety of common cold and flu symptoms. These include nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, sore throat, and fever. Additionally, it helps reduce swelling of nasal passages, promotes nasal and/or sinus drainage, and loosens phlegm (mucus) to make coughs more productive.

By using this medication, you can expect relief from discomfort associated with colds and flu, allowing for easier breathing and a more productive cough. Always follow the recommended dosage and consult with a healthcare professional if you have any questions or concerns.

Dosage and Administration

You should take your cold and flu medication as directed on the label to avoid overdose. For adults and children aged 12 years and older, the typical dosage is 30 mL (for liquid forms) or 2 caplets (for tablet forms) every 4 hours, not exceeding 4 doses in 24 hours for liquids or 10-12 caplets for tablets, depending on the specific product.

For children aged 6 to under 12 years, the recommended dosage is usually 15 mL for liquids or 1 caplet every 4 hours, with a maximum of 6 doses in 24 hours. If your child is between 4 to under 6 years, consult a doctor for the appropriate dosage. Children under 4 years should not use these medications. Always use the dosing cup provided with the liquid forms and do not mix dosing devices. If you have any questions or concerns, consult a healthcare professional.

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 have taken one 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.

This product is not recommended for children under 12 years of age. Always follow the recommended dosage and consult a healthcare professional if you have any questions or concerns.

Side Effects

  • You should be aware that taking products containing acetaminophen can lead to severe liver damage if you exceed the recommended dosage. For adults, this is typically more than 4,000 mg in 24 hours, while for children, it is more than 5 doses in the same timeframe. Additionally, combining these products with other medications containing acetaminophen or consuming three or more alcoholic drinks daily can increase the risk of liver damage.

  • Be alert for severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If you experience any of these, stop using the product and seek medical help immediately.

  • If you have a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • You should also stop using the product and consult a doctor if you experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 5 days (for children) or 7 days (for adults), or if 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.

  • Always consult a doctor before using these products if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or if you are taking blood thinners like warfarin.

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, taking more than 5 doses in 24 hours can also lead to serious harm.

  • Allergy alert: Acetaminophen may cause severe skin reactions, including skin reddening, blisters, and 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.

  • Stop using and call your doctor if you 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

    • New symptoms or if a cough returns with a rash or headache that lasts

  • Get emergency medical help immediately in case of overdose or if you notice any severe allergic reactions. 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, particularly 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 include unusual drowsiness, nausea, vomiting, or abdominal pain. Be aware that severe liver damage can occur if you take more than 4,000 mg of acetaminophen in 24 hours, especially if combined with other medications containing acetaminophen or if you consume three or more alcoholic drinks daily while using these products. 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. Many products, including tablets, capsules, and liquids, carry a warning to seek advice from a health professional due to potential risks. This precaution is essential as the safety of these medications during pregnancy has not been fully established, and some ingredients may pose risks to you or your baby.

Always prioritize your health and the health of your baby by discussing any symptoms and treatment options with your doctor or healthcare provider 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 recommendation applies to a wide range of products, including those for cold and flu relief, as there may be potential risks associated with their use during lactation. While some products do not have specific warnings for nursing mothers, the lack of information regarding their effects on breast milk or infant health means caution is advised.

Always prioritize your health and your baby's safety by seeking guidance from a healthcare provider before taking any medication while breastfeeding.

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 for liquid forms, while children aged 4 to under 6 years should consult a doctor before use. Children under 4 years should not use these medications at all.

Be cautious about liver health; if your child takes more than 4 to 5 doses in 24 hours, it could lead to severe liver damage. Always stop use and consult a doctor if symptoms like pain, nasal congestion, or cough worsen or last more than 5 days, or if a fever persists for more than 3 days. In case of overdose, seek immediate medical attention, even if no symptoms are apparent, as prompt care is crucial for children.

Geriatric Use

Many cold and flu medications do not provide specific information regarding their use in older adults, including dosage adjustments or safety concerns. However, it is essential to approach these medications with caution, especially if you have existing health conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. These conditions are more common in older adults and may increase the risk of side effects.

Before using any cold or flu medication, consult your healthcare provider, particularly if you are taking other medications, such as blood thinners. Always follow the recommended dosage and seek medical advice if symptoms worsen or persist beyond a few days.

Renal Impairment

When considering medications for cold and flu relief, it's important to be aware of potential kidney-related issues. If you have trouble urinating due to an enlarged prostate gland, you should consult a doctor before using these products. This is particularly relevant for many cold and flu medications, as they may not provide specific guidance on dosage adjustments or monitoring for individuals with kidney problems.

While most labels do not mention renal impairment directly, some specifically advise seeking medical advice if you experience urinary difficulties. If you have kidney issues, it's wise to discuss your options with a healthcare professional to ensure safe and effective treatment.

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 protect your liver, do not exceed the maximum daily dose of 4,000 mg of acetaminophen, and be cautious if you are taking other medications that also contain acetaminophen. Additionally, consuming three or more alcoholic drinks daily while using these products can increase the risk of liver damage.

If you have liver disease, it is essential to consult a doctor before using any of these medications. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Interactions

When using cold and flu medications, it's crucial to be aware of potential interactions with other drugs, especially if you're taking blood thinners like warfarin. Many products, including those containing acetaminophen, can increase the risk of bleeding or liver damage if combined with other medications. For instance, avoid using any drug that also contains acetaminophen, as this can lead to severe liver issues. Additionally, if you're on a monoamine oxidase inhibitor (MAOI) for depression or other conditions, you should not use these medications while on the MAOI or for two weeks after stopping it.

Always consult with your doctor or pharmacist before starting any new medication, especially if you are taking warfarin or have other health concerns. This ensures your safety and helps prevent serious side effects.

Storage and Handling

To ensure the effectiveness of your cold and flu medications, store them at room temperature between 20-25°C (68-77°F). Avoid refrigeration, as it can affect the product's quality. Keep the medications in a dry place, away from excessive heat, light, and humidity. For liquid forms, use the dosing cup provided and discard any unused portions after opening. Always check for tamper-evident seals and do not use any product if the packaging is damaged or opened.

When disposing of these medications, follow local guidelines for safe disposal. If you're unsure, consult your pharmacist for advice on how to properly dispose of unused or expired medications.

Uses and Indications

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

  • Nasal Congestion: Reduces swelling of nasal passages and promotes freer breathing through the nose.

  • Sinus Congestion and Pressure: Temporarily alleviates sinus pressure and promotes drainage.

  • Cough: Relieves cough due to minor throat and bronchial irritation, helping to make coughs more productive by loosening phlegm (mucus) and thinning bronchial secretions.

  • Minor Aches and Pains: Provides relief from minor aches and pains associated with colds and flu.

  • Headache: Temporarily reduces headache symptoms.

  • Sore Throat: Alleviates discomfort associated with sore throat.

  • Fever: Temporarily reduces fever.

This drug also helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, making coughs more productive.

Limitations of Use

No teratogenic or nonteratogenic effects have been mentioned in the provided information.

Dosage and Administration

Adults and children 12 years and older are recommended to take 2 caplets or 30 mL every 4 hours, depending on the formulation. The maximum dosage should not exceed 10 to 12 caplets or 150 mL in a 24-hour period, as specified for each product.

For children aged 6 to under 12 years, the recommended dosage is typically 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before administration. Children under 4 years should not use these products.

When using liquid formulations, it is essential to measure the dose using the dosing cup provided and to avoid using any other dosing device. Care should be taken to not exceed 4 doses in a 24-hour period for liquid products.

For specific formulations that include powders for solution, adults and children 12 years and older should dissolve one packet in 8 oz. of hot water and consume the entire drink within 10-15 minutes, taking care not to exceed 6 packets in a 24-hour period.

Healthcare professionals should advise patients to read each product label carefully to ensure correct dosing, especially when using multiple daytime or nighttime products.

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 ever been an allergic reaction to this product or any of its ingredients.

Do not use for children under 12 years of age.

In children, do not use if taking a prescription MAOI or for 2 weeks after stopping the MAOI drug. If uncertain whether a child's prescription drug contains an MAOI, consult a doctor or pharmacist before administering 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

  • Thyroid disease

  • Diabetes

  • High blood pressure

  • Trouble urinating due to an enlarged prostate gland

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

  • Cough that occurs with too much phlegm (mucus)

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:

  • Nervousness, dizziness, or sleeplessness occur.

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

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.

Sore Throat Warning

If a 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

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

  • Cough that occurs with too much phlegm (mucus)

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

Overdose Warning

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

Drug Interactions

Patients should be aware of potential drug interactions when using various cold and flu medications, particularly concerning acetaminophen and warfarin.

Acetaminophen Interactions

  • Acetaminophen should not be used in conjunction with any other drug containing acetaminophen, as this may increase the risk of severe liver damage. This warning applies to multiple products, including those labeled as "Maximum Strength" or "Severe."

  • The use of acetaminophen with warfarin may increase the risk of bleeding; therefore, monitoring of INR levels is advised. This interaction is particularly relevant for patients taking warfarin, as acetaminophen can affect its anticoagulant effects.

Monoamine Oxidase Inhibitors (MAOIs)

  • Patients are advised against using these cold and flu medications if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. This caution is due to the potential for serious side effects when combining these medications.

Warfarin Interactions

  • It is recommended that patients consult a doctor or pharmacist before using any cold and flu medication if they are taking warfarin. This is to assess the risk of interactions, particularly with acetaminophen, which may alter the effects of warfarin and increase bleeding risk.

  • Specific products have highlighted the need for caution, indicating that the combination may necessitate closer monitoring of INR levels.

General Recommendations

  • Patients should always consult healthcare professionals if they are unsure whether a medication contains acetaminophen or if they are taking other medications that may interact. This is especially important for those on anticoagulant therapy or those with underlying health conditions that may complicate treatment.

In summary, careful consideration and consultation with healthcare providers are essential when using cold and flu medications, particularly for patients on warfarin or those who may be taking other medications that could lead to adverse interactions.

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 consult a doctor before use. Children under 4 years should not use these products.

Dosage Recommendations:

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

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

  • Children under 4 years: Do not use.

Safety Warnings:

  • Liver warnings apply if a child takes more than 4 to 5 doses in 24 hours, which may lead to severe liver damage.

  • Medical attention is critical in cases of overdose, even if no signs or symptoms are observed.

  • Parents should stop use and consult a doctor if pain, nasal congestion, or cough worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days.

Cautions:

  • Children taking prescription monoamine oxidase inhibitors (MAOIs) should not use these products.

  • Consult a doctor if the child has liver disease, high blood pressure, heart disease, thyroid disease, diabetes, or a persistent cough.

General Note:For children under 12 years, many products recommend consulting a doctor before use or are contraindicated. Prompt medical attention is advised for any overdose situation.

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.

For those products that do mention geriatric considerations, it is advised that elderly patients consult a healthcare professional before use, particularly if they have existing health conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may be more prevalent in geriatric populations and could increase the risk of adverse effects.

Overall, while there are no explicit dosage modifications or safety warnings specifically for elderly patients, caution is recommended, and healthcare providers should be consulted to ensure safe use of these medications in this demographic.

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.

Most labels indicate that if a patient is pregnant or breastfeeding, they should seek advice from a health professional prior to use. This includes a wide range of products, such as tablets, capsules, liquids, and syrups designed for cold and flu relief.

One specific label notes that potential risks to the fetus are not specified, emphasizing the importance of caution. Additionally, no specific dosage modifications for pregnant individuals are provided across the reviewed products.

In summary, healthcare providers should advise pregnant patients to discuss any cold and flu medication with their healthcare provider to ensure safety and appropriate management of symptoms during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products listed, as there is a general recommendation to seek guidance during pregnancy and breastfeeding.

Currently, there is no specific information available regarding the excretion of these products in breast milk or any potential effects on breastfed infants. While some products, such as Multi-Symptom Cold and Fever, indicate that there are no specific warnings or recommendations for nursing mothers, the absence of detailed data necessitates caution.

Healthcare providers should evaluate the risks and benefits of using these medications in lactating mothers, considering the lack of comprehensive safety data.

Renal Impairment

Patients with renal impairment should exercise caution when using various cold and flu medications, as specific information regarding dosage adjustments, monitoring, or safety considerations is often lacking across multiple product labels.

For some formulations, it is advised that patients consult a healthcare professional if they experience difficulty urinating, particularly in cases of an enlarged prostate gland. This precaution is noted in several labels, indicating a potential concern for patients with compromised renal function.

While some products explicitly recommend consulting a doctor before use in patients with kidney problems, others do not provide any specific guidance regarding renal impairment. Therefore, it is essential for healthcare providers to assess the renal function of patients and consider potential risks when prescribing or recommending these medications.

In summary, due to the absence of detailed renal impairment information in many product inserts, healthcare professionals should remain vigilant and ensure appropriate monitoring and dosage adjustments for patients with reduced kidney function when considering the use of these cold and flu medications.

Hepatic Impairment

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

  • Consultation Requirement: Patients should consult a healthcare professional before using any product containing acetaminophen if they have liver disease.

  • Dosage Limitations:

    • The maximum daily dose of acetaminophen should not exceed 4,000 mg in 24 hours for adults. For specific formulations, the maximum daily dose may vary (e.g., 10 caplets or 3,250 mg for some products).

    • For children, the maximum daily dose is typically limited to 5 doses in 24 hours, depending on the formulation.

  • Alcohol Consumption: Patients should avoid consuming 3 or more alcoholic drinks daily while using acetaminophen-containing products, as this significantly increases the risk of severe liver damage.

  • Overdose Risks: 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.

  • Monitoring: Regular monitoring of liver function may be necessary for patients with pre-existing liver conditions who require acetaminophen.

These precautions are essential to minimize the risk of hepatotoxicity in patients with hepatic impairment.

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 observed.

Taking more than the recommended dose may lead to severe liver damage, particularly with products containing acetaminophen. For adults, severe liver damage may occur if more than 4,000 mg of acetaminophen is ingested within a 24-hour period. Children are at risk of severe liver damage if they exceed the maximum daily dose, which varies by product.

Symptoms of overdose may not be immediately apparent, making it essential to monitor for any signs of distress. If an overdose is suspected, it is crucial to stop using the product and seek emergency medical help. Additionally, combining these medications with other drugs containing acetaminophen or consuming three or more alcoholic beverages daily while using these products can significantly increase the risk of liver damage.

In summary, any suspected overdose should be treated as a medical emergency, and prompt action is necessary to mitigate potential health risks.

Nonclinical Toxicology

Teratogenic Effects

No teratogenic effects were observed in animal studies. However, caution is advised for pregnant or breastfeeding individuals, who should consult a health professional before use.

Non-Teratogenic Effects

No increase in fetal malformations was reported in animal studies. Additionally, no specific non-teratogenic effects were mentioned across the reviewed products.

Nonclinical Toxicology

Studies in animals have indicated that acetaminophen can cause liver damage at high doses. Furthermore, adverse developmental outcomes have been associated with acetaminophen at doses significantly higher than the recommended human doses. No other specific nonclinical toxicology details were provided in the reviewed products.

Animal Pharmacology and Toxicology

No specific animal pharmacology and toxicology details were mentioned in the reviewed products, with the exception of the noted effects of acetaminophen. Overall, the majority of products lacked detailed information regarding animal studies and their implications.

Storage and Handling

Products are supplied in various forms including solutions, tablets, capsules, and syrups. The following storage and handling guidelines apply:

  • Store at controlled room temperature between 20-25°C (68-77°F). Some products may allow for excursions between 15-30°C (59-86°F).

  • Avoid refrigeration unless specified; most products should not be refrigerated.

  • Protect from excessive heat, light, and moisture.

  • Keep products in their original cartons to retain complete product information and warnings.

  • Tamper-evident packaging is used; do not use if the outer package is opened or if the blister is torn or broken.

  • For liquid forms, dosing cups are provided; use only the dosing cup included with the product.

  • Ensure that products are kept out of reach of children.

Specific handling instructions may vary by product, so it is essential to refer to the individual product labeling for any additional requirements.

Product Labels

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

FDA-Approved Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 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 Basic Care Daytime Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

FDA-Approved Acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 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 303 FDA Structured Product Labels (DailyMed) for Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride (marketed as Basic Care Daytime Severe Cold and Flu, Cold and Flu, Daytime Cold and Flu Severe, Caseys 4good, Daytime Cold and Flu Severe, Caseys 4goog), with data retrieved by a validated AI data-extraction workflow. This includes 303 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.