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Daytime Severe Cold and Cough

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Active ingredients
  • Acetaminophen 650 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
  • Phenylephrine Hydrochloride 10 mg/30 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
April 8, 2024
Active ingredients
  • Acetaminophen 650 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
  • Phenylephrine Hydrochloride 10 mg/30 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
April 8, 2024
Manufacturer
H E B
Registration number
M012
NDC root
37808-718

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Drug Overview

Severe Cold & Cough is a medication designed to help relieve common cold symptoms for individuals aged 12 years and older. It contains three active ingredients: acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), and phenylephrine HCl (a nasal decongestant). Together, these ingredients work to temporarily alleviate symptoms such as minor aches and pains, headaches, nasal and sinus congestion, sore throats, and coughs caused by throat and bronchial irritation, while also helping to reduce fever.

This product is available in a pleasant berry flavor and is formulated to provide relief from discomfort associated with colds, making it easier for you to feel better during illness.

Uses

You can use this medication to temporarily relieve symptoms associated with the common cold. It helps ease minor aches and pains, headaches, nasal and sinus congestion, sore throats, and coughs caused by minor throat and bronchial irritation. Additionally, it can help reduce fever for a short period.

This medication is designed to provide comfort when you're feeling under the weather, making it easier to manage your cold symptoms.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety. For adults and children aged 12 years and older, you should take 30 mL every 4 hours, but make sure not to exceed 6 doses (which totals 180 mL) in a 24-hour period.

To measure your dose accurately, always use the dosing cup that comes with the product. Avoid using any other measuring devices, as this can lead to incorrect dosing. Keep the dosing cup with the product to ensure you have it on hand whenever you need to take your medication. If you are caring for children under 12 years of age, do not use this medication for them. Always remember to stick to the recommended dosage to avoid any potential overdose.

What to Avoid

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

It's also important to follow the recommended dosage and not exceed it. Taking more than the recommended amount can lead to serious health risks. Always prioritize your safety by adhering to these guidelines.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately.

You should consult a doctor if you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, stop using the product and seek medical advice if you experience nervousness, dizziness, sleeplessness, worsening pain, cough, nasal congestion, or if new symptoms develop. It's important to talk to a healthcare professional before using this product if you have certain health conditions, such as liver or heart disease, or if you are taking blood thinners like warfarin. Remember, taking more than the recommended dose can be dangerous, so seek immediate medical attention in case of an overdose.

Warnings and Precautions

It's important to be aware of some key warnings when using this product. First, it 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 three or more alcoholic drinks daily while using it. Additionally, be cautious of potential severe skin reactions, such as redness, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, it's wise to talk to your doctor if you have any existing health conditions, such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or if you have trouble urinating due to an enlarged prostate. If you're taking the blood thinner warfarin, check with your doctor or pharmacist before use. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 right away, even if you don't notice any symptoms.

You should stop taking this product and call your doctor if you experience nervousness, dizziness, or sleeplessness, if your pain, cough, or nasal congestion worsens or lasts more than seven days, if your fever worsens or lasts more than three days, or if you notice any redness or swelling. New symptoms or a returning cough, especially if accompanied by a rash or headache, could indicate a serious condition that requires medical attention.

Overdose

Taking more than the recommended dose of this medication can lead to serious liver damage. If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial, both for adults and children, even if you don’t see any signs or symptoms of an overdose.

Remember, being aware of the risks and knowing what to do in case of an overdose can make a significant difference in ensuring safety. Always err on the side of caution and reach out for help if you have any concerns.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when using this medication for children. If your child is under 12 years old, you should not use this product. For those aged 12 and older, the recommended dosage is 30 mL every 4 hours. Always keep the medication out of reach of younger children to prevent accidental ingestion.

In the event of an overdose, it's crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is vital, even if your child shows no signs or symptoms of overdose.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present.

Always keep in mind that older adults may have different responses to medications, so regular monitoring and open communication with your healthcare team are essential for safety and effectiveness.

Renal Impairment

If you have kidney issues, it's important to consult your doctor before using this medication, especially if you have trouble urinating due to an enlarged prostate gland. This condition can affect how your body processes the medication. Additionally, if you are taking warfarin, a blood-thinning medication, be sure to speak with your doctor or pharmacist before starting this treatment, as it may interact with your current medications. Always prioritize open communication with your healthcare provider to ensure your safety and well-being.

Hepatic Impairment

If you have liver disease, it's important to consult your doctor before using this product. Be aware that it contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in a 24-hour period, take it alongside other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it.

Additionally, taking more than the recommended dose can result in an overdose, potentially causing liver damage. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you don't notice any symptoms.

Drug Interactions

It's important to be cautious when taking this medication, especially regarding potential interactions with other drugs. You should avoid using it alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are currently taking a prescription monoamine oxidase inhibitor (MAOI)—which is a type of medication used for depression, certain psychiatric conditions, or Parkinson’s disease—or if you have stopped taking one in the last two weeks, you should not use this medication.

Before starting this medication, it's also wise to consult with your doctor or pharmacist if you are taking warfarin, a blood-thinning medication. Discussing all your current medications and any health conditions with your healthcare provider can help ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25ºC (68-77ºF). It's important to avoid refrigeration, as this can affect its effectiveness.

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

Additional Information

No further information is available.

FAQ

What is Severe Cold & Cough used for?

Severe Cold & Cough temporarily relieves common cold symptoms such as minor aches and pains, headache, nasal congestion, sore throat, and cough due to minor throat and bronchial irritation.

What are the active ingredients in Severe Cold & Cough?

The active ingredients include Acetaminophen (650 mg) as a pain reliever and fever reducer, Dextromethorphan HBr (20 mg) as a cough suppressant, and Phenylephrine HCl (10 mg) as a nasal decongestant.

Who can use Severe Cold & Cough?

Severe Cold & Cough is intended for adults and children aged 12 years and over. Children under 12 years of age should not use this product.

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

The recommended dosage is 30 mL every 4 hours, not to exceed 6 doses (180 mL) in any 24-hour period.

What should I do if I experience severe skin reactions?

If you experience severe skin reactions such as reddening, blistering, or rash, stop using the product and seek medical help immediately.

Are there any warnings associated with Severe Cold & Cough?

Yes, there are several warnings, including a liver warning for acetaminophen, allergy alerts for skin reactions, and a sore throat warning if symptoms persist.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away, as quick medical attention is critical.

Can I take Severe Cold & Cough with other medications?

Do not use Severe Cold & Cough with any other drug containing acetaminophen or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

What should I do if I have liver disease?

If you have liver disease, consult a doctor before using Severe Cold & Cough, as it contains acetaminophen which can cause severe liver damage.

Is it safe to use Severe Cold & Cough during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Severe Cold & Cough.

Packaging Info

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

Packaging configurations for Daytime Severe Cold and Cough.
Details

Drug Information (PDF)

This file contains official product information for Daytime Severe Cold and Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Acetaminophen, at a dosage of 650 mg, serves as a pain reliever and fever reducer. Dextromethorphan HBr is included at 20 mg, functioning as a cough suppressant. Additionally, Phenylephrine HCl is present at 10 mg, acting as a nasal decongestant. The formulation contains 10% alcohol and is flavored with berry. This product is intended for use by individuals aged 12 years and older. It is tamper evident; do not use if the printed safety seal around or under the cap is broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of common cold symptoms, including minor aches and pains, headache, nasal and sinus congestion, sore throat, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever associated with these symptoms.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 30 mL administered every 4 hours as needed. It is imperative that no more than 6 doses (180 mL) are taken within a 24-hour period.

Healthcare professionals should instruct patients to measure the dosage exclusively with the dosing cup provided with the product, as the use of any other dosing device is not advised. The dosing cup should be kept with the product to ensure proper measurement.

For children under 12 years of age, the use of this product is not recommended. It is essential to adhere strictly to the dosing guidelines to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen may also cause severe skin reactions. Symptoms indicative of such reactions include skin reddening, blistering, and rash. Should any of these symptoms occur, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be encouraged to consult a healthcare provider if they have liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, those with a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, should seek medical advice before using this product. It is also important for patients taking the anticoagulant warfarin to consult a doctor or pharmacist prior to use.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are present.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than usual. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

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

A sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

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

Prior to use, patients should consult a healthcare professional if they have a history of liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm or chronic conditions such as smoking, asthma, or emphysema. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product.

An overdose of acetaminophen can lead to liver damage. In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects, including hypertensive crises.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could affect bleeding risk.

Packaging & NDC

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

Packaging configurations for Daytime Severe Cold and Cough.
Details

Pediatric Use

Children under 12 years of age should not use this medication. For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

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

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, as interactions may necessitate careful monitoring and potential dosing adjustments.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. Due to the presence of acetaminophen, there is a significant risk of severe liver damage if the total daily dosage exceeds 4,000 mg, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic beverages daily while using this product.

In cases of overdose, which is defined as taking more than the recommended dose, there is a potential for liver damage. Immediate medical attention is essential in the event of an overdose, and patients are advised to seek help or contact a Poison Control Center (1-800-222-1222) without delay. This is critical for both adults and children, even if no signs or symptoms of overdose are apparent. Monitoring of liver function may be warranted in patients with compromised liver function to prevent adverse effects associated with acetaminophen use.

Overdosage

Taking more than the recommended dose of this medication may lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent. Healthcare professionals should be vigilant in assessing the situation and providing appropriate interventions.

Potential Symptoms

While specific symptoms of overdose are not detailed, the risk of liver damage underscores the importance of monitoring for any signs of hepatic impairment following an overdose.

Management Procedures

Upon recognition of an overdose, healthcare providers should initiate standard emergency protocols, which may include supportive care and monitoring of liver function. Early intervention can significantly impact patient outcomes.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blistering, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

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

Patients should be made aware that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition. It is essential to stress that patients must not exceed the recommended dosage while using this product.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Daytime Severe Cold and Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Daytime Severe Cold and Cough, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

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

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

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