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Cold and Flu Relief

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Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
May 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
May 10, 2025
Manufacturer
Rite Aid Corporation
Registration number
M012
NDC root
11822-0640
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Severe Cold & Flu Relief is a medication designed to temporarily alleviate the symptoms associated with the common cold and flu. It helps relieve minor aches and pains, reduces swelling in the nasal passages, and promotes easier breathing by clearing nasal congestion. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, making coughs more productive.

This product contains several active ingredients, including acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), guaifenesin (an expectorant), and phenylephrine HCl (a nasal decongestant). Together, these components work to relieve symptoms such as headache, fever, sore throat, cough, and chest congestion, providing you with comfort during your illness.

Uses

If you're dealing with the discomfort of a common cold or flu, this medication can help temporarily relieve a variety of symptoms. You may find relief from minor aches and pains, sinus congestion and pressure, sore throat, fever, headache, nasal congestion, and cough caused by minor throat and bronchial irritation.

Additionally, this medication works to reduce swelling in your nasal passages, making it easier for you to breathe through your nose. It also promotes drainage in your nasal and sinus areas, helping to loosen phlegm (mucus) and thin bronchial secretions. This can make your coughs more productive by clearing out bothersome mucus from your bronchial passageways.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take 2 caplets with a glass of water every 4 hours as needed. However, make sure not to exceed 8 caplets in a 24-hour period.

If you are considering giving this medication to a child under 12 years old, it's best to consult with a doctor first to determine the appropriate dosage. Always remember to take only the amount directed to avoid any potential risks.

What to Avoid

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

It's also important not to use this product if you have ever experienced an allergic reaction to it or any of its ingredients. Your safety is paramount, so please follow these guidelines closely.

Side Effects

You should be aware of some important side effects and warnings associated with this product. It contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in a 24-hour period, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, acetaminophen may cause serious skin reactions, such as blisters, rash, or skin reddening. If you experience any of these symptoms, stop using the product and seek medical help immediately.

It's also important to consult a doctor if you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting. You should stop using the product and contact a healthcare professional if you experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, cough lasting more than seven days, or if new symptoms develop. These could indicate a more serious condition.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use 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 blisters or rashes. If you notice any skin issues, stop using the product and seek medical help immediately. Additionally, 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 important to talk to your doctor if you have any of the following conditions: liver disease, thyroid disease, diabetes, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a persistent cough. If you are taking the blood thinner warfarin, consult your doctor or pharmacist before use. If you experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days, or if your fever worsens or lasts more than three days, stop taking the product and call your doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, even if you do not notice any symptoms.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t wait—get help right away. Remember, acting quickly can make a significant difference in the outcome.

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

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 caplets taken with water every 4 hours, but be sure not to exceed 8 caplets in a 24-hour period. Always follow these guidelines to ensure safe and effective use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Additionally, if you have liver disease, you should also seek medical advice before starting this treatment. Your healthcare provider can help determine the best approach for your specific situation and ensure your safety while using the medication.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. This risk increases if you are also taking other medications that contain acetaminophen or if you consume three or more alcoholic drinks each day while using this product.

Before using this product, you should consult with your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.

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)—a type of medication often used for depression or certain other conditions—or have taken one in the past 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 quality and safety of your product, store it at room temperature, ideally around 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F). Always check the end flap for the expiration date and lot number to confirm its validity.

When handling the product, be cautious: do not use it if the outer package is opened or if the blister (the sealed compartment holding the product) is torn or broken. This tamper-evident feature is crucial for your safety, so always inspect the packaging before use.

Additional Information

If you are considering using this medication, it's important to know how to take it properly. For adults and children aged 12 and over, you should take 2 caplets with water every 4 hours. If the patient is under 12 years old, consult a doctor for guidance.

Additionally, if you are pregnant or breastfeeding, it's essential to speak with a healthcare professional before using this medication. Be aware of the potential for medicine abuse, especially among teens; you can find more information at Stop Medicine AbuseStop Medicine Abuse.

FAQ

What is Severe Cold & Flu Relief used for?

Severe Cold & Flu Relief temporarily relieves common cold and flu symptoms, including minor aches and pains, sinus congestion, sore throat, fever, headache, nasal congestion, and cough.

What are the active ingredients in Severe Cold & Flu Relief?

The active ingredients include Acetaminophen (pain reliever/fever reducer), Dextromethorphan HBr (cough suppressant), Guaifenesin (expectorant), and Phenylephrine HCl (nasal decongestant).

How should I take Severe Cold & Flu Relief?

Adults and children 12 years and over should take 2 caplets with water every 4 hours, not exceeding 8 caplets in 24 hours. Children under 12 years should ask a doctor.

Are there any warnings associated with Severe Cold & Flu Relief?

Yes, it contains acetaminophen, which can cause severe liver damage if taken in excess of 4,000 mg in 24 hours or with other acetaminophen-containing drugs. It may also cause severe skin reactions.

What should I do if I experience severe side effects?

Stop use and consult a doctor if you experience nervousness, dizziness, sleeplessness, or if symptoms worsen or persist beyond the recommended duration.

Can I use Severe Cold & Flu Relief if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

Who should not use Severe Cold & Flu Relief?

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

How should I store Severe Cold & Flu Relief?

Store at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F). Ensure the outer package is unopened and the blister is intact.

Packaging Info

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

Packaging configurations for Cold and Flu Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation contains acetaminophen, a pain reliever and fever reducer; dextromethorphan hydrobromide, a cough suppressant; guaifenesin, an expectorant; and phenylephrine hydrochloride, a nasal decongestant. The product is presented in the form of 24 caplets. The packaging is tamper-evident, and it is advised not to use the product if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, sinus congestion and pressure, sore throat, fever, headache, nasal congestion, and cough due to minor throat and bronchial irritation.

Additionally, this drug reduces swelling of the nasal passages and temporarily restores freer breathing through the nose. It promotes nasal and/or sinus drainage and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the maximum daily limit. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum of 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should verify with a healthcare professional if their prescription includes an MAOI.

  • History of allergic reaction to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken for patients with the following conditions: liver disease, thyroid disease, diabetes, heart disease, high blood pressure, difficulty urinating due to prostate gland enlargement, or a cough associated with excessive phlegm. Additionally, patients with persistent or chronic coughs, such as those related to smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before use. It is also recommended that patients taking the anticoagulant warfarin consult with a healthcare provider or pharmacist prior to use.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients are advised to discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough 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 expected, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include blisters, rash, and skin reddening. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Participants should stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than seven days, fever that worsens or lasts more than three days, redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs alongside a rash or headache lasting for an extended period. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with other products 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 the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe and effective use.

Packaging & NDC

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

Packaging configurations for Cold and Flu Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum limit of 8 caplets within a 24-hour period. Caution is advised to ensure adherence to the dosing guidelines to prevent potential overdose.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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, particularly if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before initiating treatment, as liver function may influence renal clearance and overall drug metabolism. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, especially when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or 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 about the presence of acetaminophen in their medications, they should be encouraged to consult 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 stopped taking an MAOI within the past two weeks. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should also inform patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should be advised to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists for more than seven days. Additionally, they should be instructed to contact a healthcare professional if fever worsens or lasts longer than three days, or if they notice any redness or swelling. New symptoms that arise should also prompt a consultation with a doctor.

Patients should be made aware that if their 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 emphasize that patients must not exceed the recommended dosage while using this product.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, thyroid disease, diabetes, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a cough associated with excessive phlegm. Patients with a persistent or chronic cough, such as those caused by smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Finally, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). For proper handling, it is essential to check the end flap for the expiration date and lot number to ensure product integrity and safety.

Additional Clinical Information

No additional information is available regarding laboratory tests or postmarketing experience.

Patients aged 12 years and older are advised to take 2 caplets orally with water every 4 hours, while those under 12 years should consult a doctor for appropriate dosing. Clinicians should counsel patients to seek professional advice if they are pregnant or breastfeeding. Additionally, information on the potential for medicine abuse among teens can be found at www.StopMedicineAbuse.org.

Drug Information (PDF)

This file contains official product information for Cold and Flu Relief, 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 Cold and Flu Relief, 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.

Learn more in our Editorial Policy

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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.