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Medi-First Cough Cold, Medi-First Plus Cough Cold, Medique Decorel Forte

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Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 100 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 2022
Label revision date
September 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 100 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 2022
Label revision date
September 8, 2025
Manufacturer
Unifirst First Aid Corporation
Registration number
M012
NDC roots
47682-435, 47682-835, 47682-836
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (8 NDCs)
Packaging & NDC Codes (8)

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

Medi-First® is a medication designed to provide relief from cough and cold symptoms. It contains several active ingredients that work together to help you feel better when you're suffering from a cold. Acetaminophen (325 mg) helps reduce fever and relieve minor aches and pains, while Dextromethorphan HBr (10 mg) is effective in suppressing coughs. Guaifenesin (100 mg) helps loosen phlegm (mucus) and thins bronchial secretions, making it easier to cough up mucus, and Phenylephrine HCl (5 mg) alleviates nasal congestion.

This medication temporarily relieves a variety of symptoms associated with the common cold, including headache, sore throat, sinus congestion and pressure, and chest congestion. It is intended for use in households without young children and comes in tamper-evident unit dose packets for safety.

Uses

If you're dealing with the common cold, this medication can help temporarily relieve a variety of uncomfortable symptoms. You may find relief from headaches, nasal congestion, cough, minor aches and pains, sore throat, and sinus congestion and pressure. Additionally, it helps loosen phlegm (mucus) and thin bronchial secretions, making your cough more productive by clearing your bronchial tubes.

This medication also works to temporarily reduce fever, helping you feel more comfortable while your body fights off the cold.

Dosage and Administration

When taking this medication, it’s important to follow the directions carefully. For adults and children aged 12 years and older, you should take 2 caplets by mouth every 4 hours. However, make sure not to exceed 10 caplets in a 24-hour period. If you are giving this medication to a child under 12 years old, it’s best to consult a doctor first to determine the appropriate dosage.

Always remember to take the caplets orally, and stick to the recommended timing to ensure safe and effective use. If you have any questions or concerns about how to take this medication, don’t hesitate to reach out to a healthcare professional for guidance.

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, it's best to consult with your doctor or pharmacist. Additionally, do not use this product if you have ever had an allergic reaction to it or any of its ingredients. If you are taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication used for depression or certain psychiatric conditions—or have stopped taking one within the last two weeks, you should also avoid this product.

It's important to follow the recommended dosage and not exceed it while using this product. Always seek guidance from a healthcare professional if you have any questions or concerns about your medications.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It 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. 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 seek medical advice if you experience nervousness, dizziness, or sleeplessness, if your pain, cough, or nasal congestion worsens or lasts more than seven days, or if you notice any new symptoms. 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 a 24-hour period, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as blisters, rash, or skin reddening. If you experience any skin reactions, stop using the product and seek medical help immediately. Additionally, if you have a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

In case of an overdose, it is crucial to get emergency medical help or contact a Poison Control Center right away, even if you do not notice any symptoms. You should also stop taking the product and call your doctor if you experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or lasts more than seven days; if fever worsens or lasts more than three days; if you notice redness or swelling; if new symptoms develop; or if a cough returns with a rash or headache that lasts.

Overdose

Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. If you think you or someone else may have taken too much acetaminophen, it’s important to seek emergency medical help right away.

Signs of an overdose can include nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). If you notice any of these symptoms or suspect an overdose, don’t hesitate to get medical assistance immediately. Your health and safety are the top priority.

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, both adults and children can take 2 caplets every 4 hours, but it's crucial not to exceed 10 caplets in a 24-hour period. Always follow these guidelines to ensure safe and effective use.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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. Additionally, you should avoid using other medications that also contain acetaminophen while taking this product, as this can increase your risk of harm.

If you consume three or more alcoholic drinks each day, you should be especially careful, as this can further increase the risk of liver damage when using acetaminophen. Always consult with your healthcare provider for personalized advice and to ensure your safety while using this medication.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining it with acetaminophen could increase your risk of bleeding, which is a serious concern.

Always discuss any medications you are currently taking with your healthcare provider to ensure your safety and avoid potential interactions. Your health is a priority, and your provider can help you navigate any risks.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, specifically at 25°C (77°F). It’s acceptable for the temperature to vary between 15°C and 30°C (59°F to 86°F) occasionally. Always check that the packets are sealed properly; they should be tamper-evident, meaning you can see if they have been opened or altered. If you find any packets that are opened or torn, do not use them, as this could compromise the product's safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is Medi-First® used for?

Medi-First® is used for cough and cold relief, temporarily relieving symptoms such as headache, nasal congestion, cough, minor aches and pains, sore throat, and sinus congestion.

What are the active ingredients in Medi-First®?

Medi-First® contains acetaminophen (325 mg) for aches and fever, dextromethorphan HBr (10 mg) for coughs, guaifenesin (100 mg) for chest congestion, and phenylephrine HCl (5 mg) for nasal congestion.

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

Adults and children 12 years and over should take 2 caplets every 4 hours, not exceeding 10 caplets in 24 hours.

Are there any contraindications for using Medi-First®?

Do not use Medi-First® with any other drug containing acetaminophen, if you have had an allergic reaction to it, or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

What should I do if I experience severe side effects?

If you experience nervousness, dizziness, sleeplessness, or if symptoms worsen or new symptoms occur, stop using the product and consult a doctor.

Is it safe to use Medi-First® during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Medi-First®.

What should I do in case of an overdose?

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

How should I store Medi-First®?

Store Medi-First® at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F), and ensure packets are tamper evident and not opened or torn.

Packaging Info

Below are the non-prescription pack sizes of Medi-First Cough Cold, Medi-First Plus Cough Cold, Medique Decorel Forte (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Medi-First Cough Cold, Medi-First Plus Cough Cold, Medique Decorel Forte.
Details

Drug Information (PDF)

This file contains official product information for Medi-First Cough Cold, Medi-First Plus Cough Cold, Medique Decorel Forte, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including headache, nasal congestion, cough, minor aches and pains, sore throat, and sinus congestion and pressure. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing cough productivity. This drug also temporarily reduces fever.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets taken orally every 4 hours, with a maximum limit of 10 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.

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

  • 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, due to the potential for serious drug interactions. If there is uncertainty about the presence of an MAOI in a current prescription, a healthcare professional should be consulted.

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. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as well as in patients who consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include blisters, rash, and skin reddening. In the event of a skin reaction, patients should 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 healthcare provider promptly.

In the event of an overdose, it is critical to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or occurs alongside a rash or headache that lasts should also prompt a consultation with a healthcare professional.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are advised that liver damage may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Allergic reactions may also occur, with acetaminophen potentially causing severe skin reactions. Symptoms of such reactions can include blisters, rash, and skin reddening. Should any of these symptoms manifest, patients are instructed to discontinue use immediately and seek medical assistance.

In addition, patients should be vigilant for signs of a severe sore throat. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Patients are advised to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, cough, or nasal congestion lasting more than seven days; fever that worsens or lasts more than three days; presence of redness or swelling; the emergence of new symptoms; or a cough that recurs or occurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using acetaminophen. The combination may elevate the risk of bleeding due to potential interactions between these medications. Monitoring of coagulation parameters is advisable to ensure patient safety and to adjust dosages as necessary.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Medi-First Cough Cold, Medi-First Plus Cough Cold, Medique Decorel Forte (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Medi-First Cough Cold, Medi-First Plus Cough Cold, Medique Decorel Forte.
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 every 4 hours, with a maximum of 10 caplets in a 24-hour period.

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.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the potential for adverse effects in this population. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In cases of acetaminophen overdosage, severe liver damage may occur if an individual ingests more than 4,000 mg within a 24-hour period. This threshold is critical, as exceeding it significantly increases the risk of hepatotoxicity.

Healthcare professionals are advised to seek emergency medical assistance immediately if an acetaminophen overdose is suspected. Prompt intervention is essential to mitigate potential complications and to initiate appropriate management strategies.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

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

It is essential to inform patients that they should not use this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease should avoid this product, as well as for two weeks after discontinuing the MAOI. Patients should be encouraged to ask a doctor or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, cough, or nasal congestion worsens or persists beyond seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms or a cough that returns or occurs with a rash or headache that lasts should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, patients must not exceed the recommended dosage. It is advisable for patients to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also seek medical advice if they have a cough accompanied by excessive phlegm or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in tamper-evident sealed packets. It is essential to store the packets at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F).

Healthcare professionals are advised to refrain from using any packets that are opened or torn, as this may compromise the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Medi-First Cough Cold, Medi-First Plus Cough Cold, Medique Decorel Forte, 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 Medi-First Cough Cold, Medi-First Plus Cough Cold, Medique Decorel Forte, 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.