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Medique at Home 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 2026
Label revision date
March 3, 2026
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 2026
Label revision date
March 3, 2026
Manufacturer
Sportpharm LLC
Registration number
M012
NDC root
85766-174
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

This medication is designed to temporarily relieve symptoms associated with the common cold, such as headache, nasal congestion, cough, minor aches and pains, sore throat, and sinus congestion and pressure. It also helps to loosen phlegm (mucus) and thin bronchial secretions, making your cough more productive. Additionally, this drug can temporarily reduce fever, providing you with some comfort during your illness.

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.

This medication also works to temporarily reduce fever, helping you feel more comfortable as you recover.

Dosage and Administration

When using this medication, it's important to follow the dosage instructions carefully. For adults and children aged 12 years and older, you should take 2 caplets 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 for the appropriate dosage.

You will take the caplets by mouth, ensuring you stick to the recommended timing. Remember, never take more than directed to avoid any potential risks. Always keep track of how many caplets you've taken to stay within the safe limits.

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. Additionally, do not use it if you have ever had an allergic reaction to this product or any of its ingredients. If you are taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson’s disease, you must not use this product while on the MAOI or for two weeks after stopping it.

It's also important to follow the recommended dosage and not exceed it, as doing so can lead to serious health risks. Always prioritize your safety and consult with a healthcare professional if you have any questions or concerns about using this product.

Side Effects

Taking this product may lead to some serious side effects. It contains acetaminophen, which can cause severe liver damage if you exceed 4,000 mg in a 24-hour period, take it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it.

Additionally, be aware that acetaminophen can trigger severe skin reactions, which may include blisters, rash, or skin reddening. If you notice any of these symptoms, stop using the product and seek medical help immediately. If you experience a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor right away.

Warnings and Precautions

It's important to be aware of some key warnings when using this product, which contains acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period, using it alongside other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage. Additionally, be cautious of potential severe skin reactions, which may include blisters, rash, or skin reddening. 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 two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it's important to consult a doctor promptly. In case of an accidental overdose, seek emergency medical help or contact a Poison Control Center right away, as quick medical attention is crucial for both adults and children, even if no symptoms are present.

Overdose

Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. It's important to be cautious and avoid using any other medications that also contain acetaminophen, whether they are prescription or over-the-counter, as this can increase your risk of an overdose.

If you suspect an overdose, look out for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). If you experience any of these symptoms or believe you have taken too much acetaminophen, seek immediate medical help. Your health and safety are the top priority, so don’t hesitate to reach out to a healthcare professional.

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 your child is under 12 years old, it's important to consult with a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 2 caplets every 4 hours, but be sure not to exceed 10 caplets in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

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 may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney issues, 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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, combining this product with other medications that also contain acetaminophen can increase your risk.

You should also be aware that consuming three or more alcoholic drinks each day while using acetaminophen can further harm your liver. Always consult with your healthcare provider for personalized advice and to ensure your safety when using medications.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally around 25°C (77°F). It’s acceptable for the temperature to vary between 15°-30°C (59°-86°F), but try to keep it within this range. The product comes in tamper-evident, child-resistant packets, which means they are designed to be safe and secure.

Always check the packets before use; do not use any that are opened or torn, as this could compromise the product's integrity. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What symptoms does this drug relieve?

This drug temporarily relieves symptoms due to the common cold, including headache, nasal congestion, cough, minor aches and pains, sore throat, and sinus congestion and pressure.

How does this drug help with cough?

It helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes, making your cough more productive.

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.

What should children under 12 do?

Children under 12 years should ask a doctor before use.

Are there any liver warnings associated with this drug?

Yes, severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours, use with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

What should I do if I experience a skin reaction?

If you experience a skin reaction such as blisters, rash, or skin reddening, stop use and seek medical help right away.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

What should I do in case of an accidental overdose?

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Can I take this drug with other medications?

Do not use this drug with any other medication containing acetaminophen or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

Packaging Info

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

Packaging configurations for Medique at Home Decorel Forte.
Details

Drug Information (PDF)

This file contains official product information for Medique at Home 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 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:

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

This product is contraindicated in individuals with a known allergy to it or any of its ingredients, as this may lead to severe allergic reactions.

Additionally, the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious drug interactions.

Exceeding the recommended dosage is also contraindicated, as it may result in adverse effects.

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 this can increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Acetaminophen has been associated with severe skin reactions, which may manifest as blisters, rash, or skin reddening. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should also be vigilant regarding patients presenting with a severe sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is essential.

In cases of accidental overdose, immediate medical attention is critical. Patients should be advised to contact a Poison Control Center or seek emergency medical help right away, regardless of whether they exhibit any signs or symptoms of overdose.

If any skin reactions occur, patients must stop taking the product and contact their healthcare provider immediately for further evaluation and management.

Side Effects

Patients using this product should be aware of several important warnings regarding 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.

Furthermore, a sore throat warning is in place; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Medique at Home 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. 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 potential 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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

Acetaminophen overdose can lead to severe liver damage, particularly when the total daily intake exceeds 4,000 mg within a 24-hour period. Healthcare professionals should be vigilant in monitoring patients for signs of overdose, especially in those who may inadvertently exceed this threshold.

It is critical to advise patients against the concurrent use of any other medications containing acetaminophen, whether prescription or nonprescription. This precaution is essential to mitigate the risk of overdose and its associated complications.

In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should assess the patient's clinical status and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are also key components of management.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, including blisters, rash, and skin reddening. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential 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 that contains 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 for clarification.

It is important to instruct patients not to use this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, patients should be cautioned against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If patients are unsure whether their prescription medication includes an MAOI, they should be advised to consult a healthcare professional.

Patients must be reminded to adhere to the recommended dosage and not to exceed it while using this product. Furthermore, healthcare providers should encourage patients to seek medical advice before using this medication if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate enlargement, or a cough associated with excessive phlegm or chronic conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Lastly, patients taking the blood-thinning medication warfarin should be advised to consult with a doctor or pharmacist before using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in tamper-evident, child-resistant 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 ensure that any opened or torn packets are not used, 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 Medique at Home 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 Medique at Home 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.