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Acetaminophen/Chlorpheniramine maleate/Phenylephrine hydrochloride

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Active ingredients
  • Chlorpheniramine Maleate 4 mg
  • Acetaminophen 500 mg
  • Phenylephrine Hydrochloride 10 mg
Other brand names
Drug classes
Histamine-1 Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet
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
March 11, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Chlorpheniramine Maleate 4 mg
  • Acetaminophen 500 mg
  • Phenylephrine Hydrochloride 10 mg
Other brand names
Drug classes
Histamine-1 Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet
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
March 11, 2022
Manufacturer
OPMX LLC
Registration number
M012
NDC root
69729-322
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Resfriol-D is a medication designed to temporarily relieve symptoms associated with hay fever or other respiratory allergies. If you're experiencing discomfort from nasal congestion, sinus pressure, a runny nose, sneezing, or itchy, watery eyes, Resfriol-D can help alleviate these symptoms.

In addition to addressing nasal and sinus issues, it also provides relief from headaches and minor aches and pains, making it a supportive option for managing allergy-related discomfort. By helping to clear nasal passages and decongest sinus openings, Resfriol-D aims to make you feel more comfortable during allergy season.

Uses

If you're dealing with hay fever or other respiratory allergies, this medication can help temporarily relieve a variety of bothersome symptoms. You may find relief from headaches, nasal congestion, sinus pressure, and a runny nose, as well as sneezing and minor aches and pains.

Additionally, it can ease other hay fever symptoms such as itching in your nose or throat, itchy and watery eyes, and help clear your nasal passages. It also works to decongest your sinus openings and passages, making it easier for you to breathe.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety. For adults and children aged 12 and older, you should take 1 tablet with a glass of water every 4 to 6 hours as needed, but make sure not to exceed 6 tablets in a 24-hour period. Remember, you should swallow the tablet whole—do not crush, chew, or dissolve it.

If you're considering this medication for a child aged 4 to 12 years, it's best to consult a doctor first. For children under 4 years old, this medication should not be used at all. Always adhere to the recommended dosage to avoid any risk of overdose.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided to use it safely and effectively.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 6 tablets in 24 hours, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

You should also consult your doctor if you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting. It's important to stop using the product and contact a healthcare professional if you feel nervous, dizzy, or have trouble sleeping, if your pain, nasal congestion, or cough worsens or lasts more than 7 days, if your fever worsens or lasts more than 3 days, or if you notice redness or swelling or develop 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 6 tablets in 24 hours, use it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as redness, blisters, or rashes. If you experience any skin reaction, stop using the product and seek medical help immediately. Additionally, if you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, avoid combining it with any other medications that contain acetaminophen. If you are unsure whether a medication contains acetaminophen, ask your doctor or pharmacist. You should also consult a healthcare professional if you have liver disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or breathing issues like emphysema or chronic bronchitis. If you are taking the blood thinner warfarin, check with your doctor or pharmacist before use. Always follow the recommended dosage and do not exceed it.

Stop using this product and call your doctor if you feel nervous, dizzy, or unable to sleep, if your pain, nasal congestion, or cough worsens or lasts more than 7 days, if your fever worsens or lasts more than 3 days, if you notice redness or swelling, or if new symptoms develop. These could indicate a serious condition that requires medical attention.

Overdose

If you suspect an overdose, it’s important to act quickly. Always read the directions carefully to avoid taking too much. If an overdose occurs, seek medical help or contact a Poison Control Center immediately. This is crucial for both adults and children, even if you don’t see any signs or symptoms of overdose.

Signs of overdose can vary, but it’s essential to be vigilant. If you notice anything unusual or have concerns, don’t hesitate to reach out for help. Remember, prompt medical attention can make a significant difference.

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

When considering this medication for your child, it's important to follow specific guidelines based on their age. For adults and children aged 12 years and older, the recommended dosage is 1 tablet taken with water every 4 to 6 hours as needed. However, if your child is between 4 and 12 years old, you should consult a doctor before giving them this medication. It is crucial to note that this medication is not safe for children under 4 years of age, so please avoid using it for younger children. Always prioritize your child's safety and seek professional advice when in doubt.

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, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

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 for patients with 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 and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, as it contains acetaminophen. Taking more than 6 tablets in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, avoid using this product alongside other medications that also contain acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using it.

Before starting this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using this medication.

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 monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain emotional conditions—or have stopped taking one within 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 room temperature, ideally between 20-25°C (68-77ºF). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Resfriol-D used for?

Resfriol-D temporarily relieves symptoms of hay fever or other respiratory allergies, including headache, nasal congestion, and runny nose.

What symptoms does Resfriol-D relieve?

It relieves headache, nasal congestion, sinus congestion and pressure, runny nose, sneezing, minor aches and pain, itching of the nose or throat, and itchy, watery eyes.

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

Adults and children 12 years of age and over should take 1 tablet with water every 4-6 hours as needed, not exceeding 6 tablets in 24 hours.

Can children use Resfriol-D?

Children aged 4 to 12 years should ask a doctor before use, and it is not recommended for children under 4 years of age.

What should I do if I experience a skin reaction?

If you notice symptoms like skin reddening, blisters, or rash, stop using Resfriol-D and seek medical help immediately.

Are there any warnings associated with Resfriol-D?

Yes, it contains acetaminophen, which can cause severe liver damage if taken in excess or with alcohol. Consult a doctor if you have liver disease or are taking blood thinners.

What should I do if my symptoms worsen?

Stop use and consult a doctor if you experience worsening pain, nasal congestion, cough lasting more than 7 days, or fever lasting more than 3 days.

Is it safe to use Resfriol-D during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Resfriol-D.

How should I store Resfriol-D?

Store Resfriol-D at room temperature between 20-25°C (68-77°F) and avoid excessive heat and humidity.

Packaging Info

Below are the non-prescription pack sizes of Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl.
Details

Drug Information (PDF)

This file contains official product information for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hay fever or other respiratory allergies. These symptoms include headache, nasal congestion, sinus congestion and pressure, runny nose, sneezing, and minor aches and pains. Additionally, it provides temporary relief from itching of the nose or throat, itchy and watery eyes, and aids in clearing nasal passages as well as decongesting sinus openings and passages.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet taken with water every 4 to 6 hours as needed. It is imperative that patients do not exceed 6 tablets within a 24-hour period.

Tablets must be swallowed whole; they should not be crushed, chewed, or dissolved to maintain the integrity of the formulation.

For children aged 4 to 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The use of this medication is not recommended for children under 4 years of age.

Patients are cautioned against exceeding the directed dosage, and they should be made aware of the overdose warning associated with this medication.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver damage increases if they exceed the maximum daily dosage of 6 tablets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, 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 healthcare provider promptly.

General Precautions

This product should not be used 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 a doctor or pharmacist. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients should be advised to confirm with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should seek medical advice before using this product if they have any of the following conditions: liver disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, it is essential to consult a doctor or pharmacist if the patient is taking the anticoagulant warfarin.

When using this product, patients must adhere strictly to the recommended dosage and not exceed the directed amount.

Stop Taking and Call Your Doctor Instructions

Patients should be instructed to discontinue use and contact a healthcare provider 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; or if new symptoms develop. These symptoms may indicate a serious condition requiring medical evaluation.

Get Emergency Medical Help Instructions

In the event of a skin reaction, patients must stop using the product immediately and seek emergency medical assistance.

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 this product, particularly if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period, take it in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Other adverse reactions that warrant discontinuation of use and consultation with a doctor include the onset of nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or lasts more than 3 days; presence of redness or swelling; or the emergence of new symptoms. These may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease, and their interaction with this medication may lead to serious adverse effects.

Additionally, 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 necessary to ensure safe use and to avoid potential bleeding complications.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 1 tablet with water every 4-6 hours as needed. For children aged 4 to 12 years, it is advised to consult a doctor before use. The medication is not recommended for children under 4 years of age.

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 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 drug 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 6 tablets within a 24-hour period. Exceeding this dosage, taking other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, regardless of whether any signs or symptoms are initially apparent.

Healthcare professionals are advised to remain vigilant and ensure that patients and caregivers are aware of the importance of following dosing instructions meticulously. In cases of suspected overdose, the absence of symptoms does not preclude the need for medical evaluation, as complications may arise unexpectedly.

Management of an overdose should be guided by clinical judgment and may involve supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is recommended to identify any potential adverse effects that may develop.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, ideally between 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl, 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 Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl, 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.