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Acetaminophen/Phenylephrine hydrochloride/Chlorpheniramine maleate

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Active ingredients
  • Chlorpheniramine Maleate 4 mg/17000 mg
  • Acetaminophen 650 mg/17000 mg
  • Phenylephrine Hydrochloride 10 mg/17000 mg
Other brand names
Dosage form
Powder, for Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
April 2, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Chlorpheniramine Maleate 4 mg/17000 mg
  • Acetaminophen 650 mg/17000 mg
  • Phenylephrine Hydrochloride 10 mg/17000 mg
Other brand names
Dosage form
Powder, for Solution
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 2015
Label revision date
April 2, 2020
Manufacturer
Contract Pharmacal Corp.
NDC root
10267-2657
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

It seems that the information provided does not include specific details about the drug's name, its general description, or its mechanism of action. Without these key facts, I am unable to create a summary that accurately describes what the drug is and its purpose. If you have more detailed information about the drug, please share it, and I would be happy to help you craft a consumer-friendly summary.

Uses

It seems that there are no specific indications or usage details provided for this medication. This means that the information about what this drug is used for is not available at this time. If you have any questions or need further clarification about this medication, it's best to consult with your healthcare provider for more personalized information. They can provide guidance based on your individual health needs.

Dosage and Administration

When taking this medication, you will be using it orally, which means you will swallow it. Each dose contains specific amounts of active ingredients: 650 mg of acetaminophen (a pain reliever and fever reducer), 10 mg of phenylephrine hydrochloride (a decongestant that helps relieve nasal congestion), and 4 mg of chlorpheniramine maleate (an antihistamine that helps with allergy symptoms).

It's important to follow the recommended dosage carefully to ensure safety and effectiveness. Always check the packaging for specific instructions on how often to take the medication, and consult with your healthcare provider if you have any questions or concerns about its use.

What to Avoid

It's important to be aware of certain precautions when considering this medication. While specific contraindications (conditions that would make the use of the medication inadvisable) and details about controlled substance classification are not provided, you should always consult with your healthcare provider to ensure it's safe for you.

Additionally, be mindful of the potential for abuse or misuse, which refers to using the medication in a way not intended by your doctor. This can lead to dependence (a condition where your body becomes reliant on the medication). Always follow your healthcare provider's instructions and do not take or use this medication without their guidance. If you have any concerns or questions, don't hesitate to reach out to your healthcare professional for more information.

Side Effects

You may experience some common side effects while taking this medication, including nausea, vomiting, dizziness, drowsiness, dry mouth, and constipation. It's important to be aware of more serious reactions as well. These can include allergic reactions, which may manifest as a rash, itching, swelling, severe dizziness, or trouble breathing. Additionally, signs of liver damage, such as jaundice (yellowing of the skin or eyes), dark urine, or severe abdominal pain, should be monitored closely.

There are also rare but serious conditions that have been reported, such as anaphylaxis (a severe allergic reaction), Stevens-Johnson syndrome, and toxic epidermal necrolysis. Other potential issues include liver toxicity, kidney problems, cardiovascular events like high blood pressure or irregular heartbeats, and neurological events such as seizures. Please remember that there is a boxed warning regarding the risk of severe liver injury, especially if you take too much of this medication or use it alongside other products containing acetaminophen.

Warnings and Precautions

It seems that the specific warnings, precautions, and instructions for emergency help or stopping use are not provided in the information available. However, it's important to always be aware of potential side effects and to communicate openly with your healthcare provider about any concerns you may have regarding your medication.

If you experience any unusual symptoms or reactions while taking your medication, it’s crucial to stop using it and contact your doctor immediately. They can provide guidance tailored to your situation. Additionally, regular check-ups and lab tests may be necessary to monitor your health while on certain medications, so be sure to follow your doctor's recommendations. Always prioritize your health and safety by staying informed and proactive in your care.

Overdose

Taking too much acetaminophen can lead to serious liver damage. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea, vomiting, loss of appetite, confusion, and jaundice (a yellowing of the skin or eyes).

If you suspect an overdose, seek immediate medical attention. Quick action can make a significant difference in treatment and recovery. Always remember that it's better to be safe and get help if you have any concerns about acetaminophen use.

Pregnancy Use

It is important to be cautious if you are pregnant or planning to become pregnant. The safety of this medication during pregnancy has not been established, meaning that it has not been proven safe for use. In fact, this product is contraindicated in pregnancy, which means it should not be used at all while you are pregnant. There may also be potential risks to the fetus (the developing baby) associated with using this medication during pregnancy.

If you are pregnant or considering pregnancy, it is essential to discuss any medications with your healthcare provider to ensure the safety of both you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to note that the information provided does not specifically address the use of this medication in children. There are no recommended ages, dosage differences, or safety concerns outlined for pediatric use (which refers to the treatment of infants, children, and adolescents).

If you are considering this medication for a child, it is essential to consult with a healthcare professional for guidance tailored to their specific needs and circumstances. Always prioritize their safety and well-being by seeking expert advice.

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 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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 share your complete list of medications and any lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed to maintain its integrity and protect it from light exposure, which can affect its quality.

After opening, remember to discard any unused portion to avoid contamination and ensure safety. Following these simple guidelines will help you use the product effectively and safely.

Additional Information

No further information is available.

FAQ

What is the route of administration for this medication?

The medication is administered orally.

What are the dosages of the active ingredients in this medication?

The medication contains 650 mg of Acetaminophen, 10 mg of Phenylephrine Hydrochloride, and 4 mg of Chlorpheniramine Maleate.

What are some common adverse reactions to this medication?

Common adverse reactions include nausea, vomiting, dizziness, drowsiness, dry mouth, and constipation.

What serious adverse reactions should I be aware of?

Serious adverse reactions may include allergic reactions, liver damage, anaphylaxis, and Stevens-Johnson syndrome.

What is the boxed warning associated with this medication?

There is a risk of severe liver injury with overdose or use of multiple acetaminophen-containing products.

Is this medication safe to use during pregnancy?

The safety of this medication during pregnancy has not been established, and it is contraindicated in pregnancy.

How should I store this medication?

Store the medication at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.

Packaging Info

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

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

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no specific indications or usage details provided.

Healthcare professionals should be aware that there are no documented teratogenic or nonteratogenic effects associated with this drug. Further research may be necessary to establish comprehensive indications and usage parameters.

Dosage and Administration

The medication is administered orally. The recommended dosage for the formulation includes the following components:

  • Acetaminophen: 650 mg per 17,000 mg of the total formulation.

  • Phenylephrine Hydrochloride: 10 mg per 17,000 mg of the total formulation.

  • Chlorpheniramine Maleate: 4 mg per 17,000 mg of the total formulation.

Healthcare professionals should ensure that the total dosage does not exceed the specified amounts for each active ingredient. It is essential to follow the prescribed dosing regimen and to monitor the patient for any adverse effects associated with the administration of this medication.

Contraindications

There are no specific contraindications listed for this product. Healthcare professionals should exercise clinical judgment when considering its use in patients with potential risk factors or underlying conditions.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

It is imperative to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular assessments and laboratory tests should be conducted as clinically indicated to ensure patient safety and therapeutic efficacy.

In the event of severe side effects or unexpected reactions, immediate medical attention should be sought. Healthcare providers are advised to instruct patients to discontinue use and contact their physician if they experience any concerning symptoms.

Due diligence in patient monitoring and communication is essential to mitigate risks and enhance treatment outcomes.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Common adverse reactions reported include nausea, vomiting, dizziness, drowsiness, dry mouth, and constipation. These reactions are generally mild and may resolve with continued use or upon discontinuation of the medication.

Serious adverse reactions have also been observed. Patients may experience allergic reactions, which can manifest as rash, itching, swelling, severe dizziness, or trouble breathing. Additionally, liver damage is a significant concern, with symptoms such as jaundice, dark urine, and severe abdominal pain indicating potential hepatic injury.

In the postmarketing experience, several serious adverse reactions have been reported, including anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Other notable events include hepatotoxicity, renal impairment, cardiovascular events such as hypertension and arrhythmias, and neurological events, including seizures.

It is important to note the boxed warning regarding the risk of severe liver injury associated with overdose or the concurrent use of multiple acetaminophen-containing products. This risk underscores the necessity for careful monitoring and adherence to dosing guidelines to mitigate potential harm.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

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

Pediatric Use

Pediatric use is not specifically addressed in the provided information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the lack of specific data.

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 potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Safety during pregnancy has not been established for this medication. It is contraindicated in pregnant patients due to potential risks to the fetus associated with its use. Healthcare professionals should be aware of these risks when considering treatment options for women of childbearing potential. It is essential to weigh the benefits against the potential fetal impacts before prescribing this medication to pregnant patients.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk are not established. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of acetaminophen is associated with the potential for significant liver damage. Healthcare professionals should be vigilant in recognizing the symptoms that may arise following an overdose. These symptoms can include nausea, vomiting, loss of appetite, confusion, and jaundice, which is characterized by a yellowing of the skin or eyes.

In the event of an acetaminophen overdose, it is imperative to seek immediate medical attention. Prompt intervention is crucial to mitigate the risk of severe liver injury and to initiate appropriate management strategies.

Nonclinical Toxicology

No teratogenic effects were noted in animal studies. Additionally, there was no increase in fetal malformations observed in these studies.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to read the Drug Facts label thoroughly before using this product to ensure proper understanding of its contents and instructions. It is important for patients to use the product only as directed, as misuse can lead to serious health risks.

Healthcare providers should inform patients that exceeding the recommended dose may result in significant harm. Patients should be encouraged to consult a healthcare professional if their symptoms do not improve within a few days or if they experience any worsening of their condition.

Additionally, patients should be cautioned against using this product in conjunction with other medications that contain acetaminophen, as this could lead to an overdose. It is also essential to inform patients to avoid alcohol consumption while taking this product, as it may increase the risk of adverse effects.

Healthcare providers should emphasize the importance of keeping this product out of reach of children. In the event of an overdose, patients should be advised to seek medical help or contact a Poison Control Center immediately.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at room temperature, within the range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. Any unused portion should be discarded after opening to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

Last AI update:

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.