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Acetaminophen/Chlorpheniramine maleate/Phenylephrine hydrochloride

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Active ingredients
  • Chlorpheniramine Maleate 2 mg
  • Acetaminophen 325 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
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 2010
Label revision date
November 29, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Chlorpheniramine Maleate 2 mg
  • Acetaminophen 325 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
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 2010
Label revision date
November 29, 2022
Manufacturer
Contract Pharmacal Corp.
NDC root
10267-2634
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

I'm sorry, but it seems that the information provided does not include any specific details about a drug's name, its uses, or its mechanism of action. Without these critical facts, I cannot create a summary that accurately describes what the drug is or what it is used for. If you have more detailed information about the drug, please share it, and I would be happy to help!

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. The recommended dosage includes 325 mg of acetaminophen, which is a common pain reliever and fever reducer. Additionally, it contains 2 mg of chlorpheniramine maleate, an antihistamine that helps relieve allergy symptoms, and 5 mg of phenylephrine hydrochloride, which is a decongestant that helps clear nasal passages.

Make sure to follow the dosage instructions carefully to ensure the medication works effectively. If you have any questions about how to take it or if it’s right for you, don’t hesitate to ask your healthcare provider for guidance.

What to Avoid

It seems that the provided information does not specify any particular contraindications, controlled substance details, risks of abuse or misuse, or concerns about dependence. Additionally, there are no explicit instructions on what you should not take or use.

If you have any specific questions or need guidance on a particular medication or health concern, please consult your healthcare provider for personalized advice and information. They can help ensure your safety and well-being.

Side Effects

You may experience some common side effects, including drowsiness, dizziness, dry mouth, nausea, and vomiting. It's important to be aware of more serious reactions as well. These can include allergic reactions, which may present as a rash, itching, swelling, severe dizziness, or trouble breathing. Additionally, high doses of acetaminophen can lead to liver damage, so it's crucial to use this medication carefully, especially if you have liver disease.

If you have hypertension, be mindful that phenylephrine can raise your blood pressure. Chlorpheniramine may cause sedation, so exercise caution when operating machinery or driving. Always consult with your healthcare provider if you have concerns about these side effects.

Warnings and Precautions

While there are no specific warnings or precautions listed for this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or reactions while taking this medication, it’s wise to stop using it and consult your doctor for guidance.

Additionally, if you have any concerns or questions about your treatment, don’t hesitate to reach out to your healthcare provider. They can provide you with the necessary information and support to ensure your safety and well-being.

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 or contact a Poison Control Center right away. Acting quickly can make a significant difference in treatment and recovery.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. In fact, its use is generally not recommended because it may pose potential risks to your developing baby. Always consult your healthcare provider for personalized advice and to discuss any concerns you may have.

If you do need to use this medication, your doctor may suggest dosage adjustments tailored to your situation. It's crucial to only use this medication if it is clearly necessary and after a thorough discussion with your healthcare provider about the potential risks and benefits.

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 best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If you are considering this medication for your child, it's important to know that it has not been tested for safety and effectiveness in children under 12 years old. Therefore, you should consult a physician (a medical doctor) before giving it to any child in this age group. Always prioritize your child's health by seeking professional advice to ensure their safety.

Geriatric Use

As you age, your body may respond differently to medications, including acetaminophen, phenylephrine hydrochloride, and chlorpheniramine maleate. Older adults often have increased sensitivity to the side effects of these drugs, which means you might experience more pronounced effects than younger individuals. It's important to be aware that dosage adjustments may be necessary, especially if you have reduced kidney function, a common concern in older adults.

When considering this medication, special precautions should be taken. Your overall health status and any other medical conditions you may have (known as comorbidities) should be carefully evaluated. Always consult with your healthcare provider to ensure that the medication is safe and appropriate for your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe for your liver health. They can help determine the best approach for your treatment based on your individual circumstances.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light and always keep it in a tightly closed container to maintain its quality.

Once you open the container, remember to discard any remaining product, as it should not be reused. Following these guidelines will help you handle the product safely and effectively.

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 for the active ingredients in this medication?

The dosages are 325 mg of Acetaminophen, 2 mg of Chlorpheniramine Maleate, and 5 mg of Phenylephrine Hydrochloride.

What are common adverse reactions to this medication?

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

What serious side effects should I be aware of?

Serious side effects may include allergic reactions and liver damage, especially with high doses of acetaminophen.

Are there any precautions for elderly patients?

Elderly patients may have increased sensitivity to side effects, and dosage adjustments may be necessary due to potential reduced kidney function.

Is this medication safe to use during pregnancy?

The safety of this medication during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What should I do if I experience an allergic reaction?

If you experience symptoms like rash, itching, swelling, severe dizziness, or trouble breathing, seek emergency medical help immediately.

How should I store this medication?

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

What should I do if I am considering this medication for a child under 12?

Consult a physician before using this medication for children under 12 years of age, as safety and effectiveness have not been established.

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 drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with the letter "A" on one side and the number "1" on the opposite side. Each tablet contains 1 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and color additives.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the overall clinical context when prescribing this medication.

Dosage and Administration

The recommended route of administration is oral.

For the combination product, the following dosages are advised:

  • Acetaminophen: 325 mg

  • Chlorpheniramine Maleate: 2 mg

  • Phenylephrine Hydrochloride: 5 mg

Healthcare professionals should ensure that the patient adheres to the prescribed dosage and frequency as indicated in the treatment plan. It is essential to monitor the patient's response to therapy and adjust the dosage as necessary, based on clinical judgment and individual patient needs.

Contraindications

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

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this medication. Additionally, no laboratory tests are required or suggested for safe use. Healthcare professionals should remain vigilant and monitor patients as necessary, although no specific monitoring parameters have been outlined.

In the event of any adverse reactions or concerns, it is advisable for patients to seek emergency medical assistance. Furthermore, if any unexpected symptoms arise, patients should discontinue use and consult their healthcare provider for further guidance.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Common adverse reactions reported include drowsiness, dizziness, dry mouth, nausea, and vomiting. These effects are generally mild but can impact daily activities.

Serious side effects have also been observed. Patients may experience allergic reactions, which can manifest as rash, itching, swelling, severe dizziness, or difficulty breathing. Additionally, there is a risk of liver damage associated with high doses of acetaminophen, necessitating careful monitoring of dosage.

It is important to use this medication with caution in patients with pre-existing liver disease, as acetaminophen can exacerbate liver issues. Furthermore, phenylephrine may lead to increased blood pressure; therefore, patients with hypertension should be monitored closely. Chlorpheniramine is known to cause sedation, and patients are advised to exercise caution when operating machinery or driving.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

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 established for children under 12 years of age. The safety and effectiveness of this product in pediatric patients have not been determined. It is recommended that a physician be consulted prior to use in this age group.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of acetaminophen, phenylephrine hydrochloride, and chlorpheniramine maleate. This heightened sensitivity necessitates careful monitoring and consideration of potential adverse effects when prescribing these medications.

Dosage adjustments may be required for geriatric patients, particularly due to the potential for reduced kidney function commonly observed in this population. It is essential for healthcare providers to assess renal function and adjust dosages accordingly to mitigate the risk of toxicity.

Additionally, special precautions should be taken when administering this medication to elderly patients. Consideration of their overall health status and the presence of comorbidities is crucial in ensuring safe and effective treatment. Regular monitoring and evaluation of the patient's response to therapy are recommended to optimize outcomes in this vulnerable population.

Pregnancy

Safety during pregnancy has not been established for this medication. Its use is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of this medication during pregnancy; therefore, it is essential for healthcare providers to be consulted for advice regarding its use.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare provider. Pregnant women should use this medication only if clearly needed and after thorough discussion with their healthcare provider to weigh the potential benefits against the risks.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

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 have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

Overdosage of acetaminophen can lead to significant hepatic injury. Healthcare professionals should be vigilant for symptoms indicative of overdose, which may manifest as nausea, vomiting, loss of appetite, confusion, and jaundice, characterized by a yellowing of the skin or eyes.

In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center without delay for further guidance and management. Prompt intervention is crucial to mitigate the risk of severe liver damage associated with acetaminophen overdosage.

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 limits the assessment of potential risks associated with the compound in these areas.

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 take this medication exactly as directed and not to exceed the recommended dosage, as doing so may lead to adverse effects.

Patients should be informed that this product may cause drowsiness. Therefore, they should avoid driving or operating heavy machinery until they are aware of how the medication affects them. Additionally, patients should be cautioned against consuming alcohol while taking this medication, as it may increase the risk of liver damage.

Healthcare providers should encourage patients to consult a healthcare professional if their symptoms do not improve within a few days or if they experience any adverse effects. Furthermore, patients should be informed to keep this medication out of reach of children and to seek medical help immediately in the event of an overdose.

Storage and Handling

The product is supplied in a tightly closed container to ensure integrity and stability. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its efficacy. Once opened, the product must be discarded to ensure safety and effectiveness.

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.