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Cold Medicine

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Active ingredients
  • Chlorpheniramine Maleate 2 mg
  • Acetaminophen 325 mg
  • Phenylephrine Hydrochloride 5 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 2022
Label revision date
October 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Chlorpheniramine Maleate 2 mg
  • Acetaminophen 325 mg
  • Phenylephrine Hydrochloride 5 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 2022
Label revision date
October 17, 2024
Manufacturer
Midway Importing, Inc.
Registration number
M012
NDC root
76095-011
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

This medication is designed to temporarily relieve various common discomforts, including minor aches and pains, headaches, nasal congestion, sinus congestion and pressure, as well as symptoms like a runny nose and sneezing. It can be particularly helpful when you're feeling under the weather or dealing with seasonal allergies, providing you with some comfort and relief from these bothersome symptoms.

Uses

You can use this medication to temporarily relieve a variety of discomforts. It helps ease minor aches and pains, making it useful when you're feeling under the weather. If you're dealing with a headache, this medication can provide quick relief as well.

In addition to pain relief, it also helps with nasal and sinus congestion, which can be particularly helpful during cold and allergy seasons. If you're experiencing a runny nose or sneezing, this medication can help alleviate those symptoms too, allowing you to feel more comfortable.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 tablets every 4 hours as needed. However, make sure not to exceed 12 tablets in a 24-hour period to avoid potential health risks.

For children under 12 years of age, it is important not to use this medication, as it can lead to an overdose, which may cause serious liver damage. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this medication if you are allergic to acetaminophen or if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions. Additionally, do not take this medication if you are using any other products that contain acetaminophen, whether they are prescription or over-the-counter.

It's important to follow the dosage instructions carefully and not exceed the recommended amount. Also, please avoid consuming alcoholic drinks while using this medication, as it can increase the risk of side effects.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 12 tablets in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, including redness, blisters, or rashes. If you notice any skin reactions, stop using the product and seek medical help immediately.

You should also stop using this product and consult a doctor if you experience redness or swelling, new symptoms, nervousness, dizziness, sleeplessness, worsening pain or nasal congestion lasting more than seven days, or a fever that worsens or lasts more than three days. It's important to talk to your doctor before using this product if you have liver disease, heart disease, glaucoma, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or breathing issues like emphysema or chronic bronchitis. Additionally, consult a doctor or pharmacist if you are taking blood thinners like warfarin or sedatives.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 12 tablets in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rashes. If you notice any skin reactions, stop using the product and seek medical help immediately.

In case of an overdose, it’s crucial to get emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 right away, even if you don’t see any symptoms. You should also stop taking the medication and call your doctor if you experience redness or swelling, new symptoms, increased nervousness, dizziness, or sleeplessness, worsening pain or nasal congestion lasting more than seven days, or a fever that worsens or lasts more than three days.

Overdose

Taking more than 12 tablets of this product in a 24-hour period can lead to severe liver damage. It's also important to be cautious if you are using other medications that contain acetaminophen, as combining them can increase the risk of liver harm. Additionally, consuming three or more alcoholic drinks daily while using this product can also result in serious liver issues.

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, seek immediate medical help. It's always better to be safe and get checked by 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

It's important to be cautious when considering this medication for children. If your child is under 12 years old, you should not use this medication, as it can lead to an overdose and potentially cause liver damage. For children aged 12 and older, the recommended dosage is 2 tablets every 4 hours, but make sure they do not exceed 12 tablets in a 24-hour period.

Additionally, be aware that some children may experience excitability as a side effect. Always consult with a healthcare professional if you have any concerns about using this medication for 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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your 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 12 tablets in a 24-hour period can lead to severe liver damage. This maximum daily amount applies even if you are using other medications that also contain acetaminophen. Additionally, consuming three or more alcoholic drinks each day while using this product can further increase the risk of liver damage.

To protect your liver, always follow the recommended dosage and avoid mixing acetaminophen with other medications that contain it. If you have any concerns about your liver health or how to safely use this product, please consult your healthcare provider for personalized advice.

Drug Interactions

It's important to be cautious when using this medication, especially regarding potential interactions with other drugs. You should avoid using it alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are taking a monoamine oxidase inhibitor (MAOI), you should not use this medication while on the MAOI or for at least two weeks after stopping it.

If you are taking the blood thinner warfarin, it's essential to consult with your doctor or pharmacist before using this medication. Also, be aware that consuming alcohol, sedatives, or tranquilizers while using this product may increase drowsiness. Always discuss your current medications and any tests with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature in a dry place. This helps maintain its effectiveness and safety. Always check the blister package before use; if it is torn, do not use the product, as this could compromise its integrity and safety. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center at 1-800-222-1222 right away. Quick medical attention is crucial for both adults and children, even if there are no immediate signs or symptoms.

FAQ

What does this drug temporarily relieve?

This drug temporarily relieves minor aches and pains, headaches, nasal congestion, sinus congestion and pressure, runny nose, and sneezing.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years of age and older should take 2 tablets every 4 hours, with a maximum of 12 tablets in 24 hours.

Can children under 12 years of age use this drug?

No, do not use this drug in children under 12 years of age, as it may lead to an overdose and potential liver damage.

What should I do if I experience a skin reaction?

If you notice symptoms like skin reddening, blisters, or rash, stop use and seek medical help immediately.

What are the liver warnings associated with this drug?

Severe liver damage may occur if you take more than 12 tablets 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 in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Is it safe to use this drug if I am pregnant or breastfeeding?

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

What precautions should I take while using this drug?

Avoid using more than directed, refrain from alcoholic drinks, and be cautious when driving or operating machinery as it may cause drowsiness.

What should I do if my symptoms worsen or new symptoms occur?

Stop taking the drug and consult your doctor if redness or swelling is present, new symptoms occur, or if pain or nasal congestion lasts more than 7 days.

Packaging Info

Below are the non-prescription pack sizes of Cold Medicine (acetaminophen chlorpheniramine maleate phenylepherine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold Medicine.
Details

Drug Information (PDF)

This file contains official product information for Cold Medicine, 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 and consists of a combination of active and inactive ingredients. The active ingredients are not specified in the provided information. Similarly, the inactive ingredients are also unspecified. The product is formulated in a dosage form that is not detailed in the text. The physical characteristics of the product, including its appearance, are not provided.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headaches. It also provides temporary relief from nasal congestion, sinus congestion and pressure, runny nose, and sneezing.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 2 tablets orally every 4 hours as needed. The maximum allowable dosage is 12 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is contraindicated, as it may result in an overdose and potentially lead to liver damage.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to acetaminophen should not use this product due to the risk of severe allergic reactions.

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes patients currently taking MAOIs or those who have discontinued MAOIs within the past two weeks, as this combination may lead to serious adverse effects.

Additionally, this product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, to avoid the risk of acetaminophen overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, as taking more than 12 tablets within a 24-hour period constitutes the maximum daily amount. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience any of the following: redness or swelling, the emergence of new symptoms, feelings of nervousness, dizziness, or sleeplessness, worsening pain or nasal congestion lasting more than seven days, or a fever that worsens or persists for more than three days. Monitoring for these symptoms is crucial to ensure patient safety and effective management of any adverse effects.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 12 tablets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three 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 stop using the product and consult a healthcare professional if they experience redness or swelling, new symptoms arise, or if they feel nervous, dizzy, or sleepless. Furthermore, if pain or nasal congestion worsens or persists for more than seven days, or if fever intensifies or lasts longer than three days, medical advice should be sought.

It is recommended that patients consult a doctor prior to use if they have a history of liver disease, heart disease, glaucoma, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis.

Patients should also seek guidance from a healthcare provider or pharmacist if they are currently taking blood-thinning medications such as warfarin or any sedatives or tranquilizers.

Drug Interactions

Concurrent use of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this product is also contraindicated in patients currently taking monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI. This interaction may lead to severe hypertensive reactions.

Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional prior to using this product. The combination may necessitate careful monitoring of coagulation parameters due to potential alterations in anticoagulant effects.

Caution is advised when using this product in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness and increase the risk of sedation-related adverse effects. Monitoring for excessive sedation is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Medicine (acetaminophen chlorpheniramine maleate phenylepherine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold Medicine.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication, as it may result in an overdose that could lead to liver damage. For adolescents and adults aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, with a maximum of 12 tablets in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children. Caution is advised when considering the use of this medication in pediatric populations.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 no specific data available regarding the excretion of this medication in 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 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.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if patients exceed the maximum daily dosage of 12 tablets within a 24-hour period. Additionally, the risk of liver damage increases if patients take other medications containing acetaminophen or consume three or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of hepatotoxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid concurrent use of other acetaminophen-containing products and excessive alcohol consumption. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Taking more than 12 tablets within a 24-hour period, which is the maximum daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should advise patients on the dangers of combining alcohol with this medication and monitor for signs of liver impairment.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function and providing supportive care are essential components of management.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and drowsiness has been noted as a potential effect. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to these effects.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important for patients to understand the potential risks and benefits associated with its use during these periods.

Providers should emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion. Patients should be informed about the importance of safeguarding medications to ensure child safety.

In the event of an overdose, healthcare providers must instruct patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. It is crucial to convey that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in blister packages. It is essential to store the product at room temperature in a dry place to maintain its integrity and effectiveness. Healthcare professionals should ensure that the blister package remains intact; the product should not be used if the blister package is torn, as this may compromise the quality and safety of the medication.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Cold Medicine, 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 Cold Medicine, 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.