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Cold Medicine

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Active ingredients
  • Chlorpheniramine Maleate 4 mg
  • Acetaminophen 325 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 2017
Label revision date
October 24, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Chlorpheniramine Maleate 4 mg
  • Acetaminophen 325 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 2017
Label revision date
October 24, 2024
Manufacturer
Selder, S. A. de C. V.
Registration number
M012
NDC root
63654-601
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

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 addresses nasal issues. You can count on it to temporarily relieve nasal congestion, sinus congestion and pressure, a runny nose, and sneezing. This makes it a handy option when you're experiencing cold or allergy symptoms.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as needed. However, it's important not to exceed 6 tablets in a 24-hour period to avoid taking too much medication. For children under 12 years of age, this product is not suitable, as it contains a dosage that is too high for younger children.

To take the medication, simply swallow 1 tablet with water. Remember to space out your doses by at least 4 hours, and keep track of how many tablets you have taken to ensure you stay within the recommended limit.

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 alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter.

It's important to follow the dosing instructions carefully. Do not exceed the recommended amount, and avoid using it for more than 10 days unless your doctor advises otherwise. If you are treating a fever, limit use to no more than 3 days without consulting your doctor. Lastly, please refrain from consuming alcoholic drinks while using this medication.

Side Effects

Taking this medication can lead to some serious side effects, particularly concerning your liver. You should avoid taking more than 6 tablets in a 24-hour period, using it alongside other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product, as these actions can increase the risk of severe liver damage.

Additionally, be aware that acetaminophen may cause severe skin reactions, which can include symptoms like skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the medication and seek medical help immediately. It's also important to consult a doctor if you experience redness or swelling, new symptoms, increased nervousness, dizziness, sleeplessness, worsening pain or nasal congestion lasting more than 7 days, or a fever that lasts more than 3 days. If you have certain health conditions, such as liver disease, heart disease, or diabetes, or if you are taking specific medications like warfarin, please talk to your doctor before using this product.

Warnings and Precautions

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 skin reactions, stop using the product immediately and seek medical help.

It's important to get emergency medical assistance right away if you suspect an overdose, even if you don't see any symptoms. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Also, stop taking the medication and call your doctor if you notice redness or swelling, develop new symptoms, feel nervous, dizzy, or have trouble sleeping, or if pain or nasal congestion worsens or lasts longer than 7 days. If your fever gets worse or lasts more than 3 days, reach out to your doctor as well.

Overdose

Taking more than 6 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 3 or more alcoholic drinks daily while using this product can also result in serious liver issues.

If you suspect an overdose, look for signs such as unusual tiredness, nausea, vomiting, or 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 and any medications you may consider.

Pediatric Use

If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age. The dosage in this product is too high for younger children, which could lead to serious side effects. For those aged 12 and older, the recommended dosage is one tablet every four hours, but be sure not to exceed six tablets in a 24-hour period.

Additionally, be aware that some children may experience excitability (increased energy or restlessness) as a side effect. Always consult with a healthcare professional if you have any concerns about using this medication for your child.

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 before starting the medication. 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 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 be cautious when using products that contain acetaminophen. Taking more than 6 tablets in a 24-hour period can lead to severe liver damage. This is the maximum daily amount, and you should also avoid using other medications that contain acetaminophen at the same time. Additionally, consuming 3 or more alcoholic drinks each day while using this product can further increase the risk of liver damage.

Always consult with your healthcare provider before using acetaminophen if you have liver issues, as they may recommend specific guidelines or adjustments to ensure your safety.

Drug Interactions

It's important to be cautious when taking this medication. You should not use it alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are currently taking a monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks, you should avoid this medication.

Before using this medication, consult with your doctor or pharmacist if you are taking blood thinners like warfarin, or if you are using sedatives or tranquilizers, as these can increase drowsiness when combined. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 59-86°F (15-30°C). It's important to check the packaging before use; if the package is torn or damaged, do not use the product, as this could compromise its effectiveness and safety.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure a safe experience.

Additional Information

You should take this medication orally. For adults and children aged 12 and older, the recommended dose is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. However, this product is not suitable for children under 12 years old due to the high medication content.

If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Be aware that taking more than the recommended dose can lead to liver damage. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are present.

FAQ

What symptoms 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 1 tablet every 4 hours, with a maximum of 6 tablets in 24 hours.

Can children under 12 years of age use this product?

No, children under 12 years of age should not use this product as it contains too much medication for them.

What should I do if I experience a skin reaction?

If you experience 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 6 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) right away, as quick medical attention is critical.

Are there any contraindications for using this drug?

Yes, do not use this drug if you are allergic to acetaminophen, taking a monoamine oxidase inhibitor (MAOI), or using any other drug containing acetaminophen.

What precautions should I take if I have certain health conditions?

Ask a doctor before use if you have liver disease, heart disease, glaucoma, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

Is it safe to use this drug while pregnant or breastfeeding?

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

What should I avoid while taking this medication?

Avoid using more than directed, consuming alcoholic drinks, and operating machinery if you experience drowsiness.

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 drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XL" on one side and "3" on the other side, containing 3 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and an Opadry white coating, which consists of hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80.

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 1 tablet orally every 4 hours as needed. It is imperative that no more than 6 tablets are consumed within a 24-hour period to avoid potential overdose.

This product is not recommended for use in children under 12 years of age, as it contains a dosage that may be excessive for this population.

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 concurrent use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated, as it may lead to significant drug interactions. This includes the use of MAOIs for depression, psychiatric, or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI.

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 6 tablets in a 24-hour period constitutes the maximum daily amount. Additionally, patients should be cautioned against using this product in conjunction with other medications that contain acetaminophen, as this increases the risk of liver injury. Consumption of 3 or more alcoholic drinks daily while using this product may also heighten the risk of severe liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must be instructed to 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 crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be advised to stop taking the product and consult 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 7 days, or a fever that worsens or persists for more than 3 days. Monitoring for these symptoms is essential to ensure patient safety and effective management of any adverse effects.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 6 tablets within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised to stop use and consult a healthcare professional if they experience redness or swelling, new symptoms arise, or if they feel nervous, dizzy, or sleepless. Additionally, if pain or nasal congestion worsens or persists for more than 7 days, or if fever intensifies or lasts longer than 3 days, medical advice should be sought.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, glaucoma, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland should consult a healthcare provider. Furthermore, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should also seek guidance from a doctor or pharmacist prior to use.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is not recommended in patients currently taking monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing an MAOI. This combination may lead to serious adverse effects.

Patients taking anticoagulants such as warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Caution is advised for individuals using sedatives or tranquilizers alongside this medication. The combination may enhance the sedative effects, leading to increased drowsiness. Monitoring for excessive sedation is recommended in these 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 product due to the excessive medication content for this age group. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 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 product 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 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 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 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 should be aware of the potential risks associated with the use of this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period. This limit applies not only to the product itself but also to the total intake of acetaminophen from all sources, including other medications that may contain acetaminophen.

Additionally, patients with compromised liver function should exercise caution if they consume 3 or more alcoholic drinks daily while using this product, as this may further increase the risk of liver damage. Monitoring of liver function is recommended for patients with hepatic impairment who are prescribed this product, and they should be advised to adhere strictly to the recommended dosage guidelines to minimize the risk of adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Severe Liver Damage Taking more than 6 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 Considerations 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 alcohol consumption in conjunction with this medication and monitor for signs of liver impairment.

In the event of suspected overdosage, immediate medical evaluation is recommended to assess liver function and initiate appropriate management strategies.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Severe skin reactions have been reported in association with acetaminophen use, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance. Additionally, side effects can be reported to the designated contact number, 1-855-259-1590, available Monday through Friday from 9 AM to 5 PM EST.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important to emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion.

Providers should also inform patients about the risks associated with overdose. Patients must be made aware that taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick 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 packaging that must be inspected prior to use. It should not be utilized if the package is torn or damaged.

For optimal storage conditions, the product should be maintained at room temperature, specifically within the range of 59-86°F (15-30°C). Proper handling and storage are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 1 tablet every 4 hours, not exceeding 6 tablets within a 24-hour period. The product is not recommended for children under 12 years of age due to the potential for excessive medication.

Clinicians should counsel patients regarding the use of the product during pregnancy or breastfeeding, advising them to consult a health professional prior to use. An overdose warning is also critical; exceeding the recommended dosage may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

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.