Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Acetaminophen/Guaifenesin/Dextromethorphan hydrobromide/Phenylephrine hydroch...

Last content change checked dailysee data sync status

Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
May 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
May 17, 2024
Manufacturer
OPMX LLC
Registration number
M012
NDC root
69729-782
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

COLDTAC is a medication designed to temporarily relieve symptoms associated with the common cold and flu. It works by alleviating nasal and sinus congestion, reducing pressure, and easing coughs caused by minor throat and bronchial irritation. Additionally, COLDTAC helps to relieve minor aches and pains, headaches, fever, and sore throats.

This medication also promotes nasal and sinus drainage, reduces swelling in the nasal passages, and helps loosen phlegm (mucus) to make coughs more productive. By restoring freer breathing through the nose, COLDTAC aims to provide you with comfort during cold and flu season.

Uses

You can use this medication to temporarily relieve symptoms associated with the common cold and flu. It helps with nasal and sinus congestion, making it easier for you to breathe through your nose. If you're experiencing a cough due to minor throat or bronchial irritation, this medication can also provide relief.

In addition to easing congestion, it can help reduce minor aches and pains, headaches, fever, and sore throat. It promotes drainage in your nasal and sinus passages and helps loosen phlegm (mucus), making coughs more productive by clearing out bothersome mucus from your bronchial passageways.

Dosage and Administration

It's important to take this medication exactly as directed to avoid any potential overdose. For adults and children aged 12 years and older, you should take 2 softgels with a full glass of water every 4 hours. However, make sure not to exceed 4 doses within a 24-hour period.

If you have children aged 4 to under 12 years, it's best to consult a doctor before giving them this medication. Additionally, if you are using other nighttime or daytime products, be sure to read each label carefully to ensure you are dosing correctly and not exceeding the recommended amounts.

What to Avoid

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

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It contains acetaminophen, which can lead to severe liver damage if you exceed 4 doses in 24 hours, especially if you also take other medications with acetaminophen or consume 3 or more alcoholic drinks daily. Additionally, acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

It's also important to consult your doctor if you have a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. You should stop using the product and contact a healthcare professional if you experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 7 days, or if you notice any new symptoms. These could indicate a more serious condition.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4 doses in 24 hours, especially if you also consume 3 or more alcoholic drinks daily. Be aware that acetaminophen may cause serious skin reactions, such as redness, blisters, or rash. If you notice any skin issues, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, do not take it with any other medications containing acetaminophen, and avoid it if you are currently on a prescription monoamine oxidase inhibitor (MAOI) or have certain health conditions like liver disease, high blood pressure, or diabetes. Always ask your doctor or pharmacist if you are unsure about any medications you are taking, especially if you are on blood thinners like warfarin. Use this product only as directed, and if you experience nervousness, dizziness, or if your symptoms worsen or new symptoms appear, stop taking it and contact your doctor.

Overdose

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

Signs of an overdose can vary, but it’s essential to be vigilant. If you notice anything unusual or if you’re unsure, don’t hesitate to get help. Remember, prompt medical attention can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When it comes to using this medication for children, it's important to follow specific guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours. However, if your child is between 4 and under 12 years old, you should consult a doctor before giving them this medication. This ensures that you receive the best advice tailored to your child's needs. Always prioritize safety and seek professional guidance when it comes to medications for younger children.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 be cautious when using products that contain acetaminophen. Taking more than 4 doses in a 24-hour period can lead to severe liver damage, especially if you also consume three or more alcoholic drinks daily. This is the maximum daily amount for this product, so please adhere to it strictly.

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

Drug Interactions

It's important to be cautious when taking this medication, especially regarding potential interactions with other drugs. You should avoid using it alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are currently taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain emotional conditions—or if you have stopped taking one in the last two weeks, you should not use this medication.

Before starting this medication, it's a good idea to consult with your doctor or pharmacist if you are taking warfarin, a blood-thinning medication. Discussing all your current medications and any health conditions with your healthcare provider can help ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20-25°C (68-77ºF). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality and effectiveness.

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

Additional Information

No further information is available.

FAQ

What is COLDTAC used for?

COLDTAC is used to temporarily relieve common cold and flu symptoms, including nasal congestion, sinus pressure, cough, minor aches, headache, fever, and sore throat.

How does COLDTAC work?

COLDTAC relieves nasal and sinus congestion, promotes drainage, and helps loosen phlegm (mucus) to make coughs more productive.

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

Adults and children 12 years and over should take 2 softgels with water every 4 hours, not exceeding 4 doses in 24 hours.

What should I do if I experience a severe skin reaction?

If you experience symptoms like skin reddening, blisters, or rash, stop using COLDTAC and seek medical help immediately.

Are there any warnings associated with COLDTAC?

Yes, COLDTAC contains acetaminophen, which can cause severe liver damage if more than 4 doses are taken in 24 hours. Consult a doctor if you have liver disease or are taking blood thinners.

Can I use COLDTAC if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using COLDTAC.

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

Stop using COLDTAC and consult a doctor if your pain, nasal congestion, or cough worsens or lasts more than 7 days, or if you develop new symptoms.

How should COLDTAC be stored?

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

Packaging Info

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

Packaging configurations for Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

COLDTAC is a pharmaceutical formulation designed for therapeutic use. The specific chemical composition and structural details are proprietary. The product is available in a dosage form suitable for administration as indicated in the prescribing information. COLDTAC exhibits a defined molecular weight, contributing to its pharmacokinetic properties. The formulation includes a selection of inactive ingredients that facilitate its stability and efficacy. The appearance of COLDTAC is consistent with standard pharmaceutical practices, ensuring quality and reliability in its application.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, and sore throat.

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps to loosen phlegm (mucus) and thin bronchial secretions. This action aids in clearing the bronchial passageways of bothersome mucus, thereby making coughs more productive.

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

Dosage and Administration

Patients should take the medication only as directed, adhering to the overdose warning provided. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is two softgels taken with water every four hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing guidance.

When using other nighttime or daytime products, it is essential to carefully read each label to ensure correct dosing and avoid potential overdose.

Contraindications

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if more than 4 doses are taken within a 24-hour period. This limit applies to the maximum daily amount of acetaminophen from all sources, including other medications. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may increase the risk of liver damage.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be directed to consult a doctor or pharmacist. Furthermore, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients should be encouraged to verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

Before using this product, patients should be advised to consult a healthcare professional if they have any of the following conditions: liver disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist prior to use.

Patients must adhere strictly to the recommended dosage and should not exceed the directed amount.

Immediate medical attention should be sought if a skin reaction occurs.

Patients should discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or lasts more than 3 days; presence of redness or swelling; occurrence of new symptoms; or if a cough recurs or is accompanied by a rash or headache that persists.

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 4 doses in 24 hours, which is the maximum daily amount for this product when taken with other drugs containing acetaminophen, or if they consume 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a doctor promptly.

Other adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include the onset of nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or lasts more than 3 days; presence of redness or swelling; occurrence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting for an extended period. These symptoms could indicate a serious condition requiring medical evaluation.

Drug Interactions

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

Pharmacodynamic interactions are significant with monoamine oxidase inhibitors (MAOIs). This medication should not be administered to patients currently taking a prescription MAOI or within 2 weeks of discontinuing such treatment. The combination may lead to severe hypertensive reactions or other adverse effects.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to use to assess the need for dosage adjustments or increased monitoring of coagulation parameters.

Packaging & NDC

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

Packaging configurations for Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl.
Details

Pediatric Use

Pediatric patients aged 12 years and older are recommended to take 2 softgels with water every 4 hours as needed. For children aged 4 to under 12 years, it is advised to consult a doctor before administration.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed 4 doses within a 24-hour period, as this is the maximum daily amount for this product. Additionally, consumption of 3 or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

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

Healthcare professionals are advised to ensure that patients and caregivers are aware of the importance of adhering to the recommended dosage instructions. In cases of suspected overdose, the potential for serious health consequences necessitates swift action to mitigate risks and provide appropriate care.

Nonclinical Toxicology

No teratogenic effects have been observed in nonclinical studies. Additionally, there are no reported non-teratogenic effects. The available data does not provide any specific details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

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

Patient Counseling

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ideally between 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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.