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Complete Cold Relief

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Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
  • Phenylephrine Hydrochloride 10 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
December 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
  • Phenylephrine Hydrochloride 10 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
December 12, 2025
Manufacturer
Belmora LLC
Registration number
M012
NDC root
27854-299
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

Buckleys is a medication designed to provide complete relief from cold symptoms. It contains several key ingredients: acetaminophen, which helps reduce pain and fever; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant that helps loosen mucus; and phenylephrine HCl, a nasal decongestant. Together, these components work to temporarily relieve common cold and flu symptoms such as minor aches and pains, sinus congestion, stuffy nose, sore throat, cough, and headache.

In addition to alleviating these symptoms, Buckleys promotes nasal and sinus drainage, reduces fever, and helps make coughs more productive by thinning bronchial secretions. This makes it easier for you to clear mucus from your airways, providing a more comfortable experience when you're feeling under the weather.

Uses

This medication is designed to help you feel better when you're dealing with common cold and flu symptoms. It can temporarily relieve minor aches and pains, sinus congestion and pressure, a stuffy or runny nose, a sore throat, cough, and headaches. If you're feeling under the weather, this product can also promote nasal and sinus drainage, reduce fever, and help loosen phlegm (mucus) in your airways, making it easier to cough up bothersome mucus.

By addressing these symptoms, the medication aims to make you more comfortable while your body fights off the illness.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should not take more than the directed amount, and make sure not to exceed 6 doses within a 24-hour period. Always use the dose cup that comes with the medication for accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 20 mL every 4 hours. However, if you are caring for children under 12 years old, this medication is not suitable for them, so please do not use it. Always consult with your doctor if you have any questions or concerns about the dosage.

What to Avoid

You should avoid using this product if you are currently taking any other medication that contains acetaminophen, whether it's a prescription or over-the-counter drug. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, or for two weeks after stopping an MAOI. If you have a history of allergic reactions to this product or any of its ingredients, you should also refrain from using it.

While using this product, it's crucial that you do not exceed the recommended dosage. Misusing or abusing this medication can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as blisters, rash, or skin reddening. If you experience any of these symptoms, stop using the product and seek medical help immediately.

You should consult a doctor if your pain, nasal congestion, or cough worsens or lasts more than seven days, if you develop new symptoms, or if you experience nervousness, dizziness, or sleeplessness. Additionally, if you have a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it's important to seek medical advice. Always talk to your doctor before using this product if you have certain health conditions, such as liver disease, heart disease, or diabetes, or if you are taking blood thinners like warfarin.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as blisters or rashes. 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 two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, it's important to talk to your doctor if you have any of the following conditions: liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, diabetes, or a chronic cough. If you are taking the blood thinner warfarin, check with your doctor or pharmacist before use. If you experience an overdose, seek emergency medical help or contact a Poison Control Center right away, even if you don't notice any symptoms.

You should stop using this product and call your doctor if your pain, nasal congestion, or cough worsens or lasts more than seven days, if new symptoms develop, or if you experience nervousness, dizziness, sleeplessness, or a fever that lasts more than three days. Additionally, if your cough returns with a rash or headache that persists, or if you notice redness or swelling, these could be signs of a serious condition that requires medical attention.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Remember, acting quickly can make a significant difference, so don’t hesitate to get help.

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 medication for children. If your child is under 12 years old, you should not use this medication. For those aged 12 and older, the recommended dose is 20 mL taken every 4 hours using the dosing cup provided.

In the event of an overdose, it’s crucial to seek medical help immediately, regardless of whether your child shows any signs or symptoms. Always prioritize safety and consult with a healthcare professional if you have any questions or concerns about medication use in children.

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 considering this medication, it’s important to consult with a healthcare provider. 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 consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Additionally, if you have liver disease, you should also seek medical advice before starting this treatment. Your healthcare provider can help determine the best approach for your specific situation and ensure your safety while using the medication.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period, using it alongside other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage.

Before using this product, you should consult your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are paramount, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) for short periods. Always check the expiration date on the package and use the product before this date to guarantee its effectiveness.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Proper storage and careful handling are essential for your safety and the product's performance.

Additional Information

If you are considering using this medication, it is important to know how to take it properly. For adults and children aged 12 years and older, the recommended dose is 20 mL taken every 4 hours using the dosing cup provided. However, this medication should not be used by children under 12 years of age.

If you are pregnant or breastfeeding, make sure to consult a healthcare professional before using this medication. Additionally, be aware of the potential for medicine abuse, especially among teens. You can find more information on this topic at www.StopMedicineAbuse.org.

FAQ

What is Buckleys used for?

Buckleys is used for complete cold relief, temporarily relieving symptoms such as minor aches, sinus congestion, stuffy nose, sore throat, cough, and headache.

What are the key ingredients in Buckleys?

The key ingredients in Buckleys include acetaminophen (pain reliever/fever reducer), dextromethorphan HBr (cough suppressant), guaifenesin (expectorant), and phenylephrine HCl (nasal decongestant).

Who can use Buckleys?

Buckleys is indicated for adults and children aged 12 years and over. It should not be used by children under 12 years.

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

The recommended dosage for adults and children 12 years and over is 20 mL every 4 hours, using the dosing cup provided.

Are there any warnings associated with Buckleys?

Yes, you should not exceed 6 doses in 24 hours, and it contains acetaminophen, which can cause severe liver damage if taken in excess or with other acetaminophen-containing drugs.

What should I do if I experience severe skin reactions?

If you experience severe skin reactions such as blisters or rash, stop using Buckleys and seek medical help immediately.

Can I use Buckleys if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical.

Where is Buckleys manufactured?

Buckleys is manufactured by Belmora LLC, located at 3033 Wilson Blvd. Suite 700, Arlington, VA 22201.

What flavor does Buckleys come in?

Buckleys is available in a mixed berry flavor.

Packaging Info

Below are the non-prescription pack sizes of Complete Cold Relief (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Complete Cold Relief.
Details

Drug Information (PDF)

This file contains official product information for Complete Cold Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, sinus congestion and pressure, stuffy nose, nasal congestion, sore throat, cough, and headache. Additionally, it promotes nasal and/or sinus drainage, reduces fever, and helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum allowable dosage is 6 doses within a 24-hour period. It is imperative that only the dose cup provided with the medication is utilized for accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. For children under 12 years of age, the use of this medication is not recommended.

Healthcare professionals should ensure that patients understand the importance of not exceeding the directed dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

  • Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

  • In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek guidance from a healthcare professional.

  • In individuals with a known allergy to this product or any of its ingredients, as this may result in severe allergic reactions.

Additionally, it is important to adhere to the recommended dosage to avoid potential adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as blisters, rash, or skin reddening. 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 if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: cough with excessive phlegm (mucus), liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, diabetes, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before use.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare provider if any of the following occur: worsening pain, nasal congestion, or cough lasting more than seven days; the emergence of new symptoms; feelings of nervousness, dizziness, or sleeplessness; fever worsening or lasting more than three days; recurrence of cough accompanied by rash or headache; or the presence of redness or swelling, as these may indicate a serious condition.

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 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Additionally, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are also advised to stop use and contact a doctor if pain, nasal congestion, or cough worsens or lasts longer than seven days, if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness. Furthermore, if fever worsens or lasts more than three days, or if a cough recurs with a rash or headache that persists, these may indicate a serious condition requiring medical evaluation. Redness or swelling should also prompt consultation with a healthcare provider.

Before using this product, patients should seek medical advice if they have a cough associated with excessive phlegm, liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, diabetes, or a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Complete Cold Relief (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Complete Cold Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 20 mL administered in the dosing cup provided every 4 hours.

In the event of an overdose, it is essential to seek prompt medical attention for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before initiating treatment, as liver function may influence renal clearance and overall drug metabolism. Monitoring and appropriate dosing adjustments may be necessary for patients with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

Prior to using this product, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of treatment and to discuss any necessary monitoring or dosage adjustments. Regular 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 medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. It is important for healthcare providers to encourage patients to consult with a doctor prior to use if they have any of the following conditions: a cough that produces excessive phlegm (mucus), liver disease, thyroid disease, heart disease, difficulty urinating due to an enlarged prostate gland, high blood pressure, diabetes, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Additionally, patients should be advised to consult with a doctor or pharmacist before using this medication if they are currently taking the blood-thinning medication warfarin. This precaution is essential to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted within the range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

Additionally, information regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org. No further details are available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Complete Cold Relief, 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 Complete Cold Relief, 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.