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Baczol Cold Medicine

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Active ingredients
  • Chlorpheniramine Maleate 4 mg/5 mL
  • Acetaminophen 250 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
  • Phenylephrine Hydrochloride 10 mg/5 mL
Other brand names
Drug classes
Histamine-1 Receptor Antagonist, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 27, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Chlorpheniramine Maleate 4 mg/5 mL
  • Acetaminophen 250 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
  • Phenylephrine Hydrochloride 10 mg/5 mL
Other brand names
Drug classes
Histamine-1 Receptor Antagonist, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Syrup
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 2020
Label revision date
December 27, 2024
Manufacturer
Procaps S. A. de C. V.
Registration number
M012
NDC root
76864-208
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

Baczol® is a cold medicine designed to help relieve various symptoms associated with colds and allergies. It contains several active ingredients: acetaminophen, which helps reduce pain and fever; dextromethorphan HBr, a cough suppressant that calms the cough control center; chlorpheniramine maleate, an antihistamine that alleviates sneezing and itchy eyes; and phenylephrine HCl, a nasal decongestant that helps clear nasal congestion.

You can use Baczol® to temporarily relieve symptoms such as a runny nose, sneezing, itchy throat, and nasal congestion due to the common cold or hay fever. It also helps with minor aches and pains and can reduce fever. This product is sugar-free and alcohol-free, making it a suitable option for many individuals looking for relief from cold symptoms.

Uses

If you're dealing with symptoms from hay fever, this medication can help. It temporarily relieves a runny nose, sneezing, and itching in your nose or throat, as well as itchy, watery eyes. If you have a common cold, it can also ease nasal congestion and calm your cough. Additionally, it alleviates minor aches and pains that often accompany a cold and can temporarily reduce fever.

This medication is designed to provide you with relief from these uncomfortable symptoms, helping you feel better while you recover.

Dosage and Administration

When taking this medication, adults and children aged 12 years and older should take 1 teaspoon (5 mL) every 4 hours. If your child is between 6 and under 12 years old, the recommended dose is 1/2 teaspoon (2.5 mL) every 4 hours. For children under 6 years of age, it’s important to consult a doctor before giving them this medication.

Make sure not to exceed 6 doses in a 24-hour period for both children and adults. This helps ensure safety and effectiveness while using the medication. Always follow these guidelines to get the best results.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson's disease, or for two weeks after stopping an MAOI. Additionally, do not use it with any other medication that contains acetaminophen, and avoid it if you are allergic to acetaminophen or any of its inactive ingredients. This product is not suitable for treating persistent or chronic coughs related to smoking, asthma, or emphysema, especially if accompanied by excessive mucus, unless directed by a doctor. If you are taking sedatives or tranquilizers, consult your doctor before use.

While using this product, it’s important not to exceed the recommended dosage. You should also avoid consuming alcoholic beverages and refrain from driving or operating machinery if you experience drowsiness.

Side Effects

Using this product may lead to some serious side effects, particularly related to liver health. It's important to be aware that taking more than 6 doses in 24 hours can cause severe liver damage, especially if you consume alcohol regularly or are using other medications that contain acetaminophen. If you or a child accidentally take more than the recommended dose, seek medical help immediately, even if no symptoms are present.

Additionally, if you are taking the blood thinner warfarin, consult with your doctor or pharmacist before using this product. Be cautious as it contains FD&C Yellow #5 (Tartrazine), which is a color additive that some individuals may be sensitive to. Always follow dosing guidelines and consult a healthcare professional if you have any concerns.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if not used carefully. You should not take more than 6 doses in 24 hours, and this limit applies to both adults and children. Be cautious if you consume 3 or more alcoholic drinks daily while using this product, as this increases the risk of liver damage. Additionally, do not give this medication to children under 3 years old or use it for more than 10 days unless your doctor advises otherwise.

While using this product, always follow the recommended dosage. If you experience nervousness, dizziness, or sleeplessness, stop using it and consult your doctor. Be aware that this medication may cause drowsiness, which can be worsened by alcohol or other sedatives, so avoid drinking alcohol and use caution when driving or operating machinery. If you are taking the blood-thinning medication warfarin, check with your doctor or pharmacist before using this product.

Overdose

Taking more than the recommended dose of this medication can lead to serious liver damage. If you suspect an overdose, it’s important to act quickly. Contact your physician or the Poison Control Center immediately, even if you don’t see any signs or symptoms.

Prompt medical attention is crucial for both adults and children in these situations. Remember, it’s always better to be safe and seek help if you think an overdose may have occurred.

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

It's important to be cautious when giving this medication to children. You should not give it to children under 3 years of age or use it for more than 10 days unless a doctor has specifically instructed you to do so. For children aged 6 to under 12 years, the recommended dosage is 1/2 teaspoon (2.5 mL) every 4 hours, but make sure not to exceed 6 doses in a 24-hour period. If your child is under 6 years old, it's best to consult a doctor before administering the medication. Always prioritize your child's safety and follow these guidelines closely.

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 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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

It's important to be cautious if you have liver problems, especially when using products that contain acetaminophen. This medication can cause severe liver damage if you take more than 6 doses in a 24-hour period, which is the maximum recommended amount for adults and children. Additionally, combining it with other medications that also contain acetaminophen can increase the risk of liver damage. If you consume 3 or more alcoholic drinks daily, you should avoid using this product, as it can further strain your liver.

For children, do not give this medication to those under 3 years of age, and avoid using it for more than 10 days unless a doctor advises otherwise. Always consult with your healthcare provider if you have any concerns about using acetaminophen, especially if you have existing liver conditions.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are taking certain other drugs. For instance, if you are on the blood thinner warfarin, you should consult your doctor or pharmacist first. Additionally, you should not use this medication if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or other mental health conditions, or if you have stopped taking one in the last two weeks.

Be cautious about using this medication alongside any other products that contain acetaminophen, as combining them can be harmful. If you are taking sedatives or tranquilizers, it's also wise to check with your doctor before starting this medication. Always ensure you discuss all your medications and health conditions with your healthcare provider to avoid any potential interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 15º-30ºC (59º-86ºF). This temperature range helps maintain the product's integrity. Always check for any signs of tampering before use; if you notice anything unusual, do not use the product.

Handling the product with care is essential. Make sure to keep it in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Baczol®?

Baczol® is a cold medicine that temporarily relieves symptoms such as runny nose, sneezing, and cough.

What are the key ingredients in Baczol®?

Baczol® contains acetaminophen (an analgesic and antipyretic), dextromethorphan HBr (a cough suppressant), chlorpheniramine maleate (an antihistamine), and phenylephrine HCl (a nasal decongestant).

What symptoms does Baczol® relieve?

It relieves runny nose, sneezing, nasal congestion, cough, minor aches and pains, and temporarily reduces fever.

What is the dosage for adults and children over 12?

Adults and children 12 years and older should take 1 teaspoon (5 mL) every 4 hours.

What is the dosage for children aged 6 to under 12?

Children aged 6 to under 12 should take 1/2 teaspoon (2.5 mL) every 4 hours.

What should I do if I have a child under 6?

For children under 6 years of age, you should ask a doctor for the appropriate dosage.

What is the maximum dosage for Baczol®?

Do not exceed more than 6 doses in a 24-hour period for both children and adults.

Are there any warnings associated with Baczol®?

Yes, it contains acetaminophen, which can cause severe liver damage if taken in excess or with alcohol. Avoid using it with other acetaminophen-containing products.

Can I use Baczol® if I am pregnant or breastfeeding?

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

What should I avoid while taking Baczol®?

Avoid alcoholic beverages and operating machinery if drowsiness occurs while taking this product.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Baczol Cold Medicine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Baczol® is a cold medicine formulated for the relief of symptoms associated with colds and allergies. The product contains the following active ingredients: Acetaminophen, an analgesic and antipyretic; Dextromethorphan HBr, a cough suppressant; Chlorpheniramine Maleate, an antihistamine; and Phenylephrine HCl, a nasal decongestant.

This formulation is sugar-free and alcohol-free, presented in a liquid dosage form with a volume of 4 fl. oz. (120 mL). The product features a fruit flavor and is intended for sale in the United States only. It is manufactured for Laboratorios López, S.A. de C.V., located in Soyapango, San Salvador, El Salvador, C.A. Baczol® is a registered trademark of Laboratorios López, S.A. de C.V. Users are advised to shake well before use. The National Drug Code (NDC) for this product is 76864-208-01.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hay fever, including runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes. It also provides relief from nasal congestion due to the common cold and calms the cough control center to alleviate coughing. Additionally, this drug alleviates minor aches and pains associated with the common cold and temporarily reduces fever.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 1 teaspoon (5 mL) administered every 4 hours. For children aged 6 to under 12 years, the dosage is 1/2 teaspoon (2.5 mL) every 4 hours. For children under 6 years of age, it is advised to consult a physician for appropriate dosing.

It is important to note that the maximum dosage should not exceed 6 doses within a 24-hour period for both children and adults. Healthcare professionals should ensure that patients adhere to these guidelines to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have discontinued MAOI therapy within the past two weeks, due to the risk of serious interactions. Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated to prevent potential overdose.

Individuals with a known allergy to acetaminophen or any inactive ingredients in the formulation should not use this product. It is contraindicated for the treatment of persistent or chronic cough associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm, unless directed by a healthcare professional. Additionally, the use of this product is contraindicated in patients taking sedatives or tranquilizers without prior consultation with a physician.

Patients should not exceed the recommended dosage while using this product. Alcoholic beverages should be avoided during treatment, and caution is advised regarding driving or operating machinery if drowsiness occurs.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of liver damage. Severe liver injury may occur under the following circumstances: if an adult exceeds 6 doses within a 24-hour period, which is the maximum daily limit; if a child takes more than 6 doses in 24 hours; if this product is used concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic beverages daily while using this product. It is imperative that this product not be administered to children under 3 years of age or used for more than 10 days unless specifically directed by a physician.

When utilizing this product, healthcare professionals should advise patients to adhere strictly to the recommended dosage. The occurrence of nervousness, dizziness, or sleeplessness warrants immediate discontinuation of the product and consultation with a healthcare provider. Additionally, this product may induce excitability, particularly in children, and can cause drowsiness. The sedative effects may be amplified when combined with alcohol, sedatives, or tranquilizers. Therefore, patients should be cautioned against the consumption of alcoholic beverages while taking this product. Caution is also advised when driving or operating machinery due to the potential for drowsiness.

Healthcare professionals should inquire about the use of blood-thinning medications, such as warfarin, prior to recommending this product, as interactions may necessitate further monitoring or adjustment of therapy.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen under certain conditions. Specifically, adults should not exceed 6 doses in a 24-hour period, which is the maximum daily amount. Children are also advised against taking more than 6 doses in the same timeframe. The risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product. It is contraindicated for children under 3 years of age and should not be used for more than 10 days unless directed by a physician.

In the event of an overdose, which may result from taking more than the recommended dose, patients are at risk for liver damage. Immediate medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent. In cases of accidental overdose, it is imperative to contact a physician or Poison Control Center without delay.

Additionally, this product contains FD&C Yellow #5 (Tartrazine) as a color additive, which may require consultation with a healthcare provider. Patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

Patients should exercise caution regarding potential drug interactions when using this medication.

Anticoagulants Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional prior to use. Monitoring of coagulation parameters may be necessary to ensure safe use.

Monoamine Oxidase Inhibitors (MAOIs) The use of this medication is contraindicated in patients currently taking a prescription MAOI or within two weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson's disease, and concurrent use may lead to serious adverse effects.

Acetaminophen-containing Products This medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the contents of their medications are advised to consult a healthcare professional for clarification.

Sedatives and Tranquilizers Patients who are currently taking sedatives or tranquilizers should seek medical advice before using this medication. Monitoring for enhanced sedative effects may be warranted in these cases.

Packaging & NDC

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

Packaging configurations for Baczol Cold Medicine.
Details

Pediatric Use

Pediatric patients under 3 years of age should not be administered this medication, and use beyond 10 days is not recommended unless directed by a physician. For children aged 6 to under 12 years, the recommended dosage is 1/2 teaspoon (2.5 mL) every 4 hours. For children under 6 years of age, consultation with a doctor is advised prior to use. It is important to note that the total number of doses for pediatric patients should not exceed 6 doses within a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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. Severe liver damage may occur if the maximum daily dosage is exceeded. Specifically, adults should not take more than 6 doses in a 24-hour period, and the same restriction applies to children. Additionally, patients should be cautioned against the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage.

For adults who consume 3 or more alcoholic drinks daily, the use of this product is not recommended due to the heightened risk of severe liver damage. Furthermore, this product should not be administered to children under 3 years of age, and its use should not extend beyond 10 days unless directed by a physician. Regular assessment of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. In the event of an accidental overdose, it is imperative to contact a physician or the Poison Control Center immediately.

Recommended Actions

Prompt medical attention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent. Healthcare professionals should be vigilant in assessing the situation, as early intervention can significantly impact outcomes.

Potential Symptoms

While specific symptoms of overdose may not be immediately evident, the risk of liver damage underscores the importance of seeking medical advice without delay.

Management Procedures

Upon contacting medical professionals, they may initiate appropriate management protocols based on the severity of the overdose and the patient's clinical presentation. Continuous monitoring and supportive care may be necessary to mitigate potential complications associated with liver damage.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis, and liver damage, particularly associated with excessive use of acetaminophen. Dizziness and drowsiness have been reported, especially when the product is used in conjunction with alcohol or sedatives. Additionally, excitability has been observed in children.

Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported. There have been instances of gastrointestinal bleeding linked to the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in combination with this product. Furthermore, cases of respiratory depression have been noted, particularly in patients with pre-existing respiratory conditions.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for two weeks after stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult their doctor or pharmacist.

Patients should also be cautioned against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is any doubt regarding the presence of acetaminophen in other medications, patients should seek guidance from a healthcare professional. Additionally, patients with known allergies to acetaminophen or any inactive ingredients in the product should refrain from use.

It is important to inform patients that this product is not intended for the treatment of persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, especially if accompanied by excessive phlegm, unless directed by a doctor. Patients taking sedatives or tranquilizers should consult their doctor before using this product.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and advise patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Patients should be made aware that the product may cause excitability, particularly in children, and may induce drowsiness. They should be advised to avoid alcoholic beverages while taking this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Finally, patients should be cautioned to use caution when driving or operating machinery while using this product. It is also advisable for patients to consult their doctor or pharmacist before use if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 15º-30ºC (59º-86ºF). Healthcare professionals should ensure that the product is not used if there is any evidence of tampering, as this may compromise safety and efficacy. Proper handling and storage conditions are crucial to maintaining the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Baczol 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 Baczol 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.

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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.