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Childrens Cold Cough and Sore Throat Mixed Berry

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Active ingredients
  • Acetaminophen 325 mg/10 mL
  • Guaifenesin 200 mg/10 mL
  • Dextromethorphan Hydrobromide 10 mg/10 mL
  • Phenylephrine Hydrochloride 5 mg/10 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
February 1, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg/10 mL
  • Guaifenesin 200 mg/10 mL
  • Dextromethorphan Hydrobromide 10 mg/10 mL
  • Phenylephrine Hydrochloride 5 mg/10 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Liquid
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 2024
Label revision date
February 1, 2024
Manufacturer
AptaPharma Inc.
Registration number
M012
NDC root
76281-519
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

Maximum Strength MAX COLD & SINUS is a medication designed to temporarily relieve symptoms associated with the common cold and flu. It helps alleviate nasal congestion, a stuffy nose, minor aches and pains, sore throat, headaches, and fever. Additionally, it can relieve cough caused by minor throat and bronchial irritation and assists in loosening phlegm (mucus) to help drain bronchial tubes.

This product is suitable for children aged 6 to 12 and comes in a pleasant mixed berry flavor, making it easier for kids to take.

Uses

If you're dealing with the discomfort of a common cold or flu, this medication can help. It temporarily relieves symptoms such as nasal congestion, a stuffy nose, minor aches and pains, sore throat, headache, fever, and cough caused by minor throat and bronchial irritation.

Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, making it easier for your body to drain the bronchial tubes. This can provide you with some much-needed relief while you recover.

Dosage and Administration

Before using this medication, it's important to follow the instructions carefully to ensure your safety. Always shake the bottle well before each use. For children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours, but you should not give more than 5 doses in a 24-hour period. If symptoms persist, you can repeat the dose every 4 hours, but remember that the total use should not exceed 5 days unless your doctor advises otherwise.

For younger children under 6 years of age, this medication should not be used at all. Always use the provided dosage cup to measure the medication accurately. Be mindful not to exceed the recommended amounts, as taking more than directed can lead to serious health risks.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. There is a risk of severe liver damage if you or your child take more than five doses in 24 hours or use it alongside other medications containing acetaminophen. Additionally, be cautious of potential severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If any of these occur, stop using the medication and seek medical help immediately.

You should also consult a doctor if a sore throat is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Other signs that warrant medical attention include redness or swelling, nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than five days. If you suspect an overdose, which can also lead to liver damage, seek medical help right away, even if no symptoms are present.

Warnings and Precautions

This product contains acetaminophen, which can cause severe liver damage if your child takes more than 5 doses in 24 hours or uses it with other medications that also contain acetaminophen. Be aware that acetaminophen may lead to serious skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately. If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Before using this product, check with a doctor if your child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, breathing problems like chronic bronchitis, or a persistent cough. It's also important to avoid using this product with any other medications containing acetaminophen or if your child is taking a monoamine oxidase inhibitor (MAOI) for depression or other conditions. If your child is on the blood thinner warfarin, consult a doctor or pharmacist before use.

You should stop using this product and call your doctor if you notice redness or swelling, if your child experiences nervousness, dizziness, or sleeplessness, or if new symptoms arise. Additionally, if pain, nasal congestion, or cough worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, seek medical advice. In case of overdose, get emergency medical help or contact a Poison Control Center immediately.

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 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.

Remember, quick action can make a significant difference in ensuring safety and health. Always err on the side of caution and get help right away if you think an overdose has occurred.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus. It's essential to approach the use of this product with caution.

Additionally, you may need to adjust the dosage, so be sure to seek guidance from your healthcare provider. Keep an eye out for any adverse effects and report them to a healthcare professional promptly. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When giving this medication to children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours, but do not exceed 5 doses in a 24-hour period to avoid severe liver damage. For children under 6 years old, this medication should not be used at all. It's important to consult a doctor if your child has any existing health conditions, such as liver disease, heart disease, or breathing problems, or if they are taking the blood thinner warfarin.

If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, seek medical advice immediately. Always follow the dosing instructions carefully, and stop use if your child experiences any unusual symptoms like redness, swelling, nervousness, or if their condition worsens.

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

If your child has liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, using other medications that also contain acetaminophen can increase the risk of harm.

Before giving this product to your child, please consult with a doctor if they have liver disease. This ensures that you are making safe choices regarding their health and medication use.

Drug Interactions

It's important to be cautious when using this medication, especially if you or your child are taking other drugs. You should not use it alongside any other medication that contains acetaminophen, whether it's a prescription or over-the-counter product. Additionally, if your child is on a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain emotional conditions—you should avoid this medication while they are taking the MAOI and for at least two weeks after stopping it.

Before giving this medication to your child, it's wise to consult with a healthcare provider if they are also taking warfarin, a blood-thinning medication. Always discuss any medications or tests with your healthcare provider to ensure safety and effectiveness.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15-30°C (59-86°F). It's important not to refrigerate the product, as this can affect its effectiveness.

When using the product, a dosage cup is provided to help you measure the correct amount safely. Always handle the product with clean hands to maintain hygiene and ensure safety during use.

Additional Information

No further information is available.

FAQ

What is Maximum Strength MAX COLD & SINUS used for?

It temporarily relieves common cold and flu symptoms such as nasal congestion, stuffy nose, minor aches and pains, sore throat, headache, fever, and cough due to minor throat and bronchial irritation.

What age group is Maximum Strength MAX COLD & SINUS suitable for?

This product is intended for children aged 6 to 12 years.

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

The recommended dosage is 10 mL every 4 hours, not to exceed 5 doses in a 24-hour period.

Are there any warnings associated with Maximum Strength MAX COLD & SINUS?

Yes, severe liver damage may occur if more than 5 doses are taken in 24 hours or if used with other drugs containing acetaminophen. Additionally, consult a doctor if sore throat is severe or persists for more than 2 days.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

Is it safe to use Maximum Strength MAX COLD & SINUS during pregnancy?

The safety of this product during pregnancy has not been established, so consult a doctor before use if pregnant or planning to become pregnant.

Can nursing mothers use Maximum Strength MAX COLD & SINUS?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I do if my child experiences side effects?

Stop use and ask a doctor if redness, swelling, nervousness, dizziness, or new symptoms occur, or if pain, nasal congestion, or cough worsens or lasts more than 5 days.

How should I store Maximum Strength MAX COLD & SINUS?

Store between 15-30°C (59-86°F) and do not refrigerate.

Packaging Info

Below are the non-prescription pack sizes of Childrens Cold Cough and Sore Throat Mixed Berry (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Cold Cough and Sore Throat Mixed Berry.
Details

Drug Information (PDF)

This file contains official product information for Childrens Cold Cough and Sore Throat Mixed Berry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Maximum Strength MAX COLD & SINUS is a liquid formulation intended for pediatric use in children aged 6 to 12 years. The product is available in a 4 FL OZ (118 mL) dosage form and features a mixed berry flavor. It is designed to provide relief comparable to Mucinex® FAST-MAX™ Cold & Sinus. The National Drug Code (NDC) for this product is 76281-519-24.

The product should not be used if the printed seal under the cap is torn or missing. It is manufactured by AptaPharma Inc., located at 1533 Union Ave., Pennsauken, NJ 08110. This product is not manufactured or distributed by Reckitt Benckiser Inc., the distributor of children's Mucinex® Cold, Cough & Sore Throat liquid.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, stuffy nose, minor aches and pains, sore throat, headache, fever, and cough due to minor throat and bronchial irritation. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions to facilitate drainage from the bronchial tubes.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage to avoid the risk of overdose. Prior to administration, the product must be shaken well.

For children aged 6 to under 12 years, the recommended dosage is 10 mL every 4 hours as needed, with a maximum of 5 doses within a 24-hour period. It is important to note that this medication should not be used for more than 5 consecutive days unless directed by a physician.

For children under 6 years of age, the use of this medication is not recommended. A dosage cup should be utilized for accurate measurement of the liquid formulation.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. It is critical to adhere to the recommended dosage, as taking more than five doses within a 24-hour period, which is the maximum daily amount, or using it concurrently with other medications containing acetaminophen can significantly increase the risk of liver injury.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative 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, prompt consultation with a healthcare provider is advised.

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, it is essential to consult a healthcare professional. Additionally, this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Healthcare providers should be consulted if there is any doubt regarding the presence of an MAOI in a child's prescription.

Before administering this product, it is advisable to consult a healthcare provider if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, chronic respiratory issues such as chronic bronchitis, persistent cough associated with asthma, or cough accompanied by excessive phlegm.

Furthermore, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant warfarin.

While using this product, it is crucial to adhere strictly to the directed dosage to avoid overdose.

Discontinuation of use and consultation with a healthcare provider is warranted if any of the following occur: redness or swelling, nervousness, dizziness, sleeplessness, the emergence of new symptoms, worsening pain, nasal congestion, or cough lasting more than five days, or if fever worsens or persists beyond three days. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, these may indicate a serious condition requiring medical evaluation.

In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is essential.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who take acetaminophen concurrently with other medications containing acetaminophen. 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.

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

Additional adverse reactions warranting medical consultation include the presence of redness or swelling, nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if new symptoms arise, if pain, nasal congestion, or cough worsens or lasts longer than five days, or if fever worsens or persists beyond three days. A return of cough, particularly when accompanied by a rash or headache that lasts, may indicate a serious condition.

In cases of 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 in the absence of noticeable signs or symptoms. In such instances, contacting a Poison Control Center is advised.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, the use of this medication is contraindicated in those who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for conditions such as depression, certain psychiatric disorders, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Additionally, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to administering this medication to a child who is taking warfarin, a blood-thinning agent. Monitoring may be necessary to ensure safe and effective use in this context.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Cold Cough and Sore Throat Mixed Berry (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Cold Cough and Sore Throat Mixed Berry.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 10 mL every 4 hours. The use of this product is not recommended for children under 6 years of age.

Healthcare professionals should be aware of the potential for severe liver damage if a child exceeds 5 doses within a 24-hour period, which is the maximum daily amount. Additionally, if a pediatric patient presents with a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised.

Prior to administration, it is important to consult a doctor if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or respiratory issues such as chronic bronchitis or asthma. Caution is also warranted if the child is taking the anticoagulant warfarin; consultation with a doctor or pharmacist is recommended in such cases.

While using this product, caregivers should ensure that the dosage does not exceed the recommended amount. If any of the following occur, the product should be discontinued and a doctor consulted: redness or swelling, nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 5 days, fever worsening or lasting more than 3 days, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual.

Geriatric Use

There is no specific information 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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Use of this product should be approached with caution, and dosage adjustments may be necessary based on individual circumstances. It is important for healthcare professionals to monitor for any adverse effects in pregnant patients and to report these effects promptly.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick intervention is crucial, as the risk of liver damage can escalate rapidly, affecting both adults and children. Notably, symptoms may not be immediately apparent; therefore, it is essential to act promptly even in the absence of noticeable signs or symptoms.

Timely medical attention can significantly influence the outcome of an overdose situation, underscoring the importance of awareness and readiness to respond effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. 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 keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a dosage cup to facilitate accurate administration. It should be stored at a temperature range of 15-30°C (59-86°F). It is important to note that refrigeration is not recommended for this product. Proper storage conditions will help maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Cold Cough and Sore Throat Mixed Berry, 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 Childrens Cold Cough and Sore Throat Mixed Berry, 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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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.