Childrens Cold, Cough and Sore Throat

Description

NDC 68016-224-00. Premier Value® Children's Cold, Cough, and Sore Throat is a liquid formulation designed for pediatric use in children aged 6 to 12 years. The active ingredients include Acetaminophen (100 mg), Guaifenesin (100 mg), Dextromethorphan HBr (5 mg), and Phenylephrine HCl (2.5 mg). This product serves multiple therapeutic purposes: it acts as a pain reliever and fever reducer, expectorant, cough suppressant, and nasal decongestant. The formulation is presented in a mixed berry flavor and is contained in a 4 FL OZ (118 mL) bottle. It is important to note that the product should not be used if the printed seal under the cap is torn or missing. This product is independently tested for satisfaction and is not manufactured or distributed by Reckitt Benckiser Inc., the distributor of Children’s Mucinex® Cold, Cough, and Sore Throat Liquid.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, minor aches and pains, headache, stuffy nose, sore throat, fever, and cough due to minor throat and bronchial irritation. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions to facilitate drainage of 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 and administration guidelines. The medication must be shaken well before each use.

For children aged 6 to under 12 years, the recommended dose is 2 teaspoonfuls. It is important to note that this medication should not be administered more than 5 times within a 24-hour period. If symptoms persist, doses may be repeated every 4 hours as needed, but the total duration of use should not exceed 5 days unless directed by a physician.

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

Healthcare professionals should also remind patients of the importance of not exceeding the directed dosage to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drugs containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In pediatric patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a child's prescription, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period, the maximum daily amount, or if it is used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to monitor the total daily intake of acetaminophen from all sources to prevent potential hepatotoxicity.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

General precautions must be observed when administering this product. It should not be used in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, healthcare providers should be consulted for clarification. 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. It is essential to verify with a healthcare professional if there is any doubt regarding the presence of an MAOI in the child’s medication regimen.

Caregivers should be instructed to discontinue use and seek medical advice if any of the following occur: redness or swelling at the site of administration, nervousness, dizziness, or sleeplessness, the emergence of new symptoms, worsening pain, nasal congestion, or cough lasting more than five days, fever that worsens or persists beyond three days, or a cough that recurs or is accompanied by a rash or headache. These symptoms may indicate a serious condition requiring further investigation.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control center is advised. Prompt action is critical to mitigate potential adverse effects associated with acetaminophen overdose.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and severe throat conditions.

Severe liver damage may occur if the maximum daily dosage of acetaminophen is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. In cases of overdose, which may also lead to liver damage, it is crucial to seek medical assistance immediately or contact a Poison Control Center, even if no symptoms are initially apparent.

Patients should discontinue use and consult a healthcare professional if they experience redness or swelling, nervousness, dizziness, sleeplessness, or if new symptoms arise. Additionally, worsening pain, nasal congestion, or cough lasting more than five days, as well as fever persisting beyond three days, warrant medical evaluation. A cough that recurs or is accompanied by a rash or headache that lasts should also be assessed, as these may indicate a serious underlying condition.

Before using this product, it is advisable for patients to consult a healthcare provider if they have a history of liver disease, high blood pressure, diabetes, heart disease, thyroid disease, or respiratory issues such as chronic bronchitis. Those with persistent or chronic coughs, particularly those associated with asthma or excessive mucus, should also seek medical advice prior to use. Furthermore, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

In summary, while this product can be effective, careful consideration of these warnings and potential adverse reactions is essential for patient safety.

Drug Interactions

Co-administration of this medication with other drugs 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 have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and 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 on 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 (acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 2 teaspoonfuls. The use of this medication 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.

This medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. Prior to administration, it is important to consult a doctor if the child has liver disease, high blood pressure, diabetes, heart disease, thyroid disease, or respiratory issues such as chronic bronchitis or asthma.

Furthermore, healthcare providers should inquire about the use of blood-thinning medications, such as warfarin, before prescribing this treatment. Parents and caregivers should be instructed to discontinue use and seek medical advice if the child experiences redness or swelling, nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 5 days, or if fever worsens or lasts more than 3 days. Cough that recurs or occurs with a rash or headache that persists should also prompt medical consultation.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in this population, which may necessitate dosage adjustments or increased monitoring.

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; however, specific studies or data regarding these risks are not provided in the prescribing information.

No specific dosage modifications for pregnant individuals are mentioned; therefore, it is essential for healthcare providers to offer personalized advice based on the individual patient's circumstances. This product should only be used if clearly needed and after thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available regarding excretion in breast milk or effects on nursing infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Exceeding this limit, particularly in patients with compromised liver function, may significantly increase the risk of hepatotoxicity. Additionally, caution should be exercised if the patient is concurrently using other medications that contain acetaminophen, as this may further elevate the risk of liver injury. Regular assessment of liver function is recommended to ensure patient safety and to mitigate potential adverse effects associated with acetaminophen use in this population.

Overdosage

Taking this product in excess of the recommended dosage may lead to serious health consequences, including potential liver damage. It is imperative that healthcare professionals advise patients to adhere strictly to the dosing instructions provided.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers should instruct patients or caregivers to contact a Poison Control Center without delay. Prompt medical intervention is crucial, even if the individual does not exhibit any immediate signs or symptoms of overdose. Early recognition and management of an overdose can significantly mitigate the risk of severe complications.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should seek medical help or contact a Poison Control center immediately.

Patients should be informed not to use this medication in conjunction with any other drugs containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult a doctor or pharmacist.

It is crucial to inform patients that this medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. Patients should be advised to check with a healthcare professional if they are unsure whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience redness or swelling, nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if new symptoms arise, or if pain, nasal congestion, or cough worsens or persists for more than five days. If fever increases or lasts longer than three days, or if a cough recurs or is accompanied by a rash or headache that lasts, patients should also contact a healthcare provider, as these may indicate a serious condition.

Before using this medication, patients should be encouraged to consult a doctor if their child has any of the following conditions: liver disease, high blood pressure, diabetes, heart disease, thyroid disease, or any breathing problems such as chronic bronchitis. Furthermore, patients should seek medical advice if their child has a persistent or chronic cough, particularly one associated with asthma, or if the cough is accompanied by excessive phlegm. Lastly, patients should consult a doctor or pharmacist if their child is taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that includes a dosing cup. It is essential to store the product at a temperature range of 15-30 °C (59-86 °F). Refrigeration is not recommended, as the product should not be exposed to temperatures outside this specified range. Proper handling and storage conditions are crucial to 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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