Head Congestion Cold Relief

Description

The product is a combination medication designed for nighttime relief of cold symptoms, including head congestion, pain relief, and cough suppression. It contains four active ingredients: Acetaminophen for headache pain, Phenylephrine HCl for nasal congestion, Dextromethorphan HBr for coughing, and Chlorpheniramine Maleate for runny nose. The formulation is presented in the form of 12 Cool Ice® caplets. The packaging is tamper-evident, and it should not be used if the carton is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895.

Uses and Indications

This drug is indicated for the temporary relief of common cold symptoms, including minor aches and pains, headache, cough, sneezing, runny nose, nasal congestion, sinus congestion and pressure, and sore throat. Additionally, it aids in clearing nasal passages and provides cough relief to facilitate sleep.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets every 4 hours as needed. It is imperative that the caplets are swallowed whole; they should not be crushed, chewed, or dissolved. The maximum allowable dosage is 12 caplets within a 24-hour period.

For children under 12 years of age, this product is not recommended. The use of this adult formulation in children under 12 may result in exceeding the recommended dosage, which poses a risk of overdose and potential liver damage.

Healthcare professionals should advise patients to adhere strictly to these guidelines and to avoid exceeding the recommended dosage.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

• The product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Prior consultation with a healthcare professional is recommended before using this product in these circumstances.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 12 caplets within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while taking this product.

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, patients should be instructed to seek medical attention promptly. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Healthcare providers must emphasize the importance of avoiding overdose, as taking more than the recommended dose can lead to significant liver damage. In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted. It is crucial to obtain prompt medical attention for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if new symptoms arise, medical advice should be sought. A worsening fever lasting more than three days, the presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache that lasts are also indicators that warrant immediate medical evaluation, as these may signify a serious condition.

Side Effects

Patients using this product should be aware of potential adverse reactions, which may vary in seriousness and frequency.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are advised that severe liver damage may occur if they exceed 12 caplets in a 24-hour period, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

In addition to liver-related warnings, patients should be vigilant for symptoms indicating a serious condition. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are urged to consult a doctor promptly.

Patients should also discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than seven days, the emergence of new symptoms, fever worsening or lasting more than three days, presence of redness or swelling, or a cough that recurs or occurs with a rash or headache lasting. These symptoms could signify a serious underlying condition.

Before using this product, patients with certain pre-existing conditions should consult a healthcare professional. These conditions include liver disease, diabetes, heart disease, high blood pressure, glaucoma, thyroid disease, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis.

Furthermore, patients taking blood-thinning medications such as warfarin or those using sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

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

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson's disease should consult a healthcare professional before using this product. This consultation is also necessary for a period of two weeks following the discontinuation of an MAOI.

Caution is advised for individuals taking warfarin, a blood-thinning medication. It is recommended that patients seek medical advice prior to using this product in conjunction with warfarin.

The concomitant use of alcohol, sedatives, and tranquilizers may potentiate drowsiness. Monitoring for increased sedation is advised in patients who are using these substances alongside this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this adult product, as it may result in an overdose due to exceeding the recommended dosage. Such an overdose poses a risk of liver damage. Caution is advised when considering treatment options for this age group.

Geriatric Use

Elderly patients may not require specific dosage adjustments or safety considerations based on the available data. There are no distinct recommendations for geriatric use outlined in the prescribing information. Therefore, healthcare providers should assess the individual needs of elderly patients when considering treatment options, as the absence of specific guidelines does not preclude the necessity for careful monitoring and evaluation of therapy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure maternal and fetal safety.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 12 caplets within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than three alcoholic drinks per day while using this product, as alcohol consumption can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdosage, it is critical to recognize the potential for severe liver damage associated with this product, which contains acetaminophen.

Maximum Daily Dosage Healthcare professionals should advise patients that exceeding 12 caplets within a 24-hour period constitutes the maximum daily dosage. Consumption beyond this limit significantly increases the risk of hepatotoxicity.

Concurrent Use with Other Acetaminophen Products Patients must be cautioned against the concurrent use of this product with other medications containing acetaminophen. Such combinations can lead to cumulative acetaminophen intake, further elevating the risk of liver injury.

Alcohol Consumption The risk of liver damage is also heightened when this product is used in conjunction with the consumption of three or more alcoholic drinks per day. Healthcare providers should emphasize the importance of avoiding alcohol while using this medication to mitigate the risk of hepatotoxic effects.

Recommended Actions In cases of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion.

Prompt recognition and intervention are essential to prevent serious complications associated with acetaminophen overdosage.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to caution patients against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to consult a healthcare professional before using this product in such cases.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop use and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if redness or swelling is observed. Patients should also be informed to seek medical attention if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage and should avoid consuming alcoholic beverages. They should be made aware that marked drowsiness may occur, and that the use of alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should also be informed that excitability may occur, particularly in children, and they should exercise caution when driving or operating machinery.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, diabetes, heart disease, high blood pressure, glaucoma, thyroid disease, difficulty urinating due to an enlarged prostate gland, or breathing problems such as emphysema or chronic bronchitis. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled room temperature, maintaining a range of 15° to 30°C (59° to 86°F). For proper inventory management, users should refer to the end flap of the packaging for the expiration date and lot number. Special handling requirements are not specified; however, adherence to the recommended storage conditions is crucial to ensure product integrity.

Additional Clinical Information

Patients should be advised that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 12 caplets in a 24-hour period. It is important to swallow the caplets whole and not to crush, chew, or dissolve them. This product is not suitable for children under 12 years of age, as it may lead to an overdose and potential liver damage.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional before use. Additionally, it is crucial to keep the medication out of reach of children. An overdose warning is in place, as exceeding the recommended dosage may result in liver damage. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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