Head Congestion Cold Relief

Description

The product is a combination medication designed for the relief of head congestion, cold symptoms, and associated pain. It contains three active ingredients: Acetaminophen for headache pain relief, Phenylephrine HCl as a nasal decongestant for sore throat and nasal congestion, and Dextromethorphan HBr as a cough suppressant. The formulation is presented in a dosage form of 12 Cool Ice® caplets, which are non-drowsy and intended for daytime use. The packaging is tamper-evident, and the product 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, nasal congestion, cough, sore throat, and sinus congestion and pressure. Additionally, it aids in clearing nasal passages.

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 adult product is contraindicated. The use of this medication in this age group may result in exceeding the recommended dose, which poses a risk of overdose and potential liver damage.

Healthcare professionals should ensure that patients are aware of these guidelines to prevent misuse and ensure safe administration.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Exceeding the recommended dosage is also contraindicated.

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 warranted if patients are concurrently using other medications that contain acetaminophen, as this can increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product may also heighten the risk of liver damage.

In the event of a 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 consult a physician promptly.

Healthcare providers should emphasize the importance of avoiding overdose, as taking more than the recommended dose can lead to significant liver damage. In cases of suspected overdose, immediate medical assistance should be sought, and patients should be directed to contact a Poison Control Center without delay. Quick medical intervention is crucial for both adults and children, even if no symptoms are initially apparent.

Patients should be advised to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms such as pain, nasal congestion, or cough worsen or persist beyond seven days, or if new symptoms arise, medical consultation is necessary. Patients should also be cautioned to seek medical attention if fever worsens or lasts more than three days, if redness or swelling occurs, or if a cough recurs or is accompanied by a rash or headache that persists.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and specific symptoms that may indicate a need for medical consultation.

Severe liver damage may occur if patients exceed the maximum daily dosage of 12 caplets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

In addition, patients should seek medical advice 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.

Patients are advised to discontinue use and consult a doctor 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 that worsens or lasts more than three days, redness or swelling, or a cough that recurs or is associated with a rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition.

Before using this product, patients should consult a healthcare professional if they have a history of diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), heart disease, liver disease, or a cough that produces excessive phlegm.

Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

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

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to mitigate the risk of altered anticoagulant effects.

Packaging & NDC

Below are the non-prescription pack sizes of Head Congestion Cold Relief (acetaminophen, 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 that exceeds the recommended dosage. Such an overdose poses a risk of liver damage. Caution is advised when considering the use of this product in younger populations.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 mitigate risks associated with acetaminophen use.

Overdosage

Severe liver damage may occur with an overdose of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical points regarding overdosage.

Maximum Daily Amount The maximum recommended dosage is 12 caplets within a 24-hour period. Exceeding this limit significantly increases the risk of liver injury.

Concurrent Use with Other Acetaminophen-Containing Products Patients should be cautioned against the simultaneous use of this product with other medications that also contain acetaminophen. This practice can lead to unintentional overdosing and subsequent liver damage.

Alcohol Consumption The risk of liver damage is further heightened in individuals who consume three or more alcoholic drinks daily while using this product. Healthcare providers should advise patients to limit alcohol intake to mitigate this risk.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor for symptoms of liver damage and initiate appropriate management procedures as necessary.

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 specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients not to exceed the recommended dosage of the medication, as taking more than the prescribed amount may lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be encouraged to consult with their healthcare provider prior to using this medication if they have any of the following conditions: diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, heart disease, liver disease, or a cough that produces excessive phlegm (mucus).

Additionally, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist before using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature ranging from 15° to 30°C (59° to 86°F) to maintain its efficacy.

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number, ensuring proper tracking and compliance with storage requirements. Special handling needs are not specified; however, adherence to the recommended temperature range is essential for optimal product integrity.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 caplets every 4 hours, not to exceed 12 caplets within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.

View product document (PDF)