Cold Relief

Description

EQUALINE® is a multi-symptom cold relief medication available in the form of 24 caplets. Each caplet contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. This formulation is free from pseudoephedrine. The product is distributed by UNFI, located in Providence, RI 02908, USA, and can be contacted at 855-423-2630. The packaging is tamper evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, nasal congestion, headache, cough, sinus congestion and pressure, and sore throat. It aids in clearing nasal passages and promotes nasal and sinus drainage. Additionally, this drug temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets every 4 hours as needed. The caplets should be swallowed whole; they must not be crushed, chewed, or dissolved. It is imperative that no more than 10 caplets are taken within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic beverages daily while taking this product.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include blisters, rash, and skin reddening. Should any of these reactions occur, patients must 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, patients should be instructed to consult a physician without delay.

General precautions should be taken when considering this product for patients with specific health conditions. Healthcare providers should recommend that patients consult a doctor prior to use if they have diabetes, a cough associated with excessive phlegm, difficulty urinating due to prostate enlargement, liver disease, heart disease, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), thyroid disease, or high blood pressure. Additionally, patients taking the anticoagulant warfarin should seek advice from a healthcare professional or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if new symptoms arise, medical consultation is warranted. Patients should also seek medical advice 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 lasting beyond a reasonable duration, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver damage and allergic reactions.

Severe liver damage may occur if patients exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for symptoms indicating a need for medical consultation. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Furthermore, patients are advised to stop use and seek medical advice if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if new symptoms arise; if fever worsens or persists for more than three days; if redness or swelling is observed; or if a cough recurs or occurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

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 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe use and to mitigate the risk of increased bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of 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 consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. Caution is advised when administering to younger children, and healthcare providers should be consulted to ensure appropriate use and dosing.

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 adverse effects or changes in therapeutic response, 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, including blisters, rash, and skin reddening. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage of the medication. Patients must be informed that exceeding the recommended dosage can lead to serious health risks.

In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly mitigate potential health complications associated with overdose situations.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed 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 10 caplets in a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Additionally, parents are encouraged to educate themselves about the potential for medicine abuse among teenagers by visiting www.StopMedicineAbuse.org.

Drug Information (PDF)

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

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