Equate Daytime Cold and Flu

Description

equate™ is a maximum strength formulation designed for daytime relief from severe cold and flu symptoms. This non-drowsy liquid contains a combination of active ingredients including acetaminophen, which serves as a pain reliever and fever reducer for headaches, sore throats, and minor aches and pains; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant for chest congestion; and phenylephrine HCl, which acts as a nasal decongestant to alleviate nasal and sinus congestion as well as sinus pressure. The product is alcohol-free and is packaged in a 12 FL OZ (355 mL) bottle.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: sinus congestion and pressure, nasal congestion, minor aches and pains, headache, sore throat, fever, and cough due to minor throat and bronchial irritation.

Additionally, this drug reduces swelling of the nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways and making coughs more productive.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent the risk of overdose.

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 advice from a healthcare professional.

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period; if a child takes more than 5 doses in 24 hours; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough that produces excessive phlegm, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before use.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than five doses in the same timeframe, or if the medication is taken concurrently with other products containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat warning is also in place; 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 healthcare provider promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness, if pain, nasal congestion, or cough worsens or lasts longer than five days in children or seven days in adults, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing a cough with excessive phlegm or trouble urinating due to an enlarged prostate gland should consult a healthcare provider. Additionally, individuals with a persistent or chronic cough, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using acetaminophen.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are currently taking warfarin, a blood-thinning medication. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters and potential dosage adjustments of warfarin.

Additionally, this product is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. The concurrent use of this product with MAOIs may lead to serious adverse effects. Patients should verify with their healthcare provider or pharmacist if they are uncertain whether their prescription includes an MAOI.

Packaging & NDC

Below are the non-prescription pack sizes of Equate Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the critical need for quick medical attention in the event of an overdose in pediatric patients, even if no signs or symptoms are immediately apparent. Additionally, if pain, nasal congestion, or cough worsens or persists for more than 5 days in children, further evaluation is warranted.

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

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 safe use during pregnancy and lactation.

Lactation

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

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 consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure the patient's safety while on this medication.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers remain vigilant and prepared to assess the patient's condition thoroughly, as timely treatment can significantly influence outcomes.

In cases of suspected overdose, the following steps should be taken:

1. Assessment of Symptoms: Monitor the patient for any signs of overdose, which may include but are not limited to altered mental status, respiratory distress, or cardiovascular instability.

2. Supportive Care: Initiate supportive care measures as necessary, including airway management, oxygen supplementation, and intravenous fluids, depending on the clinical presentation.

3. Decontamination: If appropriate and within the timeframe, consider gastrointestinal decontamination methods, such as activated charcoal, while adhering to established protocols.

4. Continuous Monitoring: Maintain continuous monitoring of vital signs and clinical status to detect any deterioration promptly.

5. Consultation: Engage with a medical toxicologist or poison control specialist for guidance on specific antidotes or advanced treatment options, if indicated.

Healthcare professionals are encouraged to familiarize themselves with the specific management protocols for the substance involved in the overdose to ensure optimal patient care.

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 question.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reports indicate that symptoms 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.

Additionally, users are instructed to stop use and consult a healthcare professional if they experience redness or swelling, the emergence of new symptoms, or if a cough recurs or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Patients should be made aware that they should stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists beyond 5 days for children or 7 days for adults. They should also be informed to consult a doctor if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Furthermore, patients should be advised to seek medical attention if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a cough associated with excessive phlegm, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to take 30 mL every 4 hours, while those between 6 to under 12 years should take 15 mL every 4 hours. For children aged 4 to under 6 years, consultation with a healthcare provider is recommended, and the product should not be used in children under 4 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)