Daytime Severe

Description

H•E•B® Daytime SEVERE is a cold and flu relief formulation designed for daytime use. It contains acetaminophen as a pain reliever and fever reducer, guaifenesin as an expectorant, phenylephrine HCl as a nasal decongestant, and dextromethorphan HBr as a cough suppressant. The product is presented in a honey flavor and is formulated to be non-drowsy. Each bottle contains 12 FL OZ (355 mL) of the solution, which is comparable to Vicks® DayQuil® Severe Honey Flavor in its active ingredients.

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: nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, and sore throat.

Additionally, this drug reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps loosen phlegm (mucus) and thin bronchial secretions. This action aids in clearing the bronchial passageways of bothersome mucus, thereby making coughs more productive.

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

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.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, not to exceed 4 doses within a 24-hour period. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours, also limited to a maximum of 4 doses in a 24-hour timeframe.

For children aged 4 to under 6 years, it is advised to consult a healthcare professional 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:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, 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.

• In individuals with a known history of allergic reactions to this product or any of its components, to prevent potential severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in 24 hours. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to 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 severe sore throat that persists for more than two days, or if it is accompanied or followed 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, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough that produces excessive phlegm. Additionally, individuals with a persistent or chronic cough, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare provider before use. It is also recommended that patients taking the anticoagulant warfarin consult with a doctor or pharmacist prior to using this product.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no signs or symptoms are apparent.

Patients should discontinue use and contact a healthcare provider if they experience any of the following: increased nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or lasts more than 3 days; presence of redness or swelling; occurrence of new symptoms; or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. 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 product is used concurrently with other medications 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, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should consult a healthcare provider if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

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 develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected, as these may indicate a serious condition.

Before using this product, patients with liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland should consult a healthcare provider. Additionally, those with a cough that produces excessive phlegm or a persistent or chronic cough, such as that 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. Prompt 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 necessitate careful monitoring due to potential interactions that could affect anticoagulation levels.

Additionally, the use of 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. Patients uncertain about whether their prescription includes an MAOI should seek guidance from a healthcare provider before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Severe (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 receive a dosage of 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before administration. The use of this medication is not recommended for children under 4 years of age.

Healthcare professionals should be aware of the critical nature of overdose situations in pediatric patients. Quick medical attention is essential for children, even if no signs or symptoms of overdose are immediately apparent.

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 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 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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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, as exceeding this limit may lead to significant hepatic injury.

Additionally, patients who consume three or more alcoholic drinks daily are at an increased risk of severe liver damage when using this product. Therefore, it is advised that patients with compromised liver function consult a healthcare professional prior to use.

Monitoring of liver function may be warranted in patients with existing liver disease, and any signs of hepatic distress should prompt immediate medical evaluation.

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 initiate appropriate treatment protocols based on the specific circumstances of the overdose.

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 that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, it is recommended to stop use and consult a healthcare professional if any of the following occur: worsening or persistent pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or lasts more than 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting longer than expected. These symptoms may indicate a serious underlying 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 for clarification.

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. Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Patients should also be instructed to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults. Additionally, they should be informed to contact a doctor if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Patients should be particularly vigilant and 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 to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not recommended for this product. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 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, it is recommended to consult a doctor, and the product should not be used in children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is essential to keep the medication 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 Daytime Severe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)