Onessip Adult Daytime Severe Cold and Flu

Description

No description information is available for the specified drug.

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 to 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 take the medication only as directed and must not exceed a total of 4 doses (4 sachets) within a 24-hour period. It is essential to follow the instructions provided on the carton for proper use.

For adults and children aged 12 years and older, the recommended dosage is 15 mL (1 sachet) every 4 hours as needed. For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for use in children under 4 years of age.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI before using this product.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if an adult exceeds 4 doses (30 mL each) within a 24-hour period, or if a child exceeds 4 doses (15 mL each) in the same timeframe. Additionally, the risk of liver damage increases if the product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

In the event of an overdose, it is imperative to seek emergency medical help or contact a Poison Control Center without delay. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to stop taking the product and consult a healthcare professional if they experience any of the following: 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 persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache that lasts.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product, specifically if an adult takes more than 4 doses (30 mL each) within a 24-hour period, or if a child takes more than 4 doses (15 mL each) in the same timeframe. The risk of liver damage is further increased when this product is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

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 also be advised to consult a healthcare provider 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.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare professional include nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, patients should seek medical advice. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than expected also necessitate medical consultation.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare provider prior to use. Furthermore, individuals with a cough that produces excessive phlegm or those suffering from persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product.

It is advisable for patients taking the blood-thinning medication warfarin to consult a doctor or pharmacist before using this product to avoid potential interactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Onessip Adult Daytime Severe Cold and Flu (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should receive dosing instructions from a healthcare professional. For children under 4 years of age, the use of this medication is not recommended. The maximum daily dosage for pediatric patients is limited to 4 doses of 15 mL each within a 24-hour period.

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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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 specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met:

• Adults should not exceed 4 doses (30 mL each) in a 24-hour period, which is the maximum daily amount for this product.

• Children should not exceed 4 doses (15 mL each) in a 24-hour period, which is also the maximum daily amount for this product.

• Caution is advised if this product is taken concurrently with other medications containing acetaminophen, as this may increase the risk of liver damage.

• Adults who consume 3 or more alcoholic drinks daily while using this product are at an elevated risk for severe liver damage.

Due to these risks, it is recommended that patients with compromised liver function consult a healthcare professional for appropriate dosage adjustments and monitoring.

Overdosage

Severe liver damage is a potential consequence of overdosage with this product. For adults, the risk increases significantly if more than 4 doses (30 mL each) are taken within a 24-hour period, exceeding the maximum recommended daily amount. Similarly, for children, taking more than 4 doses (15 mL each) in the same timeframe poses a serious risk of severe liver damage.

In the event of an overdose, it is crucial to stop use and seek medical help immediately if any skin reactions occur. Such reactions may indicate an overdose or a severe adverse reaction, necessitating prompt medical evaluation and intervention.

Healthcare professionals should monitor patients for symptoms of liver damage and provide appropriate management based on clinical presentation and laboratory findings.

Nonclinical Toxicology

No teratogenic effects have been identified in the available nonclinical studies. Additionally, there is no information regarding non-teratogenic effects. The data does not provide insights into animal pharmacology and toxicology. Furthermore, there are no findings related to carcinogenesis or mutagenesis. Overall, the nonclinical toxicology data remains limited and does not indicate any significant adverse effects in the evaluated studies.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing surveillance. Symptoms of these reactions 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.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must 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 apparent.

Patients should be informed not to use this medication in conjunction with any other drug 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 essential to caution patients against using this medication 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 ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days for children or 7 days for adults. If fever worsens or lasts more than 3 days, or if redness or swelling occurs, patients should also stop use and contact a healthcare professional. New symptoms or a cough that returns or occurs with a rash or persistent headache should prompt immediate medical consultation, as these may indicate a serious condition.

While using this product, patients must adhere strictly to the recommended dosage and not exceed the directed amount. It is advisable for patients to consult a doctor before using this medication if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also seek medical advice if they have a cough accompanied by excessive phlegm or a persistent cough associated with smoking, asthma, chronic bronchitis, or emphysema. Those on a sodium-restricted diet or taking the blood-thinning medication warfarin should also consult a healthcare provider or pharmacist before use.

Storage and Handling

The product is supplied in packaging that includes NDC numbers relevant to its configuration. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Healthcare professionals are advised to inspect the carton and sachet prior to use; the product should not be utilized if either is found to be torn, broken, or punctured. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)