Onessip Adult Nighttime 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 alleviates nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, headache, fever, sore throat, runny nose, and sneezing. Additionally, it reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

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 4 doses (4 sachets) within a 24-hour period. It is essential to follow the instructions provided on the carton for ease of 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, is prohibited 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.

• The product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if an adult exceeds 4 doses (15 mL each) within a 24-hour period, which is the maximum daily dosage for this product. Additionally, caution is warranted if the product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Patients should be instructed to discontinue use immediately and seek medical assistance if any skin reactions occur.

In cases of severe sore throat, particularly if it persists for more than two days or is 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. Quick medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

Patients should be instructed to stop taking the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts should also prompt a consultation, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the recommended dosage of more than 4 doses (15 mL each) within a 24-hour period, take other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the risk of severe skin reactions, 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.

Additionally, patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include symptoms such as nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts beyond 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 with a rash or headache that persists.

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

It is advisable for patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers 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 the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For dosing, adults and children aged 12 years and older are recommended to take 15 mL (1 Sachet) every 4 hours. It is important to note that excitability may occur, particularly in children.

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 potential adverse effects or changes in efficacy, 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 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if the maximum daily dosage of 4 doses (15 mL each) is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen.

Patients with compromised liver function who consume 3 or more alcoholic drinks daily while using this product are at an elevated risk for severe liver damage. It is recommended that healthcare providers closely monitor liver function in these patients and consider alternative pain management strategies if necessary.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdose.

Healthcare providers should monitor patients closely for any signs or symptoms that may arise from an overdose of the medication. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, it is recommended that healthcare professionals initiate supportive care immediately. This may involve maintaining the patient's airway, breathing, and circulation, as well as providing symptomatic treatment as necessary.

Additionally, contacting a poison control center or a medical toxicologist for guidance on specific management strategies is advisable. It is crucial to gather as much information as possible regarding the substance involved, the amount taken, and the time of ingestion to facilitate appropriate treatment.

Documentation of the incident and ongoing monitoring of the patient’s condition are also critical components of effective management in cases of overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. 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 product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

It is essential to caution patients against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last 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 in children or 7 days in 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 patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must adhere strictly to the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients are advised to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution should be exercised when driving or operating machinery.

Patients should be encouraged to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or difficulty urinating due to an enlarged prostate gland. They should also seek medical advice if they have a cough accompanied by excessive phlegm or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients on a sodium-restricted diet or those taking the blood-thinning medication warfarin should consult their healthcare provider or pharmacist before use.

Storage and Handling

The product is supplied in packaging that includes cartons and sachets. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Healthcare professionals should ensure that the carton or sachet is not torn, broken, or punctured prior to use, as such conditions may compromise the product's quality and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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