Up and up Nighttime Severe Cold and Flu

Description

This formulation is designed for the relief of nighttime severe cold and flu symptoms. It is presented in a liquid dosage form with a honey flavor and has a total volume of 12 fluid ounces (355 mL). The active ingredients include acetaminophen, which serves as a pain reliever and fever reducer; phenylephrine hydrochloride, a nasal decongestant; dextromethorphan hydrobromide, a cough suppressant; and doxylamine succinate, an antihistamine. This combination addresses symptoms such as headache, fever, sore throat, minor aches and pains, sneezing, runny nose, nasal and sinus congestion, sinus pressure, and cough. The product is marketed under the Up & up™ brand.

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, cough to facilitate sleep, minor aches and pains, headache, sore throat, fever, runny nose, and sneezing. Additionally, this drug 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 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 before administration. The medication is contraindicated for 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 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.

• Use in children for the purpose of inducing sleep, as this is not an approved indication and may pose safety risks.

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 three or more alcoholic drinks 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 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 instructed to seek medical advice if they have any of the following conditions: liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, a cough that produces excessive phlegm, difficulty urinating due to an enlarged prostate gland, or any breathing problems such as emphysema or chronic bronchitis. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also consult a healthcare provider.

Patients should also be advised to consult a doctor or pharmacist before using this product if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

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 or seek emergency medical help right away, regardless of whether signs or symptoms are present.

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 lasts, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with the use of this product include the potential for severe liver damage, particularly if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, a child takes more than five doses in 24 hours, or if the product is used concurrently with other medications containing acetaminophen. Additionally, the risk of liver damage increases for adults who consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the possibility 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.

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

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are cautioned to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Care should be taken when driving or operating machinery.

Patients are advised to stop use and consult 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 is accompanied by a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients should seek medical advice if they have a history of liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, a cough associated with excessive phlegm, difficulty urinating due to an enlarged prostate, or any breathing problems such as emphysema or chronic bronchitis. Additionally, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a healthcare professional prior to use.

Drug Interactions

The concomitant use of this product with warfarin, a blood-thinning agent, may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Co-administration with alcohol, sedatives, or tranquilizers may enhance drowsiness. Patients should be cautioned regarding the potential for increased sedation and advised to avoid activities requiring full alertness until they are aware of how the combination affects them.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, to prevent the risk of acetaminophen overdose.

Additionally, the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. Monitoring for adverse effects is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Up and up Nighttime Severe Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 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 that excitability may occur, particularly in pediatric patients. If pain, nasal congestion, or cough worsens or persists beyond 5 days in children, or 7 days in adults, further evaluation is necessary. Additionally, if fever worsens or lasts more than 3 days, medical attention should be sought.

In the event of an overdose, immediate medical assistance is crucial. Parents and caregivers should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is essential for both children and adults.

Geriatric Use

There is no specific information available 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 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 no specific data available regarding the excretion of this medication in 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

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 based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications arising from the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. Additionally, excitability has been observed, particularly in pediatric populations.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

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 temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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