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 flu, including minor aches and pains, nasal congestion, headache, fever, sore throat, sinus congestion and pressure, and cough due to minor throat and bronchial irritation. It is also indicated for nighttime relief of cough, runny nose, and sneezing.

Additionally, this drug reduces swelling of the nasal passages and temporarily restores freer breathing through the nose. It promotes nasal and/or sinus drainage and helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus and making coughs more productive during the daytime.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the specified limits. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours as needed. It is important to note that no more than 8 caplets of the Daytime and Nighttime products should be consumed within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician before administration.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated; if there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is any doubt about the presence of an MAOI in a current prescription, a healthcare professional should be consulted.

Lastly, patients should not take DAYTIME and NIGHTTIME products simultaneously.

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 they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate an allergic reaction. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

Healthcare professionals should exercise caution and recommend that patients consult a doctor before using this product if they have any of the following conditions: liver disease, diabetes, high blood pressure, glaucoma (for nighttime use), thyroid disease, heart disease, cough associated with excessive phlegm, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema for daytime use), difficulty urinating due to prostate enlargement, or chronic cough and breathing problems (for nighttime use).

Additionally, patients should be advised to consult a doctor or pharmacist prior to use if they are taking blood thinners such as warfarin or sedatives and tranquilizers (for nighttime use).

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to seek emergency medical help or contact a Poison Control Center without delay, 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 seven days; 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.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance immediately.

Patients should be vigilant for symptoms that warrant discontinuation of the product and consultation with a healthcare provider. These symptoms include nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache, as these may indicate a serious condition.

During the use of this product, it is crucial for patients to adhere to the recommended dosage to avoid adverse effects. Notably, excitability and marked drowsiness may occur, particularly in children when used at nighttime. Patients are also cautioned against the consumption of alcoholic beverages, as well as the use of sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving or operating machinery due to the potential for increased drowsiness.

Patients with certain pre-existing conditions should consult a healthcare provider prior to use. These conditions include liver disease, diabetes, high blood pressure, glaucoma (for nighttime use), thyroid disease, heart disease, and chronic respiratory issues such as persistent cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing difficulty in urination due to prostate enlargement should seek medical advice. It is also recommended that patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers (for nighttime use) consult a healthcare professional before using this product.

Drug Interactions

There are currently no documented drug interactions associated with 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 Cold and Flu (acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For patients aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours.

Caution is advised as excitability may occur, particularly in children, when used at nighttime. Additionally, marked drowsiness may also be experienced during nighttime use.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, high blood pressure, glaucoma (specifically for nighttime use), thyroid disease, heart disease, difficulty in urination due to prostate gland enlargement, or any breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema (also for nighttime use).

Additionally, elderly patients should be aware that this product may impair their ability to drive a motor vehicle or operate machinery, especially when used at night. The concomitant use of alcohol, sedatives, and tranquilizers may further enhance drowsiness, necessitating careful consideration and monitoring of these factors in geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 prescribing information 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage. Patients are advised to avoid exceeding a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic beverages daily while using this product may further increase the risk of liver damage. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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: nervousness, dizziness, or sleeplessness; worsening or persistent pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or lasts more than 3 days; presence of redness or swelling; emergence of new symptoms; or if a cough recurs or occurs alongside a rash or headache that persists. 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 in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to take DAYTIME and NIGHTTIME products concurrently, as this could lead to adverse effects. It is important to communicate the necessity of adhering to the recommended dosage and to avoid exceeding it.

For those using the NIGHTTIME product, healthcare providers should inform patients that excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect, and patients should be cautioned against consuming alcoholic beverages, as this may exacerbate drowsiness.

Patients should also be made aware of the risks associated with driving or operating machinery while using the NIGHTTIME product, as drowsiness can impair their ability to perform these tasks safely. Furthermore, the use of alcohol, sedatives, and tranquilizers in conjunction with the NIGHTTIME product may increase drowsiness, and patients should be advised to exercise caution in these situations.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). For proper identification, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum limit of 8 caplets from both Daytime and Nighttime products within a 24-hour period.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, resources regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

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