Cold and Flu

Description

NDC 11822-5034-8 is a combination medication indicated for the relief of symptoms associated with cold and flu. The formulation includes active ingredients comparable to those found in Tylenol® COLD + FLU SEVERE Day and Night products.

The daytime formulation contains acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl, serving as a pain reliever and fever reducer, cough suppressant, expectorant, and nasal decongestant. It is indicated for the relief of fever, headache, sore throat, nasal congestion, cough, mucus, and chest congestion.

The nighttime formulation includes acetaminophen, chlorpheniramine maleate, dextromethorphan HBr, and phenylephrine HCl, functioning as a pain reliever and fever reducer, antihistamine, cough suppressant, and nasal decongestant. It is indicated for the relief of fever, headache, sore throat, runny nose, cough, and nasal congestion.

This product is formulated without pseudoephedrine and is available in a package containing 16 daytime caplets and 8 nighttime caplets. The packaging is tamper-evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is not manufactured or distributed by Johnson & Johnson Corporation, the owner of the registered trademarks Tylenol® COLD + FLU SEVERE Day and Tylenol® COLD + FLU SEVERE Night.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough, headache, sore throat, nasal congestion, minor aches and pains, sinus congestion and pressure, sneezing, and runny nose (for nighttime use only). It assists in loosening phlegm (mucus) and thinning bronchial secretions to enhance cough productivity (for daytime use only) and aids in clearing nasal passages. Additionally, it provides relief from cough to facilitate sleep and temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets orally every 4 hours as needed. It is essential that the caplets are swallowed whole; they should not be crushed, chewed, or dissolved. The maximum allowable dosage is 10 caplets within a 24-hour period. For children under 12 years of age, it is advised to consult a physician before administration.

Contraindications

The concurrent use of DAYTIME and NIGHTTIME products is contraindicated. Additionally, this product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription; if there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Use is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to use.

Lastly, this product is contraindicated in individuals with a history of allergic reactions to it or any of its ingredients.

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.

Patients should be alerted to the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must 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 instructed to consult a physician promptly.

General precautions should be taken when considering the use of this product. Patients should be advised to consult a healthcare provider prior to use if they have any of the following conditions: high blood pressure, liver disease, diabetes, thyroid disease, heart disease, glaucoma (specifically for nighttime use), a cough that produces excessive phlegm, difficulty urinating due to prostate enlargement, or persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with breathing problems such as emphysema or chronic bronchitis should use caution, particularly at night.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to seek emergency medical help or contact a Poison Control Center without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 new symptoms arise; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 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. If any of these symptoms occur, patients are advised 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 consult a healthcare professional promptly.

Patients should also stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if new symptoms arise; if fever worsens or lasts more than three days; if redness or swelling is present; or if cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Additional adverse reactions noted include excitability, particularly in children, and marked drowsiness, which may occur during nighttime use. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery during nighttime use due to the potential for increased drowsiness.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for patients who are using sedatives or tranquilizers, particularly at nighttime, as these substances may enhance drowsiness when taken in conjunction with this medication. Monitoring for increased sedation is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, 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. In children, particularly during nighttime administration, excitability may occur, and marked drowsiness is also a potential side effect.

For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. Caution is advised when administering this medication to pediatric patients due to the potential for adverse effects.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns based on the available information. However, it is advisable for geriatric patients to consult a healthcare provider prior to use, particularly if they have pre-existing conditions such as high blood pressure, liver disease, diabetes, thyroid disease, heart disease, or glaucoma, especially when using the medication at nighttime.

Caution is recommended for elderly patients when engaging in activities that require alertness, such as driving a motor vehicle or operating machinery, particularly during nighttime use. Additionally, the concurrent use of alcohol, sedatives, or tranquilizers may enhance drowsiness, which is a consideration that should be taken into account for this population. Regular monitoring and assessment of the patient's response to treatment are advisable to ensure safety and 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

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. Caution is advised when driving a motor vehicle or operating machinery, especially in individuals with reduced kidney function.

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 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients who consume three or more alcoholic drinks daily should refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

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 comprehensive care as needed.

Nonclinical Toxicology

No teratogenic effects have been identified in the available data. Similarly, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any additional insights. Furthermore, there is a lack of information concerning animal pharmacology and toxicology.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions in postmarketing experience reports. Symptoms of these reactions may 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 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 advised to exercise caution when 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 made aware of this risk.

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. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). For reference, 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 every 4 hours, with a maximum of 10 caplets in a 24-hour period. It is important to swallow the caplets whole and not to crush, chew, or dissolve them. For children under 12 years, consultation with a healthcare professional is advised before use.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional prior to using the medication. Additionally, information 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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