Cold and Flu

Description

Acetaminophen, a pain reliever and fever reducer, is included in the formulation alongside dextromethorphan HBr, which serves as a cough suppressant. Guaifenesin acts as an expectorant, while phenylephrine HCl functions as a nasal decongestant. The product is available in two sizes: 16 caplets and 8 caplets, with a total of 24 caplets per package. Chlorpheniramine maleate is also present as an antihistamine. The packaging is designed to be tamper-evident, and it is advised not to use the product if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is manufactured for Your Military Exchanges and distributed by LNK International, Inc., Hauppauge, NY 11788.

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 also aids in loosening phlegm (mucus) and thinning bronchial secretions to enhance cough productivity (for daytime use only) and assists in clearing nasal passages. Additionally, this drug provides cough relief 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 recommended to consult a physician before administration. Healthcare professionals should ensure that patients adhere to these guidelines to avoid exceeding the recommended dosage.

Contraindications

The concurrent use of DAYTIME and NIGHTTIME products is contraindicated. This combination may lead to an increased risk of adverse effects.

The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may result in serious drug interactions.

Additionally, this product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, due to the potential for acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Lastly, individuals with a known allergy to this product or any of its ingredients should avoid its use to prevent allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, diabetes, thyroid disease, heart disease, glaucoma (specifically for nighttime use), a cough associated with excessive phlegm, difficulty urinating due to prostate enlargement, high blood pressure, or a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be cautioned to seek advice from a doctor or pharmacist if they are taking warfarin, sedatives, or tranquilizers, particularly for nighttime use.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help right away, regardless of whether symptoms are present.

When to Stop Taking the Product Patients should discontinue use and contact their 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 lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other drugs containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical assistance immediately.

In clinical settings, patients have been cautioned to consult a doctor if they experience a severe sore throat that persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. Additionally, patients should stop use and consult a healthcare provider 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, or if redness or swelling is present. A return of cough or occurrence of cough with rash or headache that lasts may indicate a serious condition requiring medical evaluation.

When using this product, patients are advised not to exceed the recommended dosage. Notably, excitability and marked drowsiness may occur, particularly in children, when used at nighttime. Patients should avoid alcoholic beverages during this time, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving or operating machinery.

Patients with certain medical conditions, including liver disease, diabetes, thyroid disease, heart disease, glaucoma (specifically at nighttime), and high blood pressure, should consult a doctor before use. Additionally, those experiencing a cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. Patients taking the blood-thinning medication warfarin or sedatives and tranquilizers (especially at nighttime) should also consult a healthcare professional before using this product.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 and associated hepatotoxicity.

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, and for a period of two weeks following the discontinuation of the MAOI. This interaction may lead to severe hypertensive reactions.

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

Additionally, caution is advised for individuals using sedatives or tranquilizers, particularly at nighttime. The combination of this medication with alcohol, sedatives, or tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment of motor skills.

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 be advised to consult a healthcare professional before use. There is a potential for excitability and marked drowsiness to occur, particularly when used at nighttime. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information for this medication. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned in the text. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and overall health status.

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 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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, although specific recommendations are not provided.

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 the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the patient discontinue use and seek medical assistance immediately.

Additionally, healthcare professionals are encouraged to advise patients to stop using acetaminophen and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 7 days, if new symptoms arise, if fever worsens or lasts more than 3 days, if redness or swelling is observed, or if a cough recurs or is accompanied by a rash or headache that lasts. 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. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Additionally, healthcare providers should instruct patients not to take DAYTIME and NIGHTTIME products concurrently. This guidance is important to ensure safe and effective use of the medications.

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°-30°C (59°-86°F). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

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, a healthcare professional should be consulted for appropriate dosing.

Clinicians should counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding. Additionally, the medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is critical for both adults and children, regardless of the presence of symptoms. For information on the potential for medicine abuse among teens, resources are available at www.StopMedicineAbuse.org.

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.

View product document (PDF)