Facol Cold and Flu Day

Description

Facol® Cold and Flu Day is a multi-ingredient formulation provided in a soft liquid-filled capsule dosage form. Each capsule contains the following active ingredients: guaifenesin, an expectorant; acetaminophen, a fever and pain reducer; phenylephrine hydrochloride, a nasal decongestant; and dextromethorphan hydrobromide, a cough suppressant. The product is packaged in a bottle containing 10 capsules and is manufactured by JW Pharmaceuticals. The National Drug Code (NDC) for this product is 69365-001-01.

Uses and Indications

This drug is indicated for the relief of mild to moderately severe pain. Additionally, it temporarily reduces multiple cold symptoms.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children aged 15 years and older are instructed to take 2 capsules after each meal, administered twice daily. It is essential that the capsules are swallowed whole; they must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication.

Healthcare professionals should advise patients not to take the nighttime capsule less than 6 hours after the daytime capsule to maintain appropriate dosing intervals.

For children under 15 years of age, the use of this medication is not recommended without consulting a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

• In children younger than 3 months of age due to the risk of adverse effects in this vulnerable population.

• In individuals with a known allergy to this product or any of its ingredients, as this may lead to severe allergic reactions.

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated to prevent the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, due to the potential for serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which necessitates careful consideration of liver health. The maximum recommended daily dosage is 10 caplets within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Healthcare professionals should advise patients to consult a physician prior to use if they have any of the following conditions: liver disease, asthma, chronic bronchitis, emphysema, thyroid disease, heart disease, diabetes, glaucoma, or high blood pressure. Additionally, it is prudent to seek guidance from a doctor or pharmacist if the patient is currently taking sedatives or tranquilizers, has chickenpox or other infections, or is using the anticoagulant warfarin.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any of the following: nervousness, dizziness, sleeplessness, or constipation; signs of redness or swelling; worsening fever lasting more than three days; or the emergence of new severe symptoms, including shock (anaphylaxis), Stevens-Johnson syndrome, Lyell syndrome, asthma, dyshepatia, or interstitial lung diseases. Furthermore, if pain, cough, or nasal congestion worsens or persists after five to six doses, medical advice should be sought.

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

Severe liver damage may occur 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.

Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, sleeplessness, or constipation. Additionally, they should seek medical advice if redness or swelling occurs, if fever worsens or persists beyond three days, or if new severe symptoms arise, including shock (anaphylaxis), Stevens-Johnson Syndrome, Lyell Syndrome, asthma, dyshepatia, or interstitial lung diseases. Patients should also contact a doctor if pain, cough, or nasal congestion worsens or continues after five to six doses.

It is recommended that patients consult a healthcare provider before using this product if they have a history of liver disease, asthma, chronic bronchitis, emphysema, thyroid disease, heart disease, diabetes, glaucoma, or high blood pressure. Furthermore, patients should inform their doctor or pharmacist if they are taking sedatives or tranquilizers, have chickenpox or other infections, or are using the blood-thinning medication warfarin.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers. The combination may enhance sedative effects, leading to increased drowsiness or respiratory depression.

Additionally, individuals on anticoagulant therapy with warfarin should seek advice from a healthcare provider before initiating this medication. There is a potential for altered anticoagulant effects, which may necessitate monitoring of INR levels and possible dosage adjustments.

This medication is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. Use is also prohibited for a period of two weeks following the discontinuation of an MAOI due to the risk of serious interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Facol Cold and Flu Day (acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 15 years of age should not use this medication without consulting a healthcare professional. Additionally, the use of this medication is contraindicated in infants younger than 3 months old. It is essential for healthcare providers to consider these age-related restrictions when prescribing this treatment to ensure patient safety.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not take this drug without consulting a healthcare professional. The potential risks associated with the use of this medication during pregnancy or lactation have not been fully established. Therefore, it is crucial for women of childbearing potential to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

Lactating mothers are advised against the use of this drug while breastfeeding. It is recommended that they consult a health professional for guidance. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum daily dose for all patients is 10 caplets within a 24-hour period. However, it is critical to note that severe liver damage may occur if the total daily intake of acetaminophen exceeds 4,000 mg.

Additionally, patients with compromised liver function should be aware that the risk of severe liver damage increases if this product is taken concurrently with other medications containing acetaminophen. Furthermore, the consumption of three or more alcoholic drinks daily while using this product may also lead to severe liver damage.

Due to these risks, it is advisable for patients with hepatic impairment to consult a healthcare professional for individualized dosing recommendations and to discuss any potential interactions with other medications or substances. Regular monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative that healthcare professionals act swiftly to ensure patient safety. The recommended action is to seek immediate medical assistance or contact a Poison Control Center at 1-800-333-2333.

To prevent the risk of overdose, it is crucial to adhere strictly to the recommended dosage guidelines. Exceeding the prescribed dose can lead to serious health complications. Therefore, vigilance in monitoring dosage is essential for patient safety.

Healthcare providers should be prepared to assess the patient for potential symptoms associated with overdose, which may vary depending on the specific substance involved. Prompt recognition and management of these symptoms are vital in mitigating adverse effects and ensuring appropriate care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, sleeplessness, or constipation. Additionally, the presence of redness or swelling warrants medical attention.

Reports indicate that if fever worsens or persists beyond three days, or if new severe symptoms arise—such as shock (anaphylaxis), Stevens-Johnson Syndrome, Lyell Syndrome, asthma, dyshepatia, or interstitial lung diseases—medical advice should be sought immediately. Furthermore, if pain, cough, or nasal congestion intensifies or continues after five to six doses, patients are encouraged to contact their healthcare provider.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and to refrain from using it in children younger than 3 months old. Patients should be informed not to use the product if they have a history of allergic reactions to it or any of its ingredients.

It is essential to counsel patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

Patients should also be cautioned not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, sleeplessness, or constipation. Additionally, patients should be advised to seek medical attention if they notice redness or swelling, if a fever worsens or persists beyond three days, or if new severe symptoms arise, such as shock (anaphylaxis), Stevens-Johnson Syndrome, Lyell Syndrome, asthma, dyshepatia, or interstitial lung diseases. Patients should also be informed to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts after 5-6 doses.

When using this product, patients must not exceed the recommended dose and should avoid consuming alcohol during treatment. Healthcare providers should recommend that patients consult a doctor before use if they have liver disease, asthma, chronic bronchitis, emphysema, thyroid disease, heart disease, diabetes, glaucoma, or high blood pressure. Furthermore, patients should be advised to speak with a doctor or pharmacist before use if they are taking sedatives or tranquilizers, are experiencing chickenpox or other infections, or are taking the blood-thinning medication warfarin.

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 room temperature, ideally between 20-25°C (68-77°F). Care should be taken to avoid exposure to direct light, humid conditions, and excessive heat to maintain the integrity of the product. Proper storage conditions are crucial for ensuring the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)