Flonase

Description

FLONASE (NDC 0135-0578-03) is a combination formulation designed for headache and allergy relief. Each caplet contains 325 mg of acetaminophen, serving as a pain reliever and fever reducer; 2 mg of chlorpheniramine maleate, an antihistamine; and 5 mg of phenylephrine HCl, a nasal decongestant. The product is presented in a package containing 96 caplets, providing fast relief from allergy symptoms, headache pain, and nasal congestion.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hay fever or other upper respiratory allergies. These symptoms include sinus congestion and pressure, runny nose, sneezing, minor aches and pains, nasal congestion, and headache. Additionally, it provides relief from itching of the nose or throat and itchy, watery eyes.

This drug also aids in clearing nasal passages and decongesting sinus openings and passages.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets orally every 4 to 6 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

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.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen and the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should consult a healthcare provider if they have difficulty urinating due to prostate enlargement, high blood pressure, respiratory issues such as emphysema or chronic bronchitis, heart disease, liver disease, thyroid disease, glaucoma, or diabetes. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking blood thinners, such as warfarin, or sedatives and tranquilizers.

In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain or nasal congestion worsens or persists beyond seven days, if new symptoms arise, if fever intensifies or lasts more than three days, or if redness or swelling occurs, these may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if they take more than 4,000 mg within a 24-hour period, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness, if pain or nasal congestion worsens or persists beyond seven days, if new symptoms arise, if fever intensifies or lasts more than three days, or if redness or swelling is observed, as these may indicate a serious condition.

While using this product, it is crucial not to exceed the recommended dosage. Patients may experience excitability, particularly in children, and should be cautious as alcohol, sedatives, and tranquilizers can enhance drowsiness. It is recommended to avoid alcoholic beverages and to exercise caution when driving or operating machinery, as drowsiness may occur.

Additional considerations include consulting a healthcare provider prior to use if patients have conditions such as difficulty urinating due to prostate enlargement, high blood pressure, respiratory issues like emphysema or chronic bronchitis, heart disease, liver disease, thyroid disease, glaucoma, or diabetes. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking blood-thinning medications such as warfarin or if they are using sedatives or tranquilizers.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential 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 2 weeks following the discontinuation of an MAOI. This interaction may lead to serious and potentially life-threatening side effects.

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 individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation and potential respiratory depression is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Flonase (acetaminophen, chlorpheniramine maleate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should consult a healthcare professional before use. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4-6 hours, with a maximum of 10 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in pediatric patients. It is essential for both adults and children to seek prompt medical attention, even in the absence of noticeable signs or symptoms.

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, given the lack of targeted data for this population.

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 the safety of both the mother and the developing fetus.

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 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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period, particularly when taking other medications that also contain acetaminophen or consuming three or more alcoholic drinks daily 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 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 appropriate care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include blisters, rash, and skin reddening. 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, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

Patients should be informed not to use 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.

It is essential to instruct patients 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. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should also inform patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should be advised to stop using the product and seek medical advice if pain or nasal congestion worsens or persists for more than seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if redness or swelling occurs, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Patients should be advised to avoid alcoholic beverages while using this product and to exercise caution when driving or operating machinery due to the potential for drowsiness.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, high blood pressure, breathing problems such as emphysema or chronic bronchitis, heart disease, liver disease, thyroid disease, glaucoma, or diabetes. Additionally, patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should be advised to seek guidance from a doctor or pharmacist prior to use.

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 room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

View product document (PDF)