Allergy Sinus, Lil Drug Store

Description

Allergy Sinus is a combination medication formulated to address sinus congestion and pressure, nasal congestion, and symptoms such as runny nose and sneezing. The active ingredients include acetaminophen, a pain reliever; chlorpheniramine maleate, an antihistamine; and phenylephrine hydrochloride, a nasal decongestant. This medication is presented in tablet form, with packaging options that include pouches containing 6 tablets or 2 tablets.

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 headache, sinus congestion and pressure, nasal congestion, runny nose, sneezing, minor aches and pains, as well as itching of the nose or throat and itchy, watery eyes.

Additionally, this drug 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 tablets every 4 to 6 hours as needed. The total dosage should not exceed 12 tablets within a 24-hour period unless directed otherwise by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

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 there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. This contraindication extends for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI before using this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to minimize the risk of liver injury:

• Do not exceed 4,000 mg of acetaminophen within a 24-hour period, as this is the maximum recommended daily dosage.

• Avoid concurrent use with other medications containing acetaminophen, whether prescription or over-the-counter.

• Limit alcohol consumption to fewer than three drinks per day while using this product, as increased alcohol intake can exacerbate the risk of liver damage.

Acetaminophen may also cause severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

In addition to the above warnings, several general precautions should be observed:

• Patients should not use this product in conjunction with any other drug containing acetaminophen. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare provider is recommended.

• The product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Healthcare professionals should confirm whether any prescribed drugs contain an MAOI before advising the use of this product.

• Prior to use, patients should consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, glaucoma, diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis.

• Patients taking sedatives, tranquilizers, or the anticoagulant warfarin should also seek medical advice before using this product.

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 without delay, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain or nasal congestion lasting more than seven days; fever that worsens or persists beyond three days; any signs of redness or swelling; or the emergence of new symptoms, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume 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 skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson’s disease, or those who have stopped taking an MAOI within the past two weeks, should also avoid this product. If there is uncertainty regarding the presence of an MAOI in a prescription drug, patients are advised to consult a doctor or pharmacist.

Prior to using this product, patients should consult a healthcare professional if they have liver disease, heart disease, glaucoma, diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a breathing problem such as emphysema or chronic bronchitis. Additionally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek medical advice before use.

While using this product, patients should adhere to the recommended dosage to avoid adverse effects. Excitability may occur, particularly in children, and drowsiness is a possible side effect. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; or if new symptoms arise, as these may indicate a serious condition.

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 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, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects, including hypertensive crises.

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 interactions.

Caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness and impair cognitive and motor functions. Monitoring for increased sedation and potential respiratory depression is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Allergy Sinus, Lil Drug Store (acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to using this product. Caution is advised as excitability may occur, particularly in children.

Geriatric Use

There is no specific information 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.

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 safe use during pregnancy and lactation.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data may necessitate individualized assessment and monitoring based on clinical judgment.

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

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions 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 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 adverse effects. Therefore, monitoring and evaluation should be conducted as soon as possible to ensure patient safety and appropriate management.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can 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 keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial 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 present.

Patients should be instructed not to exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that excitability may occur, particularly in children, and that drowsiness is a possible side effect. They should be cautioned that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and therefore, patients are advised to avoid alcoholic beverages while taking this medication.

Additionally, patients should be made aware of the need for caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. Healthcare providers should encourage patients to consult with a doctor before using the medication if they have any of the following conditions: liver disease, heart disease, glaucoma, diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a breathing problem such as emphysema or chronic bronchitis.

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, maintaining a range of 59-86°F (15-30°C). Care should be taken to avoid exposure to excessive heat and humidity to ensure the integrity of the product. Proper storage conditions are crucial for maintaining the product's efficacy and safety.

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 Allergy Sinus, Lil Drug Store, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)