Allergy

Description

No description information is available for the specified drug.

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, nasal congestion, runny nose, sneezing, minor aches and pains, sinus congestion, and pressure. Additionally, it provides relief from itchy, watery eyes and itching of the nose or throat.

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 every 4 hours as needed. The caplets should be swallowed whole; they must not be crushed, chewed, or dissolved. It is imperative that no more than 10 caplets are taken within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician 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) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. Patients should verify with a healthcare professional if their current medications include an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe hypersensitivity reactions.

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 risk increases with the following conditions: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Patients should also be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include blisters, rash, and skin reddening. In the event of any skin reaction, patients must 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 any of the following: difficulty urinating due to prostate enlargement, high blood pressure, respiratory issues such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, liver disease, or glaucoma. 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 accidental overdose, it is imperative to seek emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to stop taking the product and consult a healthcare provider 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 occurs. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed a dosage of 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. Additionally, patients should be aware of the risk of severe skin reactions, 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.

Patients are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Furthermore, worsening pain or nasal congestion lasting more than seven days, the emergence of new symptoms, or a fever that worsens or persists beyond three days, along with any signs of redness or swelling, may indicate a serious condition requiring medical evaluation.

During the use of this product, it is crucial for patients to adhere to the recommended dosage to avoid adverse effects. Excitability may occur, particularly in children, and the concomitant use of alcohol, sedatives, or tranquilizers may enhance drowsiness. Patients should avoid alcoholic beverages and exercise caution when driving or operating machinery, as drowsiness may occur.

Patients with certain pre-existing conditions should consult a healthcare provider prior to use. These conditions include difficulty in urination due to prostate enlargement, high blood pressure, respiratory issues such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, liver disease, and glaucoma. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Allergy (acetaminophen, chlorpheniramine maleate, 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 using this product. When administered, excitability may occur, particularly in children.

For dosing, adults and children aged 12 years and older are directed to take 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. Specific dosing recommendations for children under 12 years require consultation with a doctor.

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

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

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

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention 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, vigilance and timely intervention are essential in managing overdose situations effectively.

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 that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can 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 accidental 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 exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that excitability may occur, particularly in children, and they should be made aware of this possibility.

Providers should caution patients about the potential for increased drowsiness when consuming alcohol, sedatives, or tranquilizers in conjunction with this medication. Therefore, patients should be advised to avoid alcoholic beverages while using this medication.

Additionally, healthcare providers should recommend that patients exercise caution when driving a motor vehicle or operating machinery, as drowsiness may occur. It is essential for patients to understand the importance of these precautions to ensure their safety and well-being.

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 who are pregnant or breastfeeding to seek advice from a health professional before using the medication. Additionally, it is crucial to keep the medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)