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:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek guidance from a healthcare professional.

• In individuals with a known allergy to this product or any of its ingredients, due to the risk of severe allergic 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 maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic beverages daily while taking this product.

Patients should also be made aware of the potential for severe skin reactions associated with acetaminophen use. 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 medical 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, 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 obtain 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. They should also seek medical advice if pain or nasal congestion worsens or persists beyond seven days, if new symptoms arise, or if fever intensifies or lasts more than three days. The presence of redness or swelling should also prompt immediate medical consultation, as these may indicate a serious underlying 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 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 associated with acetaminophen, which may manifest as blisters, rash, or skin reddening. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance immediately.

Patients should stop using this product 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 worsens or lasts more than three days; or if redness or swelling is observed, as these may indicate a serious condition.

While using this product, patients are cautioned not to exceed the recommended dosage. Excitability may occur, particularly in children. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Patients should consult a healthcare provider prior to use if they have difficulty urinating due to prostate gland enlargement, high blood pressure, breathing problems such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, liver disease, or glaucoma. Additionally, patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

Drug Interactions

Acetaminophen has the potential to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently.

Concomitant use of alcohol, sedatives, and tranquilizers with this product may lead to increased drowsiness. Caution is advised when these substances are taken together, and patients should be monitored for enhanced sedation effects.

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.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older, due to the increased likelihood of comorbidities and the potential for adverse effects. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have any of the following conditions: difficulty in urination due to prostate gland enlargement, high blood pressure, respiratory issues such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, liver disease, or glaucoma.

Additionally, elderly patients should seek guidance from a doctor or pharmacist if they are currently taking anticoagulants such as warfarin or any sedatives or tranquilizers, as these medications may interact with the product.

While using this product, geriatric patients should be aware that alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when driving or operating machinery, as drowsiness may occur.

Elderly patients are encouraged to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain or nasal congestion worsens or persists beyond 7 days, if new symptoms arise, if fever intensifies or lasts more than 3 days, or if there is any redness or swelling.

For those who are pregnant or breastfeeding, it is essential to consult a health professional before use. Furthermore, this product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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

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.

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 for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to cumulative dosing and increase the risk of liver damage.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the potential for liver injury.

Additionally, patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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 are advised to remain vigilant and proactive in managing potential overdose situations. Early intervention can significantly impact the outcome, underscoring the importance of timely communication with medical authorities.

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. Reported symptoms of these reactions include blisters, rash, and skin reddening. In the event of a skin reaction, it is advised to discontinue use of the medication and seek medical assistance immediately.

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, as prompt medical attention is critical 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. Therefore, patients should be cautioned against consuming alcoholic beverages, as well as sedatives and tranquilizers, which may enhance drowsiness.

Providers should emphasize the importance of using caution when driving a motor vehicle or operating machinery due to the risk of drowsiness.

Patients should be encouraged to consult with their healthcare provider before use if they have any of the following conditions: difficulty in urination due to enlargement of the prostate gland, high blood pressure, breathing problems such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, liver disease, or glaucoma.

Additionally, patients should be advised to speak with their doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

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, with a recommended dosage of 2 caplets every 4 hours, not to exceed 10 caplets within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

It is crucial to keep the medication out of reach of children. In the event of an accidental overdose, patients must seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

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.

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