Multi-Symptom Allergy

Description

NDC 0363-0559-08. This product is a multi-symptom allergy medication distributed by Walgreen Co., located at 200 Wilmot Rd., Deerfield, IL 60015. Each gelcap contains 325 mg of acetaminophen, serving as a pain reliever; 2 mg of chlorpheniramine maleate, functioning as an antihistamine; and 5 mg of phenylephrine HCl, acting as a nasal decongestant. The formulation is designed to provide relief from symptoms including runny nose, sneezing, itchy and watery eyes, and itchy throat or nose. The product is packaged in a tamper-evident container, and should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. Each package contains 24 gelcaps.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hay fever and other upper respiratory allergies. These symptoms include runny nose, sneezing, nasal congestion, minor aches and pains, headache, and 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 medication.

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 gelcaps every 4 hours as needed. It is imperative that they do not exceed a maximum of 10 gelcaps 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 there is uncertainty regarding 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 treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

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

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the following conditions are met: 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.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a physician prior to use if they have any of the following conditions: breathing problems such as emphysema or chronic bronchitis, high blood pressure, heart disease, diabetes, liver disease, difficulty urinating due to prostate gland enlargement, glaucoma, or thyroid disease. Additionally, patients should be cautioned to seek guidance from a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives and tranquilizers.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should also be advised to discontinue use 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 liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using the product. Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use and seek medical assistance immediately.

Patients should stop using 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 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 should exercise caution when driving or operating machinery. It is also recommended to avoid alcoholic beverages during use.

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

In the event of an overdose, it is critical for patients 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 initially apparent.

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 two weeks following the discontinuation of the 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 due to potential pharmacodynamic interactions.

Additionally, caution is advised for individuals using sedatives or tranquilizers in conjunction with this medication. The combination may enhance the sedative effects, leading to increased drowsiness. Monitoring for excessive sedation is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Multi-Symptom 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 use. There is a potential for excitability to occur, particularly in children. Caution is advised when administering this medication to pediatric populations.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. The absence of recommended age considerations, dosage adjustments, safety concerns, or special precautions indicates that the data does not highlight any particular risks or modifications for this population.

Healthcare providers should remain vigilant when prescribing this medication to geriatric patients, considering the general principles of pharmacotherapy in older adults, including potential changes in pharmacokinetics and pharmacodynamics. Regular monitoring and assessment of therapeutic outcomes are advisable to ensure safety and efficacy in this demographic.

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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day 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 therapy.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No teratogenic effects were identified in the studies conducted. Additionally, there were no non-teratogenic effects reported. The available data does not provide any details regarding nonclinical toxicology or animal pharmacology and toxicology.

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 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 apparent.

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 medication contains 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 drowsiness is a possible side effect. Patients should be cautioned against consuming alcohol, sedatives, or tranquilizers while using this product, as these may enhance drowsiness.

Healthcare providers should advise patients to exercise caution when driving or operating machinery while using this product. Additionally, patients should be encouraged to consult a doctor before use if they have any of the following conditions: breathing problems such as emphysema or chronic bronchitis, high blood pressure, heart disease, diabetes, liver disease, difficulty urinating due to prostate enlargement, glaucoma, or thyroid disease.

Finally, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should be advised to consult a doctor or pharmacist before using this product.

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°C and 30°C (59°F to 86°F). It is important to avoid high humidity during storage. For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 gelcaps every 4 hours, with a maximum of 10 gelcaps in a 24-hour period. For children under 12 years, it is advised to consult a doctor regarding appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should obtain medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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