Allergy Multi-Symptom

Description

DG™|health Allergy Multi-Symptom is a combination medication formulated to relieve multiple allergy symptoms. The active ingredients include Acetaminophen, which serves as a pain reliever; Chlorpheniramine Maleate, an antihistamine; and Phenylephrine HCl, a nasal decongestant. This formulation is designed to alleviate headache, sinus pressure, nasal congestion, runny nose, sneezing, and itchy, watery eyes.

The product is presented in a dosage form of 24 caplets, featuring a Cool Blast flavor. It is important to note that this formulation is free of pseudoephedrine. The caplets are packaged with a tamper-evident warning, indicating that the product should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

DG™|health Allergy Multi-Symptom is distributed by Old East Main Co., located at 100 Mission Ridge, Goodlettsville, TN 37072.

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, as well as 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 older are instructed to take 2 caplets orally every 4 hours as needed. It is essential that the caplets are swallowed whole and not 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 advice 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 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 drinks 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 medical conditions. Prior to use, patients should consult a healthcare provider if they have a history of glaucoma, difficulty urinating due to prostate enlargement, high blood pressure, respiratory issues such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, or liver disease. Additionally, patients taking blood thinners such as warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

In cases of accidental overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) 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 7 days; if new symptoms arise; if fever worsens or lasts more than 3 days; or if redness or swelling occurs. These symptoms may indicate a serious underlying condition that requires medical 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 drugs containing acetaminophen, 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 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; 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 should adhere to the recommended dosage to avoid adverse effects. 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 or operating machinery due to the potential for drowsiness.

Patients with certain medical conditions should consult a healthcare provider before use. These conditions include glaucoma, difficulty urinating due to prostate enlargement, high blood pressure, breathing problems such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, and liver 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 case of accidental overdose, it is crucial for patients to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are 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, as well as for a period of two weeks following the discontinuation of an MAOI. This interaction 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 pharmacodynamic interactions.

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 Allergy Multi-Symptom (acetaminophen, chlorpheniramine maleate and 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

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, 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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain 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, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of 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 accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Timely 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 following an overdose incident.

Management of overdose cases should include supportive care and symptomatic treatment as necessary, tailored to the specific circumstances and clinical presentation of the patient.

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. 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 (1-800-222-1222) in the event of an accidental overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are initially 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 use of alcohol, sedatives, and tranquilizers, as these substances may enhance drowsiness. Patients are advised to avoid alcoholic beverages while taking this medication.

Additionally, healthcare providers should remind patients to exercise caution when driving a motor vehicle or operating machinery, as drowsiness may occur. It is essential for patients to understand the potential impact of the medication on their ability to perform these activities safely.

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.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). 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 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for 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 accidental overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, 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 Allergy Multi-Symptom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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