Allergy Multi-Symptom

Description

✓select™ is a combination medication formulated as caplets, containing the active ingredients acetaminophen, chlorpheniramine maleate, and phenylephrine HCl. This product is indicated for the relief of pain, as well as for its antihistamine and nasal decongestant properties. It is specifically used to alleviate symptoms associated with headache, runny nose, sinus pressure, sneezing, nasal congestion, and itchy, watery eyes. Each package contains 24 caplets.

The product is manufactured for Military Exchanges and distributed by LNK International, Inc., located in Hauppauge, NY 11788. A tamper evident warning is included, stating 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. For customer inquiries, a service phone number is provided: 1-800-426-9391.

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 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:

• 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 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 any of the following conditions: difficulty urinating due to prostate gland enlargement, glaucoma, high blood pressure, respiratory issues such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, or liver disease. 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 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 seven days, if new symptoms arise, if fever intensifies or lasts more than three days, or if redness or swelling occurs, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur if patients 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, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for certain symptoms that warrant discontinuation of the product and consultation with a healthcare provider. These include nervousness, dizziness, or sleeplessness; worsening pain or nasal congestion lasting more than seven days; the emergence of new symptoms; fever that worsens or persists for more than three days; and any signs of redness or swelling. Such symptoms may indicate a serious underlying condition that requires medical evaluation.

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. 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

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 no specific data available regarding the excretion of this medication in 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 absence of guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, particularly if taken in conjunction with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to use to assess the appropriateness of this product and to discuss potential risks associated with acetaminophen use in the context of their liver function. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

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

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may 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, 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 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 encouraged to ask their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should be informed 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 should be cautioned not to exceed the recommended dosage. They should also be made aware that excitability may occur, particularly in children. Additionally, patients should be advised that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and they should avoid alcoholic beverages while using this product.

Patients should exercise caution when driving or operating machinery, as drowsiness may occur. Healthcare providers should recommend that patients consult a doctor before using this product if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, glaucoma, high blood pressure, breathing problems such as emphysema or chronic bronchitis, heart disease, thyroid disease, diabetes, or liver disease. Furthermore, patients should be advised to consult a doctor or pharmacist if they are 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.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). For reference, the expiration date and lot number can be found on the end flap of the packaging.

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 to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, 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 Multi-Symptom, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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