Allergy Multi Symptom

Description

RESTORE U is a multi-symptom allergy medication formulated for adults, containing Acetaminophen, Phenylephrine HCl, and Chlorpheniramine Maleate. This combination serves as a pain reliever, nasal decongestant, and antihistamine. It is indicated for the relief of headache, sinus pressure, nasal congestion, runny nose, sneezing, and itchy, watery eyes. The product may cause drowsiness. Each package contains 24 cool taste caplets, with the National Drug Code (NDC) 57344-928-02.

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, sinus congestion and pressure, minor aches and pains, runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes.

Additionally, this drug 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 and must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that the total dosage should not exceed 10 caplets 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. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should verify with a healthcare professional if they are unsure whether their prescription includes an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

Warnings and Precautions

This product contains acetaminophen, and it is crucial to adhere to the recommended dosage to prevent severe liver damage. The maximum daily dose is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. Liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen has the potential to cause severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

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

In the event of an overdose, it is critical to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion worsens or persists beyond 7 days; if fever intensifies or lasts more than 3 days; if redness or swelling occurs; or if new symptoms arise. These may be indicative of a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, or those who have stopped taking an MAOI within the last two weeks, should also avoid this product. Additionally, individuals with a history of allergic reactions to acetaminophen or any of its ingredients should refrain from use.

Patients are advised to consult a healthcare professional before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or respiratory issues such as emphysema or chronic bronchitis. It is also recommended that patients seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

While using this product, patients should adhere to the recommended dosage to avoid adverse effects. Excitability may occur, particularly in children, and drowsiness is a possible side effect. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery.

Patients should discontinue 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 fever worsens or lasts more than three days; if redness or swelling occurs; or if new symptoms arise, as these may indicate a serious condition.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. 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, and for a period of 2 weeks following the discontinuation of the MAOI. This interaction may lead to serious and potentially life-threatening side effects.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects of the medication, leading to increased drowsiness.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as there may be an increased risk of bleeding or other adverse effects.

It is important to note that the combined use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, which could impair the ability to perform tasks that require alertness. Monitoring for excessive sedation is advised in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Allergy Multi Symptom (acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride). 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. For dosing, adults and children aged 12 years and older are advised to take 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

Caution is warranted as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Geriatric patients, defined as individuals aged 65 years and older, have not been specifically addressed in the provided prescribing information regarding the use of this medication. There are no recommended age considerations, dosage adjustments, or safety concerns outlined for this population. Consequently, healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for efficacy and potential adverse effects is advised, given the lack of specific data on geriatric use.

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 drug 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, which contains acetaminophen. The maximum daily dose is limited to 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these individuals to prevent potential adverse effects associated with acetaminophen use.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt 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, vigilance and timely medical evaluation are essential in managing overdose situations effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. 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 keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with 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 cautioned against its use. They should be instructed to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be informed to discontinue use and consult a doctor if pain or nasal congestion worsens or persists beyond seven days, if fever intensifies or lasts more than three days, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and inform patients that excitability may occur, particularly in children. Drowsiness is a potential side effect, and patients should be warned that the use of alcohol, sedatives, or tranquilizers may enhance this effect. Patients should be advised to avoid alcoholic beverages while using this product and to exercise caution when driving or operating machinery.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should be encouraged to consult a doctor before using this product. Additionally, patients with breathing problems such as emphysema or chronic bronchitis, as well as those with glaucoma, should seek medical advice prior to use. Finally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It should be stored in a dry place at a temperature range of 20°-25°C (68°-77°F) to ensure optimal stability and efficacy. It is recommended to retain the carton for reference to complete product information.

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. Additionally, patients should be cautioned that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and they should avoid alcoholic beverages. Care should be taken when driving or operating machinery due to potential drowsiness.

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.

View product document (PDF)