Multi-Symptom Cold

Description

Best Choice Cold Multi-Symptom is a combination medication formulated to provide relief from multiple cold symptoms. Each caplet contains the following active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; chlorpheniramine maleate, an antihistamine; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant.

This product is indicated for the relief of headache, fever, sore throat, runny nose, nasal congestion, and cough. It is formulated as a blister pack containing 24 caplets and is free from pseudoephedrine. 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.

Best Choice Cold Multi-Symptom is distributed by Associated Wholesale Grocers, Inc., located in Kansas City, Kansas 66106. Additional product information can be found at bestchoicebrand.com/62372.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, sore throat, nasal congestion, sneezing, runny nose, headache, cough, and sinus congestion and pressure. It aids in clearing nasal passages and provides cough relief to facilitate sleep. Additionally, this drug temporarily reduces fever.

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 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 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, 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 significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while using this product.

Patients should be alerted to the potential for severe skin reactions associated with acetaminophen. Symptoms such as blisters, rash, and skin reddening may indicate a serious allergic reaction. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

General precautions must be emphasized to patients. They should not exceed the recommended dosage, as marked drowsiness may occur. The use of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, and patients are advised to avoid alcoholic beverages while taking this product. Additionally, excitability may be observed, particularly in children, and caution should be exercised when driving or operating machinery.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help right away, regardless of whether symptoms are present.

Patients should also be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should seek medical advice if pain, nasal congestion, or cough 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. A return of cough accompanied by rash or headache that lasts may indicate a serious condition requiring prompt evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed 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.

Patients should be aware of the risk of 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. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or lasts longer than seven days, if new symptoms arise, if fever worsens or persists beyond three days, or if redness or swelling is observed. A cough that recurs or occurs alongside a rash or headache that lasts may indicate a serious condition requiring medical evaluation.

While using this product, patients may experience marked drowsiness, which can be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. It is recommended to avoid alcoholic beverages during use. Additionally, excitability may occur, particularly in children, and caution is advised when driving or operating machinery.

Patients are strongly cautioned not to exceed the recommended dosage to mitigate the risk of adverse reactions.

Drug Interactions

Concurrent use of this medication with other products 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 conditions such as depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. This combination may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential 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 Multi-Symptom Cold (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, 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. For adolescents 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.

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 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 exercise caution when using this medication. It is advisable for patients with reduced kidney function to consult a healthcare professional prior to use, particularly if they have liver disease. Additionally, patients experiencing difficulty in urination due to prostate gland enlargement should be cautious when driving a motor vehicle or operating machinery. Regular monitoring and appropriate dosing adjustments may be necessary based on individual renal function.

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 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 health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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 the following adverse reactions associated with acetaminophen use: severe skin reactions, including blisters, rash, and skin reddening. These events have been reported voluntarily or through surveillance programs.

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 initially apparent.

Patients should be instructed not to exceed the recommended dosage. They should be made aware that marked drowsiness may occur and that the consumption of alcohol, sedatives, and tranquilizers can exacerbate this drowsiness. Therefore, it is advisable for patients to avoid alcoholic beverages while using this medication.

Healthcare providers should inform patients that excitability may occur, particularly in children, and caution should be exercised when driving a motor vehicle or operating machinery. Patients should be advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Patients should also be instructed to stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than 7 days. Additionally, they should be advised to consult a doctor if new symptoms arise, if fever worsens or lasts more than 3 days, or if there is any redness or swelling present. Patients should be particularly vigilant and seek medical attention if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

Before using this medication, patients should be encouraged to consult a doctor if they have a persistent or chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). Furthermore, patients with liver disease, thyroid disease, diabetes, glaucoma, heart disease, high blood pressure, or difficulty urinating due to prostate enlargement should also seek medical advice prior to use.

Lastly, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin or if they are using sedatives or tranquilizers, to ensure safe and effective use of this medication.

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.

For optimal storage, the product must be kept at a temperature of 25°C (77°F). However, excursions are permitted within a range of 15° to 30°C (59° to 86°F). Proper handling and storage conditions are essential to maintain the integrity of the product.

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, consultation with a healthcare professional is advised before use.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional prior to using this medication. Additionally, information regarding the potential for medicine abuse, particularly among teenagers, can be found at www.StopMedicineAbuse.org. No further details are available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)