Cough and Cold Plus

Description

Cough and Cold plus Capsules are formulated as softgels, each containing a combination of active ingredients: Acetaminophen (325 mg), Phenylephrine HCl (5 mg), Chlorpheniramine Maleate (2 mg), and Dextromethorphan HBr (10 mg). This product is available in a quantity of 4000 capsules. The National Drug Code (NDC) for this formulation is 53345-045-01. The product is manufactured in China.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. These symptoms include minor aches and pains, headache, nasal and sinus congestion, cough, runny nose, sneezing, and sore throat. 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 advised to take 2 softgels with water every 4 hours as needed. The total daily dosage should not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. It is imperative that patients adhere to the recommended dosage and not exceed the specified limits to ensure safety and efficacy.

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 interactions. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

• Use in children under 12 years of age is contraindicated due to safety concerns.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they exceed the maximum daily dosage of 10 softgels within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while taking this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to 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 advised to consult a physician promptly. Additionally, this product is not intended for use as a sedative in children.

Healthcare professionals should recommend that patients consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, or persistent cough associated with smoking, asthma, or emphysema. Furthermore, patients should be cautioned to seek advice from a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives and tranquilizers.

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 without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should also be advised to discontinue use and contact their healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever worsening or persisting beyond three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache lasting; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious underlying condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may 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.

A sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts longer than seven days, if fever worsens or persists beyond three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition. Additionally, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

While using this product, patients may experience marked drowsiness and should avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution is advised when driving or operating machinery. Excitability may also occur, particularly in children.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic respiratory issues should consult a doctor before use. Those experiencing difficulty urinating due to prostate enlargement or persistent coughs associated with smoking, asthma, or emphysema should also seek medical advice prior to use.

It is important for patients to consult a doctor or pharmacist if they are taking blood-thinning medications such as warfarin or sedatives and tranquilizers.

This product should not be used in conjunction with any other drug containing acetaminophen, by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication, or by those with a known allergy to this product or any of its ingredients. It is contraindicated for use in children under 12 years of age.

Patients should keep this product out of reach of children. In the event of an overdose, immediate medical attention is critical 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 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 Cough and Cold Plus (acetaminophen, phenylephrine hcl, chlorpheniramine maleate, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. It is contraindicated for sedation in children. Prior to use, healthcare professionals should be consulted if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, or persistent or chronic cough associated with smoking, asthma, or emphysema.

While using this product, there is a potential for excitability, particularly in children. It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 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 lack of data 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. Severe liver damage may occur if patients exceed the maximum daily dosage of 10 softgels within a 24-hour period. This limit applies not only to the product itself but also to the total intake of acetaminophen from all sources, including other medications that contain acetaminophen. Additionally, patients should be aware that consuming three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

It is recommended that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action 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 severe skin reactions associated with the use of acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. Reports of these adverse reactions have been received voluntarily and through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be instructed not to exceed the recommended dosage to avoid potential adverse effects. It is important to inform patients that the medication may cause marked drowsiness, and they should be cautioned against consuming alcoholic beverages while taking it. Additionally, patients should be made aware that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Healthcare providers should emphasize the need for caution when driving a motor vehicle or operating machinery due to the potential for drowsiness. Furthermore, patients should be informed that excitability may occur, particularly in children, and they should monitor for any unusual behavioral changes.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15° to 30°C (59°F to 86°F). Care should be taken to avoid exposure to excessive heat to maintain product integrity.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels taken with water every 4 hours, with a maximum of 10 softgels in a 24-hour period unless otherwise directed by a healthcare professional. Use is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult 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, immediate medical assistance should be sought, and contacting a Poison Control Center is advised, 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 Cough and Cold Plus, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)