Cold and Flu Hbp

Description

COLD & FLU HBP is a pharmaceutical product formulated to provide relief from symptoms associated with colds and flu, specifically for individuals with high blood pressure. Each tablet contains two active ingredients: Acetaminophen, which serves as a pain reliever and fever reducer, and Chlorpheniramine Maleate, an antihistamine. The product is presented in a dosage form of 20 tablets.

COLD & FLU HBP is indicated for the alleviation of symptoms such as runny nose, sneezing, body aches and pains, fever, and sore throat. The product is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895. It is important to note the tamper evident statement: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

This product is not manufactured or distributed by Bayer HealthCare LLC, the owner of the registered trademark Coricidin® HBP Cold & Flu. For further information, customers can visit CVS.com® or contact customer service at 1-800-SHOP CVS.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with common colds and allergies, including headache, sneezing, runny nose, minor aches and pains, and sore throat. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed. It is important not to exceed a total of 12 tablets within a 24-hour period.

For children aged 6 to under 12 years, the dosage is 1 tablet every 4 to 6 hours as required. The maximum allowable dosage for this age group is 5 tablets in a 24-hour period.

In children under 6 years of age, the use of this medication is not recommended unless directed by a physician.

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.

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

• Use in children for the purpose of inducing sleep, as this is not an approved indication and may pose safety risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults must not exceed 4,000 mg of acetaminophen within a 24-hour period, while children should not take more than 5 doses in the same timeframe. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen. Additionally, adults consuming 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may induce severe skin reactions, which can manifest as blisters, rash, or skin reddening. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists beyond 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

General precautions should be taken when considering this product. Patients should be instructed to consult a healthcare provider prior to use if they have difficulty urinating due to prostate gland enlargement, liver disease, respiratory issues such as emphysema or chronic bronchitis, or glaucoma. Furthermore, it is advisable for patients to seek guidance from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin.

In the event of an accidental overdose, immediate medical attention is essential. Patients should be directed to contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact their healthcare provider if pain worsens or persists beyond 5 days for children aged 6 to under 12 years, or 10 days for adults. Additionally, they should seek medical advice if new symptoms arise, if fever worsens or lasts more than 3 days, or if redness or swelling is observed.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than 5 doses in 24 hours, or if the product is used concurrently with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

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

Participants should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, medical consultation is advised.

Common adverse reactions may include excitability, particularly in children, and drowsiness. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery due to the potential for drowsiness.

Patients are instructed to stop use and consult a doctor if pain worsens or persists beyond five days for children aged 6 to under 12 years, or ten days for adults. Additionally, if new symptoms arise, fever worsens or lasts more than three days, or if redness or swelling is observed, medical advice should be sought.

Before using this product, patients should consult a doctor if they have difficulty urinating due to prostate gland enlargement, liver disease, breathing problems such as emphysema or chronic bronchitis, or glaucoma. Furthermore, it is advisable to consult a doctor or pharmacist if the patient is taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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.

Caution is advised when this medication is used in conjunction with sedatives or tranquilizers. Patients should consult a healthcare professional prior to use to assess the risk of enhanced sedation and drowsiness.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider before using this medication. The combination may necessitate monitoring for potential alterations in anticoagulation effects.

The concomitant use of alcohol, sedatives, and tranquilizers may potentiate drowsiness. Therefore, patients are advised to exercise caution and consider dosage adjustments or increased monitoring for sedation-related side effects when these substances are used together.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Flu Hbp (acetaminophen, chlorpheniramine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may take 1 tablet every 4 to 6 hours, with a maximum of 5 tablets in a 24-hour period. For children under 6 years, use is not recommended unless directed by a physician.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. If pain worsens or persists for more than 5 days in children aged 6 to under 12 years, it is advised to discontinue use and consult a doctor.

In the event of an accidental overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is essential. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before initiating treatment, as liver function may influence renal clearance and overall drug metabolism. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function 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. The following considerations are essential for this patient population:

Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period. For children, the risk increases if they take more than 5 doses in a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen can further elevate the risk of liver injury. Adults who consume 3 or more alcoholic drinks daily while using this product are also at an increased risk for liver damage.

It is imperative that patients with known liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and 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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, vigilance and timely intervention are essential in managing potential overdose situations effectively.

Nonclinical Toxicology

There is no available information regarding teratogenic or non-teratogenic effects. Additionally, no data is provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions, which may manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, cases of accidental overdose have been reported. In such instances, it is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an accidental overdose. Patients should be informed to contact a Poison Control Center or go to the nearest emergency room without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to refrain from using the product if the outer package is opened or if the blister is torn or broken. The expiration date and lot number can be found on the end flap of the packaging.

For optimal storage, the product should be maintained at a temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15°C to 30°C (59°F to 86°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

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