Cold and Flu Hbp

Description

This product contains two active ingredients: acetaminophen, a pain reliever and fever reducer, and chlorpheniramine maleate, an antihistamine. It is indicated for individuals with high blood pressure and is designed to relieve symptoms such as runny nose, sneezing, body aches and pains, fever, and sore throat. The product is packaged in a blister pack containing 20 tablets, with each tablet being of actual size.

The packaging includes a tamper-evident statement, indicating 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. This product is distributed by Meijer Distribution, Inc., located in Grand Rapids, MI 49544, and is not manufactured or distributed by Bayer HealthCare LLC, the owner of the registered trademark Coricidin® HBP COLD & FLU. For more information, visit www.meijer.com.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with common colds and allergies, including headache, sore throat, sneezing, minor aches and pains, and runny nose. Additionally, it temporarily reduces 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, with a maximum 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, not to exceed 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.

It is essential for healthcare professionals to ensure that patients adhere to the specified dosing intervals and maximum daily limits to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a history of allergic reactions to this product or any of its components.

• The product is not intended for use in children for the purpose of inducing sleepiness.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than 5 doses in 24 hours, if it is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients should consult a doctor or pharmacist prior to use if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

In the event of an accidental overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

Patients should discontinue use and contact their healthcare provider if any of the following occur: pain worsens or persists beyond 5 days for children aged 6 to under 12 years, or beyond 10 days for adults; new symptoms arise; fever worsens or lasts more than 3 days; or if redness or swelling is observed.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage of 4,000 mg in 24 hours for adults or 5 doses in 24 hours for children. The risk is further heightened if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 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 blisters, rash, or skin reddening. 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 worsens or lasts longer than five days in children aged 6 to under 12 years, or ten days in 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 with difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or breathing problems such as emphysema or chronic bronchitis should consult a healthcare professional. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek guidance from a doctor or pharmacist prior to use.

While using this product, patients may experience excitability, particularly in children. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating caution when driving or operating machinery. Drowsiness may occur, and it is advisable to avoid alcoholic beverages.

In the case of accidental overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Before initiating treatment, it is advisable for patients to consult with a healthcare professional if they are concurrently using sedatives or tranquilizers. The combination of these substances may enhance drowsiness, potentially leading to increased sedation and impaired cognitive function.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider prior to use. The interaction between this blood-thinning medication and the drug in question may necessitate careful monitoring of coagulation parameters to ensure patient safety.

There are no specific laboratory test interactions identified in the available data.

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 be administered 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.

Caution is advised as excitability may occur, particularly in pediatric patients. Healthcare professionals should instruct caregivers to discontinue use and consult a doctor if pain worsens or persists beyond 5 days in children aged 6 to under 12 years, or if fever worsens or lasts more than 3 days.

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. 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 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 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. 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 more than 5 doses are taken in the same timeframe. Additionally, the concurrent use of other medications containing acetaminophen can further elevate the risk of liver injury. Patients 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 to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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

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 question.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can 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, reports indicate that in cases of accidental overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent. It is recommended to contact a Poison Control Center or seek medical help without delay.

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 be encouraged to consult with a doctor or pharmacist.

It is essential to instruct patients not to use this product if they have a history of allergic reactions to it or any of its ingredients. Additionally, patients should be cautioned against using this product to induce sleepiness in children.

Patients should be advised to discontinue use and consult a doctor if their pain worsens or persists beyond 5 days for children aged 6 to under 12 years, or 10 days for adults. They should also be instructed to seek medical advice if new symptoms arise, if fever worsens or lasts more than 3 days, or if any redness or swelling is observed.

When using this product, patients may experience excitability, particularly in children. They should be made aware that drowsiness may occur and that the use of alcohol, sedatives, or tranquilizers can enhance this effect. Caution should be advised when driving or operating machinery.

Patients should be instructed to avoid alcoholic beverages while using this product. Furthermore, they should be encouraged to consult a doctor before use if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or any breathing problems such as emphysema or chronic bronchitis. It is also advisable for patients to seek guidance from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in tamper-evident packaging. 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.

Storage conditions require the product to be maintained at a temperature of 25ºC (77ºF). However, excursions are permitted within a range of 15ºC to 30ºC (59ºF to 86ºF). Proper handling and storage 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.

View product document (PDF)