Coricidin Hbp

Description

Coricidin® HBP is a decongestant-free formulation designed for cold symptom relief in individuals with high blood pressure. Each tablet contains chlorpheniramine, an antihistamine, and acetaminophen, a pain reliever and fever reducer. This combination effectively alleviates symptoms such as runny nose, sneezing, body aches and pains, and fever. The product is supplied in a package containing 10 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headache, sneezing, and runny nose. It also temporarily reduces fever. Additionally, this drug provides cold symptom relief for individuals with high blood pressure.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is 2 tablets administered 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 exceeding 5 tablets in a 24-hour period.

For children under 6 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Healthcare professionals should ensure that patients are informed about the importance of adhering to the specified dosage limits to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or non-prescription. This is due to the risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Adults should not exceed 12 tablets within a 24-hour period, while children should not take more than 5 tablets in the same timeframe. The risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

General precautions must be observed to ensure safe use. It is imperative to avoid the concurrent use of any other drug containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional, such as a doctor or pharmacist, is advised.

Prior to use, individuals should seek medical advice if they have any of the following conditions: liver disease, respiratory issues such as emphysema or chronic bronchitis, glaucoma, or difficulty urinating due to an enlarged prostate gland. Additionally, it is important to consult a healthcare professional if the user is taking blood thinners like warfarin or is on sedatives or tranquilizers.

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

Users should discontinue use and consult a doctor if any of the following occur: pain worsens or persists beyond 5 days for children aged 6 to under 12 years or 10 days for adults; fever worsens or lasts more than 3 days; redness or swelling is observed; or new symptoms develop.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage of 12 tablets in 24 hours for adults or 5 tablets for children. Additionally, the risk of liver damage increases if the product is taken concurrently with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product. In cases of overdose, it is critical for patients to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Common adverse reactions reported during the use of this product include excitability, particularly in children, and drowsiness. Patients are advised to avoid alcoholic beverages, as the combination of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for impaired alertness.

Patients should discontinue use and consult a healthcare professional if pain worsens or persists beyond 5 days for children aged 6 to under 12 years or 10 days for adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise.

Before using this product, patients should seek medical advice if they have liver disease, breathing problems such as emphysema or chronic bronchitis, glaucoma, or difficulty urinating due to an enlarged prostate gland. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring due to potential alterations in anticoagulant effects.

Additionally, the concurrent use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is advised when engaging in activities that require alertness, and dosage adjustments may be necessary to mitigate the risk of excessive sedation. Monitoring for increased sedation and impairment is recommended in patients using these substances together.

Packaging & NDC

Below are the non-prescription pack sizes of Coricidin Hbp (acetaminophen and 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 of age, it is advised to consult a doctor before use.

Healthcare professionals should be aware of a liver warning indicating that exceeding 5 tablets in 24 hours may pose risks. Additionally, excitability may occur during treatment, particularly in children.

If pain worsens or persists beyond 5 days in children aged 6 to under 12 years, it is recommended to discontinue use and consult a doctor. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is crucial for both adults and children.

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. 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 consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The product contains acetaminophen, which poses a risk of severe liver damage. Adults should not exceed 12 tablets within a 24-hour period, and children should not take more than 5 tablets in the same timeframe. Additionally, the risk of liver damage increases if the product is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Patients are advised to adhere strictly to the recommended dosage, as exceeding this may lead to liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Exceeding the recommended dosage of this medication may result in significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the onset of symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of proactive management even in the absence of observable signs or symptoms.

Timely medical attention can be critical in mitigating the effects of an overdose and ensuring patient safety.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and drowsiness has been reported. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Reports from postmarketing surveillance have indicated instances of excitability, particularly in pediatric populations, as well as drowsiness associated with the use of this product. These events were reported voluntarily and through various surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication 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 non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be informed to discontinue use and seek medical advice if they experience any of the following: worsening pain that lasts more than 5 days for children aged 6 to under 12 years or more than 10 days for adults; a fever that worsens or persists for more than 3 days; the presence of redness or swelling; or the emergence of new symptoms.

While using this product, patients should be made aware that excitability may occur, particularly in children, and that drowsiness is a possible side effect. They should be cautioned to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness. Patients should also be advised to exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have any of the following conditions: liver disease; a breathing problem such as emphysema or chronic bronchitis; glaucoma; or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be encouraged to speak with a doctor or pharmacist before use if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper handling procedures should be followed to ensure the product remains within the specified temperature range throughout its storage and usage.

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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)