Coricidin Hbp Maximum Strength Nighttime Cold and Flu

Description

Coricidin® HBP Cold Relief for People with High Blood Pressure is a maximum strength nighttime formulation designed to alleviate symptoms associated with cold and flu. This product provides relief from body aches and pains, headaches, fever, cough, sore throat, runny nose, and sneezing. It is formulated to be sugar-free, alcohol-free, and decongestant-free. The active ingredients include acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, which acts as a cough suppressant; and doxylamine succinate, an antihistamine. The product is available in a liquid dosage form, with a total volume of 12 fluid ounces (355 mL).

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 30 mL using the dosing cup provided every 4 hours as needed. The total daily dosage must not exceed 150 mL, which corresponds to a maximum of 5 doses 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 strictly to the recommended dosage and frequency to avoid potential adverse effects.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson's disease. Verify with a healthcare professional if there is uncertainty regarding MAOI content in prescribed medications.

• Individuals with a history of allergic reactions to this product or any of its ingredients should not use it.

• This product is not recommended for use in children under 12 years of age.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical guidance if they have any of the following conditions: liver disease, glaucoma, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), difficulty urinating due to prostate gland enlargement, breathing problems (such as emphysema or chronic bronchitis), cough accompanied by excessive phlegm, or if they are on a sodium-restricted diet. Additionally, patients should consult a doctor or pharmacist before use if they are taking the blood-thinning medication warfarin or if they are using sedatives or 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 right away, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a healthcare provider if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use 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 or allergic reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants in clinical settings have reported excitability, particularly in children, as well as marked drowsiness. Caution is advised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients are advised to stop use and consult a doctor if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs with a rash or headache lasting longer than expected, as these may indicate a serious condition.

Additional precautions include avoiding the use of this product with any other drug containing acetaminophen, and it should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or for 2 weeks following the cessation of an MAOI. Patients with a history of allergic reactions to this product or its ingredients should also refrain from use.

This product is not recommended for children under 12 years of age. Patients should consult a doctor prior to use if they have liver disease, glaucoma, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), difficulty urinating due to prostate enlargement, breathing problems like emphysema or chronic bronchitis, cough with excessive phlegm, or are on a sodium-restricted diet. Additionally, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a healthcare professional before use. Pregnant or breastfeeding individuals are also encouraged to consult a health professional prior to use.

Drug Interactions

Concurrent use of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

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 two weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for individuals using sedatives or tranquilizers, as the combination may enhance sedative effects. The concurrent consumption of alcohol, sedatives, and tranquilizers can lead to increased drowsiness, necessitating careful monitoring of patients for excessive sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Coricidin Hbp Maximum Strength Nighttime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). 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. When administered, excitability may occur, particularly in pediatric populations, and marked drowsiness has been observed in children. It is essential to keep this product 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. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 no specific data available 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 to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, as this may necessitate careful monitoring and potential dosing adjustments.

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 concurrent use with other medications that contain 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 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, it is essential to monitor the patient closely and provide comprehensive care as needed.

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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No specific adverse reactions or safety updates related to postmarketing experience have been reported in the available data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help 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 present.

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 consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Patients should be encouraged to ask their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, this product is not recommended for children under 12 years of age.

While using this product, patients may experience excitability, particularly in children, and should be made aware that marked drowsiness may occur. They should be cautioned to avoid alcoholic beverages while using this product, as alcohol, sedatives, and tranquilizers can enhance drowsiness.

Patients should be advised to exercise caution when driving or operating machinery while using this product. It is also essential to recommend that patients consult a doctor before use if they have any of the following conditions: liver disease, glaucoma, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), difficulty urinating due to prostate gland enlargement, breathing problems like emphysema or chronic bronchitis, cough with excessive phlegm, or if they are on a sodium-restricted diet.

Finally, patients should be encouraged to speak with their healthcare provider or pharmacist before using this product if they are 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 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)