Cold and Flu Hbp

Description

This product contains Acetaminophen 325 mg, a pain reliever and fever reducer, and Chlorpheniramine Maleate 2 mg, an antihistamine. It is indicated for the relief of symptoms associated with runny nose, sneezing, body aches and pains, fever, and sore throat. The formulation is specifically designed for individuals with high blood pressure. Each package contains 20 tablets. The product is tamper evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. It is distributed by Winco Foods, LLC, located in Boise, ID 83704.

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, 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.

Healthcare professionals should ensure that patients are aware of the importance of adhering 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 another medication, consultation with a healthcare professional is advised.

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

• This product should not be used for the purpose of inducing sleepiness in children.

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 if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should advise patients to consult a doctor prior to use 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 be cautioned to seek advice 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 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 a 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 adverse reactions associated with this product include significant liver damage, which may occur if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, if a child takes more than five doses in 24 hours, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions, 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. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Individuals with a history of allergic reactions to this product or any of its ingredients should also refrain from use. It is contraindicated for use in children to induce sleepiness.

Patients are advised to consult a doctor before using this product if they have difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek guidance from a healthcare professional prior to use.

While using this product, drowsiness may occur, and the effects may be exacerbated by alcohol, sedatives, or tranquilizers. Caution is advised when driving or operating machinery. Excitability may also be observed, particularly in children, and the consumption of alcoholic beverages should be avoided.

Patients should discontinue 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. New symptoms, worsening fever lasting more than three days, or the presence of redness or swelling should also prompt medical consultation.

In cases 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

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.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers. The combination may enhance the sedative effects, leading to increased drowsiness and potential impairment of cognitive and motor functions.

Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider before using this medication. There may be an increased risk of bleeding due to potential interactions that could affect warfarin's anticoagulant effect.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness. Monitoring for excessive sedation and impairment is advised in patients using these combinations.

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.

Healthcare professionals should be aware that drowsiness may occur in pediatric patients, and excitability is particularly noted in children. It is important to monitor for worsening pain or fever; if pain persists for more than 5 days or fever lasts more than 3 days, a physician should be consulted.

Additionally, caution is advised regarding liver health, as severe liver damage may occur if a child exceeds 5 doses within a 24-hour timeframe.

Geriatric Use

Elderly patients may not require specific dosage adjustments or present unique safety concerns based on the available data. However, it is essential for healthcare providers to consider general precautions when prescribing to this population.

Patients aged 65 and older should be advised to consult a physician prior to use if they have a history of liver disease, as this condition may lead to diminished liver function, which could affect drug metabolism and clearance.

Additionally, drowsiness is a potential side effect of the medication, and caution is warranted when engaging in activities that require alertness, such as driving or operating machinery. This is particularly important for geriatric patients, who may exhibit increased sensitivity to sedative effects.

Furthermore, the concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, necessitating careful consideration of polypharmacy in elderly patients who are often prescribed multiple medications. Monitoring for these interactions and their effects is advised to ensure patient safety.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 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 using this medication, 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 risk of liver injury increases significantly if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, or if a child takes more than 5 doses in the same timeframe. Additionally, the concurrent use of other medications containing acetaminophen can further elevate the risk of hepatotoxicity.

It is also important for patients with compromised liver function to be aware that the consumption of 3 or more alcoholic drinks daily while using this product may exacerbate the potential for liver damage.

Patients with a history of liver disease should consult a healthcare professional prior to using this product to ensure safe usage and to discuss any necessary dosage adjustments or monitoring requirements.

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, it is essential to monitor the patient closely and provide supportive care as necessary.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs, as well as specific interventions based on the substance involved. It is recommended that healthcare providers follow established protocols for overdose management and consult relevant guidelines to ensure comprehensive care.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include blisters, rash, and skin reddening. These events have been reported voluntarily or through surveillance programs.

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 should not be used if the outer package is opened or if the blister is torn or broken. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

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 in the absence of noticeable signs or symptoms.

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)