Cold and Flu Hbp

Description

No description information is available for the specified drug.

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 advised on 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, 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.

• In individuals with a history of allergic reactions to this product or any of its components, as this may lead to severe allergic responses.

• For the purpose of inducing sleepiness in children, as this use is not appropriate and may pose safety concerns.

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. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant in assessing patients for severe sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Prior to recommending this product, healthcare professionals should inquire about any existing medical conditions. Patients with difficulty urinating due to prostate gland enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis should consult a doctor before use. Furthermore, patients taking sedatives, tranquilizers, or the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before using this product.

In cases of accidental overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be instructed to discontinue use and consult a physician 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 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. Additionally, the risk of liver damage increases if the product is taken in conjunction with other medications containing acetaminophen or if the patient 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 warning is also applicable; if a patient experiences a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised against using this product if they have a history of allergic reactions to acetaminophen or any of its ingredients, if they are taking any other drug containing acetaminophen, or if the intent is to induce sleepiness in a child.

Before using this product, patients should consult a doctor if they have difficulty urinating due to prostate enlargement, liver disease, glaucoma, or respiratory issues such as emphysema or chronic bronchitis. Additionally, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should seek advice from a healthcare professional prior to use.

While using this product, patients may experience excitability, particularly in children, as well as drowsiness. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages and exercise caution when driving or operating machinery.

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, if new symptoms arise, if fever worsens or lasts more than three days, or if redness or swelling occurs.

In cases of accidental overdose, it is critical for patients 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

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 under 6 years of age should not use this product unless directed by a healthcare professional. For children aged 6 to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 5 tablets in a 24-hour period. In contrast, adults and children 12 years and older may take 2 tablets every 4 to 6 hours, not exceeding 12 tablets in 24 hours.

Caution is advised due to the potential for severe liver damage in children who exceed 5 doses within 24 hours. Additionally, excitability may occur, particularly in pediatric patients, and drowsiness is also a possible side effect.

Healthcare professionals should instruct caregivers to discontinue use and consult a doctor if pain worsens or persists for more than 5 days in children aged 6 to under 12 years, or if new symptoms arise. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center contacted, as prompt intervention is crucial for children, even in the absence of symptoms.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Individualized assessment and clinical judgment are essential when determining the appropriateness of treatment in elderly patients.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 damage increases significantly if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period, if 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 3 or more alcoholic drinks daily while using this product are at an elevated risk for liver damage.

It is recommended 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 during treatment.

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

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 as a potential effect. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to these effects.

No information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no data provided on animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include blisters, rash, and skin reddening. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed that excitability may occur, particularly in children, and that drowsiness is a possible side effect. It is important to discuss the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers, and to strongly recommend that patients avoid alcoholic beverages while using this medication.

Additionally, healthcare providers should counsel patients to exercise caution when driving a motor vehicle or operating machinery, as drowsiness may impair their ability to perform these tasks safely.

Storage and Handling

The product is supplied in tamper-evident packaging. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). Healthcare professionals are advised to check the end flap of the packaging 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 health 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)