Cold and Flu Hbp

Description

equate™ is a decongestant-free formulation indicated for individuals with high blood pressure. Each tablet contains acetaminophen, a pain reliever and fever reducer, and chlorpheniramine maleate, an antihistamine. The product is designed to relieve symptoms such as runny nose, sneezing, body aches and pains, fever, and sore throat. The package contains 20 tablets and features a tamper-evident warning, stating 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 Walmart Inc., Bentonville, AR 72716. For inquiries, a satisfaction guarantee contact is available at 1-888-287-1915. This product is not manufactured or distributed by Bayer HealthCare LLC, the owner of the registered trademark Coricidin® HBP Cold & Flu.

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 hypersensitivity reactions.

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

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Severe liver injury may occur 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 the same timeframe, if it is used concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic beverages daily while using this product.

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

Healthcare professionals should be vigilant regarding 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 advised.

Before recommending this product, it is essential to inquire whether the patient has 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 advised to consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the anticoagulant warfarin.

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

Patients should 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. They should also seek medical advice if new symptoms arise, if fever worsens or lasts more than 3 days, or if there is any redness or swelling.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than 5 doses in the same timeframe, or if the product is used concurrently with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

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 in place; 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.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than 5 days in children aged 6 to under 12 years, or longer than 10 days in adults. New symptoms, worsening fever lasting more than 3 days, or the presence of redness or swelling should also prompt medical consultation.

While using this product, patients should exercise caution as alcohol, sedatives, and tranquilizers may enhance drowsiness. Drowsiness and excitability, particularly in children, may occur, and patients are advised to avoid operating motor vehicles or machinery while under the influence of the medication.

Patients with certain medical conditions should seek medical advice before using this product, including those with difficulty urinating due to prostate enlargement, liver disease, glaucoma, or breathing problems such as emphysema or chronic bronchitis. Furthermore, individuals taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

In cases of accidental overdose, it is crucial 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

The concomitant use of this product with warfarin, an anticoagulant, may lead to an increased risk of bleeding. It is advisable to monitor the patient's INR (International Normalized Ratio) closely and consider dosage adjustments of warfarin as necessary to maintain therapeutic levels.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this product may potentiate drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery.

No specific interactions with laboratory tests have been 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 take 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 excitability may occur, particularly in pediatric patients. If pain worsens or persists for more than 5 days in children aged 6 to under 12 years, it is advised to discontinue use and consult a doctor.

In the event of an accidental overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is essential. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions associated with the use of this medication. 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 general variability in drug metabolism and sensitivity in this population. Individualized assessment and clinical judgment are essential when determining the appropriateness of this medication for elderly patients.

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 caution is advised to ensure the well-being of both the mother and the fetus.

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 medication 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 prudent in these patients 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 important 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, taking more than 5 doses in a 24-hour period poses a similar risk. Additionally, the concurrent use of other medications containing acetaminophen can increase the likelihood of liver injury. Patients who consume 3 or more alcoholic drinks daily while using this product are also at an elevated risk for liver damage.

It is advised 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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions, as reported in postmarketing surveillance. Symptoms of these reactions may include blisters, rash, and skin reddening. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, cases of accidental overdose have been reported. In such instances, it is crucial to obtain medical help or contact a Poison Control Center without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patient Counseling

Healthcare providers should advise patients about 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 seek medical help right away, as prompt medical attention is critical for both adults and children. It is essential to emphasize that even if no signs or symptoms are apparent, medical evaluation is necessary to ensure safety and appropriate care.

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 must 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)