Pentrexcilina Daytime

Description

COLD & FLU is a combination medication formulated for daytime relief from cold and flu symptoms. Each tablet contains 500 mg of Acetaminophen, 4 mg of Chlorpheniramine Maleate, and 10 mg of Phenylephrine HCl. The product is identified by NDC 69729-223-38 and is packaged in a total of 144 tablets, distributed in 72 pouches containing 2 tablets each. This formulation is designed to alleviate symptoms such as headache, nasal congestion, itchy and watery eyes, as well as runny nose and sneezing.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with hay fever or other respiratory allergies. These symptoms include headache, sinus congestion and pressure, nasal congestion, runny nose, sneezing, minor aches and pains, as well as additional symptoms such as nose or throat itching and itchy, watery eyes.

This drug also aids in clearing nasal passages and decongesting sinus openings and passages.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet taken with water every 4 to 6 hours as needed. It is imperative that patients do not exceed 6 tablets within a 24-hour period. Tablets must be swallowed whole; they should not be crushed, chewed, or dissolved to maintain the integrity of the formulation.

For children aged 4 to 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The use of this medication is not recommended for children under 4 years of age.

Healthcare professionals should remind patients of the importance of not exceeding the directed dosage and to be aware of the overdose warning associated with this medication.

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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek guidance from a healthcare professional.

• In individuals with a known history of allergic reactions to this product or any of its components.

• For the purpose of inducing sleepiness in children, as this use is not indicated.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals should be aware of to ensure safe use.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 6 tablets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare provider promptly.

General Precautions Prior to use, patients should be advised to consult a healthcare professional if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, trouble urinating due to an enlarged prostate gland, or a breathing problem such as emphysema or chronic bronchitis. Furthermore, it is essential to seek guidance from a doctor or pharmacist if the patient is currently taking blood-thinning medications such as warfarin or sedatives/tranquilizers.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Discontinuation of Use Patients should stop taking this product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; or if new symptoms develop. These may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 tablets within 24 hours, use it concurrently with other drugs containing acetaminophen, or consume 3 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 skin reddening, blisters, or rash. 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Common adverse reactions may include excitability, particularly in children, and drowsiness. The use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery due to the potential for drowsiness.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling is present; or if new symptoms arise, as these may indicate a serious condition.

This product should not be used in conjunction with any other drug containing acetaminophen, by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication, or by those with a known allergy to this product or any of its ingredients. It is also contraindicated for use in children to induce sleep.

Patients are advised to consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, difficulty urinating due to an enlarged prostate gland, or a breathing problem such as emphysema or chronic bronchitis. Furthermore, patients should seek guidance from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

An overdose of this product can lead to serious health complications. In the event of an 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 if no signs or symptoms are initially apparent.

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.

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, and for a period of 2 weeks following the discontinuation of an MAOI. This interaction may lead to serious and potentially life-threatening side effects.

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

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation and potential respiratory depression is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Pentrexcilina Daytime (acetaminophen, chlorpheniramine maleate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to 12 years should consult a healthcare professional before use. The safety and efficacy of this medication in children under 4 years of age have not been established; therefore, it is contraindicated in this age group.

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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in 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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is important for these patients to be monitored closely for any adverse effects. If symptoms such as nervousness, dizziness, or sleeplessness occur, or if pain or nasal congestion worsens or persists beyond 7 days, patients should discontinue use and seek medical advice. Additionally, if fever intensifies or lasts more than 3 days, or if there is any redness or swelling, patients are advised to contact their healthcare provider. New or unexpected symptoms should also prompt a consultation with a healthcare professional. Pregnant or breastfeeding patients should seek guidance from a health professional before use.

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 maximum recommended dosage is 6 tablets within a 24-hour period. Exceeding this dosage, using other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

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. Regular 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 overdose, it is imperative to recognize that exceeding the recommended dosage can lead to serious health complications. Healthcare professionals should advise patients and caregivers 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 noticeable signs or symptoms. It is essential to monitor the patient closely and provide appropriate care based on the clinical presentation and the specific substance involved in the overdose.

Healthcare providers should ensure that patients are aware of the risks associated with overdosing and the importance of adhering to prescribed dosages to prevent adverse health outcomes.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. 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 keep this medication out of reach of children to prevent accidental ingestion. They should emphasize the importance of adhering to the recommended dosage, as taking more than directed can lead to serious health problems. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical 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 whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to ask their healthcare provider if they are unsure whether their prescription includes an MAOI.

It is crucial to inform patients not to use this product if they have a history of allergic reactions to it or any of its ingredients. Patients should also be cautioned against using this medication to induce sleepiness in children.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to seek medical attention if pain or nasal congestion worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that drowsiness is a possible side effect. Patients should be cautioned that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and they should avoid alcoholic beverages while taking this medication. Additionally, patients should exercise caution when driving or operating machinery.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should be advised to consult a doctor before using this product. Furthermore, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should also seek guidance from their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the package or blister unit is open or shows any signs of tampering.

Storage conditions require the product to be maintained at room temperature, specifically between 20-25°C (68-77°F). Temporary excursions are permissible within the range of 15°C-30°C (59°F-86°F). It is essential to avoid exposure to excessive heat and humidity to ensure the integrity of the product.

Additional Clinical Information

Patients should swallow the tablets whole and not crush, chew, or dissolve them. The recommended dosage for adults and children aged 12 years and older is 1 tablet with water every 4-6 hours as needed, with a maximum of 6 tablets in a 24-hour period. For children aged 4 to 12 years, it is advised to consult a doctor before use, while the product is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek medical advice prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, trouble urinating due to an enlarged prostate gland, or a breathing problem such as emphysema or chronic bronchitis. Additionally, patients taking the blood-thinning medication warfarin or sedatives/tranquilizers should consult a doctor or pharmacist before use. Pregnant or breastfeeding patients are also advised to seek guidance from a health professional prior to use.

Drug Information (PDF)

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

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