Medique Medicidin D, Otis Clapp Valihist

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headache, as well as for the alleviation of nasal congestion, sinus congestion and pressure, runny nose, and sneezing. It also temporarily reduces fever and provides relief from symptoms associated with hay fever, such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. Additionally, this drug temporarily aids in clearing nasal and/or sinus passages.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and not exceed the directed amount.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets taken every 4 to 6 hours as needed. Patients should not exceed a total of 10 tablets within a 24-hour period.

For children under 12 years of age, it is essential to consult a physician for appropriate dosing recommendations.

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

• Use for more than 10 days for pain management unless specifically directed by a healthcare provider, to avoid potential complications associated with prolonged use.

• History of allergic reactions to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, due to the risk of serious drug interactions. If there is uncertainty regarding the presence of an MAOI in current medications, a healthcare professional should be consulted.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the following guidelines to minimize the risk of liver injury:

• Do not exceed 4,000 mg of acetaminophen within a 24-hour period, as this is the maximum recommended daily dosage.

• Avoid concurrent use with other medications that contain acetaminophen.

• Limit alcohol consumption to fewer than three drinks per day while using this product, as increased alcohol intake can exacerbate the risk of liver damage.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of suspected overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur:

• Nervousness, dizziness, or sleeplessness

• Worsening pain or nasal congestion lasting more than 7 days

• Fever that worsens or persists beyond 3 days

• Presence of redness or swelling

• Emergence of new symptoms

Regular monitoring and patient education regarding these warnings and precautions are essential to ensure safe use of this product.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in a 24-hour period, use other medications containing acetaminophen concurrently, or consume 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 skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain or nasal congestion worsens or persists beyond seven days; if fever intensifies or lasts more than three days; if redness or swelling occurs; or if new symptoms develop.

It is recommended that patients consult a doctor prior to use if they have a history of liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma, chronic bronchitis or emphysema, or difficulty urinating due to prostate gland enlargement. Additionally, patients should seek advice from a healthcare provider or pharmacist if they are currently taking the blood-thinning medication warfarin or are using sedatives or tranquilizers.

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 Medique Medicidin D, Otis Clapp Valihist (acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For dosing, adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours, with a maximum of 10 tablets in a 24-hour period.

Caution is warranted as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this product, particularly if they have a history of liver disease, thyroid disease, diabetes, high blood pressure, heart disease, glaucoma, chronic bronchitis or emphysema, or experience difficulty in urination due to prostate gland enlargement.

Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are concurrently taking anticoagulants such as warfarin, or if they are using sedatives or tranquilizers, as these medications may interact and increase the risk of adverse effects.

When using this product, elderly patients must adhere strictly to the recommended dosage to avoid potential excitability, which may be more pronounced in children. Drowsiness is a common side effect; therefore, caution is advised when driving or operating machinery, especially when combined with alcohol, sedatives, or tranquilizers, which may exacerbate drowsiness.

Elderly patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain or nasal congestion worsens or persists beyond 7 days, if fever intensifies or lasts more than 3 days, if there is any redness or swelling, or if new symptoms arise.

In the event of an overdose, it is crucial for elderly patients to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is essential regardless of the presence of symptoms.

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 to ensure the safety of both the mother and the fetus or infant.

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 available data 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 information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosage guidelines is essential for patients with hepatic impairment to minimize the risk of adverse effects.

Overdosage

In cases of acetaminophen overdosage, significant health risks are associated with excessive intake.

Risk of Severe Liver Damage Administration of more than 4,000 mg of acetaminophen within a 24-hour period can result in severe liver damage. Healthcare professionals should be vigilant in assessing the total daily dosage of acetaminophen, especially in patients who may be using multiple products containing this active ingredient.

Coadministration with Other Acetaminophen-Containing Products The risk of overdose is notably increased when acetaminophen is taken concurrently with other medications that also contain acetaminophen. It is crucial for healthcare providers to review all medications a patient is taking to prevent unintentional overdose.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using acetaminophen are at an elevated risk for severe liver damage. Healthcare professionals should counsel patients on the dangers of combining alcohol with acetaminophen and consider alternative pain management strategies for those with a history of alcohol use.

Management Procedures In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management protocols, which may include the administration of N-acetylcysteine as an antidote, and monitor liver function tests to assess the extent of liver injury. Prompt recognition and intervention are critical to mitigate the potential consequences of acetaminophen overdosage.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 product out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients who are pregnant or breastfeeding should be encouraged to consult a health professional before using this product to ensure safety for themselves and their child.

When using this product, patients must be instructed 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. It is important to inform patients that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and therefore, they should avoid alcoholic beverages while using this product. Additionally, patients should exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to store the packets at room temperature, specifically within the range of 59º-86ºF (15º-30ºC). Care should be taken to avoid exposure to excessive heat and humidity, as these conditions may compromise the product's quality.

Opened or torn packets must not be used, as they may not provide the necessary protection against contamination. Proper handling and storage are crucial to maintaining the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Medique Medicidin D, Otis Clapp Valihist, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)