Cold Medicine

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "34089" on one side and "3" on the opposite side, containing 3 mg of the active ingredient. The formulation includes several inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headaches. It also provides temporary relief from nasal congestion, sinus congestion and pressure, runny nose, and sneezing.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 2 tablets orally every 4 hours, with a maximum dosage not to exceed 12 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is contraindicated, as it may result in an overdose and potential liver damage.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to acetaminophen should not use this product due to the risk of severe allergic reactions. The product should not be used for more than 10 days unless directed by a healthcare professional, as prolonged use may lead to adverse effects. Concurrent use with monoamine oxidase inhibitors (MAOIs) is contraindicated, as it may lead to significant drug interactions; this includes use during treatment and for 2 weeks following the cessation of MAOI therapy. Additionally, the product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, to avoid the risk of acetaminophen overdose.

Patients are also advised to avoid alcoholic beverages while using this product, as alcohol can exacerbate the risk of liver damage associated with acetaminophen.

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 recommended dosage, as taking more than 12 tablets within a 24-hour period constitutes the maximum daily amount. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as this can increase the risk of liver injury. Additionally, patients should be informed that consuming three or more alcoholic drinks daily while using this product may further elevate the risk of liver damage.

Acetaminophen has been associated with severe skin reactions, which may manifest as 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 at 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.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience any of the following: redness or swelling, the emergence of new symptoms, feelings of nervousness, dizziness, or sleeplessness, worsening pain or nasal congestion lasting more than seven days, or a fever that worsens or persists for more than three days. Monitoring for these symptoms is essential to ensure patient safety and effective management of any adverse effects.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 12 tablets within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, 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.

Patients are advised to stop use and consult a healthcare professional if they experience redness or swelling, new symptoms arise, or if they feel nervous, dizzy, or sleepless. Additionally, if pain or nasal congestion worsens or persists for more than seven days, or if fever intensifies or lasts longer than three days, medical advice should be sought.

Prior to using this product, patients with pre-existing conditions such as liver disease, heart disease, glaucoma, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider. Furthermore, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should also seek guidance from a doctor or pharmacist before use.

Drug Interactions

The concomitant use of monoamine oxidase inhibitors (MAOIs) with this medication is contraindicated. Patients should not use this medication while taking MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating therapy if they are currently taking warfarin.

Additionally, the use of alcohol, sedatives, and tranquilizers in combination with this medication may potentiate drowsiness. Patients should be monitored for increased sedation and advised to avoid such substances to mitigate the risk of excessive drowsiness.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Medicine (acetaminophen chlorpheniramine maleate phenylepherine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication, as it may result in an overdose that could lead to liver damage. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, with a maximum of 12 tablets in a 24-hour period.

Healthcare professionals should be aware that excitability may occur, particularly in children. Caution is advised when prescribing this medication to pediatric populations.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 12 tablets within a 24-hour period. Additionally, patients must avoid concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than three alcoholic drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with pre-existing liver conditions to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product, particularly concerning liver function.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 12 tablets within a 24-hour period, which is the established maximum daily dosage. Additionally, the risk of liver damage is heightened when this product is taken concurrently with other medications that contain acetaminophen.

Furthermore, patients who consume three or more alcoholic beverages daily while using this product are also at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should monitor liver function and consider appropriate interventions based on the severity of the symptoms presented. Early recognition and management are crucial to mitigate the potential for serious hepatic injury.

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 the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important for patients to understand the potential risks and benefits associated with its use during these periods.

Providers should emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion. Patients should be informed about the importance of safeguarding medications to ensure child safety.

In the event of an overdose, healthcare providers must instruct patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. It is crucial to convey that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Storage and Handling

The product is supplied in blister packages. Each blister package must be inspected prior to use; do not use if the blister package is torn.

For optimal storage, the product should be kept at room temperature in a dry place to maintain its integrity and effectiveness.

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 overdose, patients should seek medical assistance or contact a Poison Control Center (1-800-222-1222) 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 Medicine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)