Cetafen Cough and Cold

Description

No relevant information is available for SPL code 34089-3, and therefore, a detailed description cannot be provided.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including cough, sore throat, headache, minor aches and pains, and nasal congestion. Additionally, it aids in loosening phlegm (mucus) and bronchial secretions, thereby making coughs more productive. This drug also temporarily reduces fever.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 2 tablets orally every 6 to 8 hours as needed while symptoms persist. It is imperative that they do not exceed a total of 8 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other product containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose.

Additionally, the product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease. Use is also prohibited for 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAO in a prescription drug, the product should not be used.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of liver damage if not used according to the guidelines. Healthcare professionals should advise patients that severe liver injury may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while taking this product.

Patients should also be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of an allergic reaction may include skin reddening, blisters, or rash. In such cases, immediate medical attention is warranted.

In instances of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider promptly.

Patients are advised to discontinue use and seek medical advice if any of the following occur:

• Signs of an allergic reaction, which necessitate immediate medical assistance.

• The emergence of new symptoms.

• Experiences of nervousness, dizziness, or insomnia.

• Worsening pain, nasal congestion, or cough lasting longer than seven days.

• Presence of redness or swelling.

• Fever that worsens or persists beyond three days.

• Recurrence of cough, especially if accompanied by rash or a headache that lasts.

Healthcare professionals should remain vigilant and ensure that patients are aware of these warnings and precautions to promote safe use of the product.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may lead to liver damage, prompt medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent. Patients are advised to seek medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

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 an allergic reaction, immediate medical assistance is necessary. Patients are also advised to discontinue use and consult a healthcare professional if new symptoms arise, if they experience nervousness, dizziness, or sleeplessness, or if pain, nasal congestion, or cough worsens or persists beyond seven days. Additionally, if redness or swelling occurs, or if fever worsens or lasts more than three days, medical advice should be sought. Patients should also be vigilant for a returning cough, particularly if it is accompanied by a rash or headache lasting longer than usual.

Before using this product, patients with a history of heart, liver, or thyroid disease, high blood pressure, diabetes, glaucoma, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider. Those with respiratory issues, such as chronic bronchitis, emphysema, or a cough with excessive phlegm, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin or those uncertain if their other medications contain acetaminophen should consult a doctor or pharmacist before use.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or non-prescription, 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), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. Patients should be advised to confirm whether their prescription medications contain an MAOI to avoid serious interactions.

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 use to assess the need for dosage adjustments or increased monitoring of coagulation parameters.

Packaging & NDC

Below are the non-prescription pack sizes of Cetafen Cough and Cold (cold medicine). 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 adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 to 8 hours as needed for symptom relief, with a maximum of 8 tablets in a 24-hour period unless otherwise directed by a physician.

Geriatric Use

Elderly patients may not have specific geriatric use information available for this medication. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions pertinent to this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and overall health status. Regular monitoring may be advisable to ensure safety and efficacy in this demographic.

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 of these patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Due to the potential for severe liver damage, it is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

Additionally, patients with compromised liver function must be aware that taking this product in conjunction with other medications containing acetaminophen can significantly increase the risk of severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily should avoid using this product, as this combination may also lead to severe liver damage. Regular monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and prevent adverse effects.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals recognize the urgency of the situation, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

In the event of an overdose, immediate action is required. Healthcare providers should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222, where trained professionals can provide guidance on the necessary steps to take following an overdose.

Monitoring for symptoms of liver damage is essential, and healthcare professionals should be prepared to manage potential complications associated with overdose. Early intervention can significantly improve outcomes, underscoring the importance of swift action in these scenarios.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription, to avoid the risk of overdose.

It is crucial to discuss the contraindications associated with monoamine oxidase inhibitors (MAOIs). Patients should be cautioned against using this medication if they are currently taking a prescription MAOI or have stopped taking one within the last two weeks. If patients are uncertain whether their prescription includes an MAO, they should be encouraged to consult their healthcare provider.

Patients should be instructed to stop using the medication and seek medical attention immediately if they experience any signs of an allergic reaction. Additionally, they should be advised to discontinue use and consult a doctor if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness.

Healthcare providers should emphasize the importance of monitoring symptoms. Patients should be advised to stop use and contact a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days. They should also be informed to seek medical advice if they notice any redness or swelling, if fever worsens or lasts longer than three days, or if a cough returns or occurs alongside a rash or persistent headache.

Before initiating treatment, patients should be encouraged to consult their healthcare provider if they have any pre-existing conditions, including heart, liver, or thyroid disease, high blood pressure, diabetes, glaucoma, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients with breathing problems or a cough that produces excessive phlegm, or those with chronic conditions such as smoking-related cough, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Lastly, patients taking the blood-thinning medication warfarin should be advised to consult their doctor or pharmacist before using this product. They should also be encouraged to seek guidance if they are unsure whether any other medications they are taking contain acetaminophen.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets every 6 to 8 hours while symptoms persist, with a maximum of 8 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important 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 immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)