Severe Cold

Description

This formulation contains Acetaminophen, a pain reliever and fever reducer, Dextromethorphan HBr, a cough suppressant, Guaifenesin, an expectorant, and Phenylephrine HCl, a nasal decongestant. The product is alcohol-free and is presented in the form of softgels, which are liquid-filled capsules.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including headache, nasal congestion, sore throat, cough, and minor aches and pains. Additionally, it temporarily reduces fever and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 softgels every 4 hours, with a maximum limit of 12 softgels within a 24-hour period.

It is imperative that patients do not exceed the directed dosage, as an overdose may lead to serious health risks. The use of this medication is not recommended for children under 12 years of age.

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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to using this product.

• Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

General precautions are warranted for patients with specific health conditions. Prior to use, individuals should consult a healthcare provider if they have liver disease, diabetes, high blood pressure, heart disease, thyroid disease, difficulty urinating due to an enlarged prostate, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough with excessive phlegm should seek medical advice. It is also essential for patients taking the anticoagulant warfarin to consult a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, regardless of the presence of symptoms.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical consultation is necessary. Redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by fever, rash, or headache that persists should also prompt immediate medical evaluation, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if patients exceed 4,000 mg of acetaminophen within 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, 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 consult a healthcare professional if they experience severe sore throat that persists for more than two days, especially if accompanied by fever, headache, rash, nausea, or vomiting. Additionally, individuals should stop use and seek medical advice if they encounter nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever intensifies or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs with fever, rash, or headache lasting longer than expected, as these may indicate a serious condition.

Patients with pre-existing conditions such as liver disease, diabetes, high blood pressure, heart disease, thyroid disease, or urinary difficulties due to an enlarged prostate gland should consult a doctor prior to use. Those with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, as well as those experiencing cough with excessive phlegm, should also seek medical advice before using this product. Furthermore, individuals taking the anticoagulant warfarin should consult a healthcare provider or pharmacist before use.

An overdose warning is in place, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) 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 other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI to avoid potential hypertensive crises or other serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could increase the risk of bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Cold (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 softgels every 4 hours.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 no specific data available regarding the excretion of this medication in 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 essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of liver injury:

• Patients should not exceed 4,000 mg of acetaminophen in a 24-hour period.

• Caution is advised when using this product in conjunction with other medications that contain acetaminophen, as this may increase the risk of overdose and subsequent liver damage.

• Consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the risk of liver injury.

Before using this product, patients with liver disease should consult a healthcare professional to assess the appropriateness of treatment.

In the event of an overdose, which may occur if the recommended dose is exceeded, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe liver injury and to ensure appropriate care is provided.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial 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 be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription medication contains an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. New symptoms or a recurrence of cough, especially if accompanied by fever, rash, or a lasting headache, should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the directed dosage. Healthcare providers should encourage patients to seek medical advice before using this product if they have any of the following conditions: liver disease, diabetes, high blood pressure, heart disease, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare professional before use. Furthermore, patients should be advised to speak with a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to inspect the carton before use; do not use if the carton is opened or if the blister unit is torn, broken, or shows any signs of tampering.

For optimal storage, the product should be maintained at a temperature range of 20-25ºC (68-77ºF). It is important to avoid exposure to excessive heat. Healthcare professionals should advise patients to swallow the product whole and not to crush, chew, or dissolve it.

The outer carton should be retained for complete warnings and product information.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels every 4 hours, not to exceed 12 softgels within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use.

Patients should be informed to keep the medication out of reach of children and to be aware of the overdose warning. Taking more than the recommended dose may lead to liver damage, and in the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no symptoms are present.

Drug Information (PDF)

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

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