Severe Cold and Cough Relief

Description

This formulation contains acetaminophen (650 mg), a pain reliever and fever reducer; dextromethorphan HBr (20 mg), a cough suppressant; and phenylephrine HCl (10 mg), a nasal decongestant. The product also includes 10% alcohol and is flavored with berry. It is manufactured by PL Developments, located at 11865 S. Alameda St, Lynwood, CA 90262. The product features a tamper-evident safety seal, which should not be used if broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including minor aches and pains, headache, nasal and sinus congestion, sore throat, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum allowable dosage is 6 doses, equating to 180 mL, within a 24-hour period.

For administration, the dosing cup provided with the product must be used exclusively for measuring the dose; no other dosing devices should be utilized. It is essential to keep the dosing cup with the product to ensure proper measurement.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours as needed. The use of this product is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose.

Additionally, patients should not exceed the recommended dosage, as this may lead to adverse effects.

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 drinks daily while taking this product.

Acetaminophen may also lead to 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 should be taken prior to use. Patients should be encouraged to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, those with a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, should seek medical advice before use. It is also essential to consult a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin.

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

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, cough, or nasal congestion worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical consultation is warranted. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual may indicate a serious condition, necessitating prompt medical evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are present.

Patients should also be alert to the possibility of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients must discontinue use and seek medical assistance promptly.

In addition, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider immediately.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough returns or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

Before using this product, patients should consult a healthcare provider if they have a history of liver disease, heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

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

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating therapy if they are currently taking warfarin. Monitoring of coagulation parameters may be warranted to ensure patient safety and therapeutic efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Cold and Cough Relief (acetaminohpen, dextromethorphan hbr, 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 30 mL every 4 hours. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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. 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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 4,000 mg of acetaminophen in a 24-hour period, as well as avoid the concurrent use of other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Recommended Actions

Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Healthcare professionals should be vigilant in assessing the situation and providing necessary interventions.

Potential Symptoms

While specific symptoms of overdose are not detailed, the risk of liver damage underscores the importance of monitoring for any signs of hepatic impairment following an overdose.

Management Procedures

Upon recognition of an overdose, healthcare providers should initiate appropriate management protocols, which may include supportive care and monitoring of liver function. Early intervention can significantly impact patient 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 several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage of the medication. Patients must be informed that taking more than the recommended dose can lead to serious health risks, including potential liver damage.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Reinforcing the message to not exceed the recommended dosage is vital to ensure patient safety and prevent adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)