Signature Care Nighttime Severe Cold and Flu Relief

Description

Signature care® is a maximum strength formulation designed for nighttime severe cold and flu relief. Each 12 FL OZ (355 mL) dose contains 650 mg of acetaminophen, serving as a pain reliever and fever reducer. The formulation also includes 20 mg of dextromethorphan HBr, which acts as a cough suppressant, and 12.5 mg of doxylamine succinate, an antihistamine. Additionally, it contains 10 mg of phenylephrine HCl, a nasal decongestant. The product is available in a berry flavor and is guaranteed for quality. This formulation is comparable to the active ingredients found in Vicks® NyQuil® Severe Cold & Flu.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it addresses the following symptoms: sinus congestion and pressure, nasal congestion, minor aches and pains, headache, runny nose and sneezing, sore throat, cough to aid sleep, and fever. Additionally, it alleviates cough resulting from minor throat and bronchial irritation, reduces swelling of nasal passages, promotes nasal and/or sinus drainage, and temporarily restores freer breathing through the nose.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, with a maximum of 4 doses within a 24-hour period. For children aged 4 to under 12 years, it is advised to consult a healthcare professional for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should emphasize the importance of not exceeding the maximum dosage to avoid potential overdose, as detailed in the accompanying warnings.

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 used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

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

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning 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 instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a cough associated with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate, persistent or chronic cough (e.g., due to smoking, asthma, or emphysema), or if they are on a sodium-restricted diet. Additionally, patients should be cautioned to seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Emergency Medical Help 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) without delay, regardless of whether symptoms are present.

Monitoring and Follow-Up Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or insomnia; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs with a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who 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 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.

If a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer 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 recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Prior to using this product, patients should consult a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or breathing problems such as emphysema or chronic bronchitis. Additionally, those with trouble urinating due to an enlarged prostate gland, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or those on a sodium-restricted diet should seek medical advice.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should also consult a doctor or pharmacist before use.

While using this product, patients should adhere strictly to the recommended dosage, as excitability may occur, particularly in children. Marked drowsiness may also be experienced, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

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

Drug Interactions

Co-administration of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

Caution is advised when considering the use of this medication in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric disorders, or Parkinson’s disease. Patients should seek guidance from a healthcare provider if they are currently taking an MAOI or have discontinued such treatment within the past two weeks.

The concomitant use of this medication with warfarin, an anticoagulant, may elevate the risk of bleeding. Monitoring of coagulation parameters is recommended to ensure patient safety.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may potentiate drowsiness. Patients should be advised to exercise caution and consider avoiding these substances to mitigate the risk of excessive sedation.

Packaging & NDC

Below are the non-prescription pack sizes of Signature Care Nighttime Severe Cold and Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The medication is not recommended for children under 4 years of age.

Caution is advised as excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is essential. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

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 efficacy, 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 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 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 consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

Overdosage

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. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been associated with acetaminophen use. In cases of skin reactions, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness is another reported effect, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers.

Reports indicate that if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days, medical evaluation should be sought. The presence of redness or swelling, the emergence of new symptoms, or the recurrence of cough accompanied by rash or headache that persists may indicate a serious underlying condition requiring further investigation.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing the importance of prompt attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage, as taking more than directed can lead to serious health risks. It is important to inform patients that excitability may occur, particularly in children, and that they should be aware of the potential for marked drowsiness.

Providers should counsel patients to avoid consuming alcoholic beverages while using this medication, as alcohol can exacerbate drowsiness. Additionally, patients should be cautioned about the risks associated with driving a motor vehicle or operating machinery while under the influence of this medication.

Finally, healthcare providers should inform patients that the use of alcohol, sedatives, and tranquilizers in conjunction with this medication may further increase drowsiness, and they should exercise caution in such situations.

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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of 30 mL every 4 hours for adults and children aged 12 years and older. For children aged 4 to under 12 years, it is advised to consult a doctor, while the medication should not be used in children under 4 years of age.

Clinicians should counsel patients on the potential effects of the medication, including increased drowsiness when combined with alcohol, sedatives, or tranquilizers. Patients should be advised to exercise caution when driving or operating machinery. They should seek medical attention if they experience worsening symptoms such as persistent pain, nasal congestion, cough lasting more than 7 days, fever lasting more than 3 days, or the appearance of new symptoms. Additionally, patients should be instructed to take the medication only as directed, using the provided dose cup, and not to exceed 4 doses within a 24-hour period.

Drug Information (PDF)

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

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