Goodnow Cold and Flu Day Relief Cold and Flu Night Relief

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, runny nose, and sneezing.

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 6 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 remind patients of 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:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in 24 hours. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists beyond two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Individuals with persistent or chronic coughs, such as those related to smoking, asthma, or emphysema, should also seek medical advice. Furthermore, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical advice should be sought. Redness, swelling, the emergence of new symptoms, or a returning cough accompanied by rash or headache may indicate a serious condition and warrant immediate medical evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosage of 4,000 mg in 24 hours for adults or 5 doses in 24 hours for children. The risk is further heightened if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 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.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical advice should be sought. Signs such as redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache warrant immediate medical evaluation, as these may indicate a serious condition.

Prior to using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider. Those with a cough that produces excessive phlegm, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), glaucoma, breathing problems like emphysema or chronic bronchitis, or those on a sodium-restricted diet should also seek medical advice before use.

Patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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

Drug Interactions

Acetaminophen has the potential to increase the risk of liver damage when used concurrently with other medications containing acetaminophen or in individuals consuming three or more alcoholic beverages daily. It is advisable to monitor liver function in patients who are at risk.

Dextromethorphan may interact with monoamine oxidase inhibitors (MAOIs), which can lead to serious side effects. It is recommended to avoid the use of dextromethorphan in patients currently taking MAOIs or within two weeks of discontinuing them.

Warfarin, an anticoagulant, may have its anticoagulant effects modified when taken with acetaminophen or dextromethorphan. Close monitoring of International Normalized Ratio (INR) levels is essential in patients receiving these combinations to ensure therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Goodnow Cold and Flu Day Relief Cold and Flu Night Relief (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). 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 product is not recommended for children under 4 years of age.

For the Daytime Cold & Flu formulation, the dosing is as follows: children aged 6 to under 12 years may receive 15 mL every 4 hours, while those aged 4 to under 6 years should also seek medical advice prior to use. In contrast, adults and children aged 12 years and older can take 30 mL every 4 hours.

For the Nighttime Cold & Flu formulation, the recommended dosage for adults and children aged 12 years and older is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, in the event of an overdose, prompt medical attention is essential for children, even if no immediate signs or symptoms are present.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments or safety concerns. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if an adult exceeds a dosage of 4,000 mg of acetaminophen within a 24-hour period. For pediatric patients, the risk of severe liver damage increases if more than 5 doses are administered in a 24-hour timeframe.

Additionally, patients should be aware that the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage. Alcohol consumption further exacerbates this risk; adults who consume 3 or more alcoholic drinks daily while using this product may be at an increased risk for liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the potential risks and determine appropriate usage. Regular monitoring of liver function may be warranted in these individuals to ensure safety and efficacy.

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 depending 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.

Excitability may occur with the use of this product, particularly in children. Additionally, marked drowsiness has been observed, and the concomitant use of alcohol, sedatives, or tranquilizers may enhance this drowsiness.

No specific nonclinical toxicology data or animal pharmacology and toxicology data have been provided in the insert.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Severe skin reactions have been reported, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, 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, and tranquilizers.

New symptoms may arise that could indicate a serious condition, necessitating prompt medical attention. This is particularly critical in cases of overdose, where quick medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that quick medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose 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 exposure to extreme temperatures or environmental factors that may compromise the product's quality.

Additional Clinical Information

Patients aged 12 years and older are advised to take 30 mL every 6 hours for Night Relief and every 4 hours for Day Relief. For children aged 4 to under 12 years, it is recommended to consult a doctor regarding both Day and Night Relief. The product is not intended for use in children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)