Dg Day Time Cold and Flu Formula and Night Time Cold and Flu Formula

Description

DG Day and Night Cold and Flu Formula is a combination product designed to alleviate symptoms associated with cold and flu. It is formulated to provide relief during both day and night, featuring active ingredients comparable to those found in Alka-Seltzer PLUS® Day and Night Cold and Flu Formula. The product is identified by the National Drug Code (NDC) 51013-168-08.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or flu, including minor aches and pains, headache, nasal and sinus congestion, cough, sore throat, and runny nose and sneezing (for nighttime use only). Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 softgels with water every 4 hours as needed. The total daily dosage must not exceed 10 softgels within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. It is imperative that patients adhere strictly to the recommended dosage and frequency to avoid potential adverse effects.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, seek guidance from a healthcare professional.

• In individuals with a known history of allergic reactions to this product or any of its components, to prevent potential severe allergic responses.

• In children under 12 years of age, due to safety concerns and lack of established efficacy in this population.

Warnings and Precautions

Severe liver damage may occur with the use of products containing acetaminophen if the following conditions are met: exceeding the maximum daily dosage of 10 softgels within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

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

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, the product should be discontinued immediately, and medical assistance sought. It is important to note that this product should not be used to sedate children, particularly in formulations labeled for Night Time use.

Healthcare professionals should advise patients to seek medical guidance prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or glaucoma (specifically for Night Time formulations). Additionally, patients should consult a doctor or pharmacist if they are taking blood thinners such as warfarin or sedatives/tranquilizers, particularly in Night Time formulations.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain, cough, or nasal congestion lasting more than seven days; fever that worsens or persists beyond three days; presence of redness or swelling; emergence of new symptoms; recurrence of cough accompanied by rash or headache; or the onset of nervousness, dizziness, or sleeplessness. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 10 softgels within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should discontinue use and seek medical assistance immediately.

Patients are instructed to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling is present, if new symptoms occur, or if a cough returns or occurs with a rash or headache that lasts. Symptoms such as nervousness, dizziness, or sleeplessness should also prompt patients to seek medical advice.

While using this product, patients should not exceed the recommended dosage, as it may cause marked drowsiness. Alcoholic beverages, sedatives, and tranquilizers may enhance drowsiness, and caution is advised when driving a motor vehicle or operating machinery. Excitability may occur, particularly in children.

Patients with a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or glaucoma should consult a doctor before use. Additionally, patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should seek advice from a doctor or pharmacist prior to using this product.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, 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) for depression, psychiatric, or emotional conditions, or for Parkinson's disease. It is advised to wait at least two weeks after discontinuing an MAOI before initiating this medication to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, individuals using sedatives or tranquilizers, particularly at night, should seek advice from a healthcare provider before use. The combination of alcohol, sedatives, and tranquilizers with this medication may enhance drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Day Time Cold and Flu Formula and Night Time Cold and Flu Formula (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is contraindicated for sedation purposes in children and is intended for Night Time use only. Prior to administration, it is essential to consult a healthcare professional if the pediatric patient has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, difficulty urinating due to prostate enlargement, persistent or chronic cough (including those associated with smoking, asthma, or emphysema), glaucoma, or any breathing problems such as emphysema or chronic bronchitis, particularly for Night Time use.

Excitability may occur in pediatric patients, and caregivers should be vigilant for this side effect. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay, as prompt attention is crucial for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 10 softgels in a 24-hour period. Exceeding this dosage, using other medications that contain acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients to ensure safety and prevent potential adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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. Overall, the nonclinical toxicology data is currently insufficient to draw any conclusions regarding these aspects.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms include 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. Users are encouraged to stop use and consult a healthcare professional if any of the following occur: worsening pain, cough, or nasal congestion lasting more than 7 days; fever worsening or persisting beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting longer than usual, as these may indicate a serious condition.

Other reported adverse events include nervousness, dizziness, and sleeplessness.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. When discussing the use of Night Time, healthcare providers should inform patients that the medication may cause marked drowsiness. It is important to advise patients to avoid alcoholic beverages, as the combination of alcohol, sedatives, and tranquilizers can significantly enhance drowsiness.

Additionally, healthcare providers should caution patients about the potential risks associated with driving a motor vehicle or operating machinery while using this medication. They should also be aware that excitability may occur, particularly in children, and should be prepared to monitor for this effect.

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 room temperature, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper handling should be observed to prevent any potential degradation of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

View product document (PDF)