Cold and Flu

Description

DG™ | health is a combination product designed to address symptoms associated with severe cold and flu. The daytime formulation contains Acetaminophen, Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl, serving as a pain reliever, fever reducer, cough suppressant, expectorant, and nasal decongestant. This formulation is available in a count of 16 caplets.

The nighttime formulation includes Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, and Phenylephrine HCl, functioning as a pain reliever, fever reducer, antihistamine, cough suppressant, and nasal decongestant. This formulation is available in a count of 8 caplets.

The product is distributed by Old East Main Co., located at 100 Mission Ridge, Goodlettsville, TN 37072. A tamper evident warning is included, advising against use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. Caution is advised to avoid taking the daytime and nighttime products simultaneously.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough, headache, sore throat, minor aches and pains, nasal congestion, sinus congestion and pressure, sneezing, and runny nose (for nighttime use only). It assists in loosening phlegm (mucus) and thinning bronchial secretions to enhance the productivity of coughs (for daytime use only). Additionally, it helps clear nasal passages, relieves cough to facilitate sleep, and temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets orally every 4 hours as needed. It is essential that the caplets are swallowed whole; they should not be crushed, chewed, or dissolved. The maximum allowable dosage is 10 caplets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician before administration.

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 advice from a healthcare professional.

• In individuals with a known allergy to this product or any of its ingredients, as this may result in an allergic reaction.

• Simultaneous use of DAYTIME and NIGHTTIME products is contraindicated to avoid potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, refrain from using other medications that also contain acetaminophen, and limit alcohol consumption to fewer than three drinks per day while using this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must 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 instructed to consult a physician promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be advised to consult a healthcare provider if they have high blood pressure, liver disease, diabetes, thyroid disease, heart disease, glaucoma (particularly at night), a cough that produces excessive phlegm, difficulty urinating due to prostate enlargement, or persistent cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with breathing problems such as emphysema or chronic bronchitis should seek medical advice before nighttime use.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present.

Patients should also be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if new symptoms arise; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, 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. If any of these symptoms occur, patients are advised to discontinue use and seek medical assistance immediately.

In clinical settings, patients experiencing severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare provider promptly. Additionally, patients should stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness, if pain, nasal congestion, or cough worsens or lasts more than seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if redness or swelling is present. A return of cough or occurrence of cough with rash or headache that lasts may indicate a serious condition requiring medical evaluation.

While using this product, patients may experience excitability, particularly in children, as well as marked drowsiness. Caution is advised when driving or operating machinery, especially at nighttime. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients with high blood pressure, liver disease, diabetes, thyroid disease, heart disease, glaucoma (at nighttime), or those experiencing cough with excessive phlegm, difficulty urinating due to prostate enlargement, or persistent cough associated with smoking, asthma, chronic bronchitis, or emphysema should consult a healthcare provider before use. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers (at nighttime) should seek advice from a doctor or pharmacist prior to use.

In the event of an overdose, it is critical for patients to obtain medical help or contact a Poison Control Center 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.

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 Parkinson's disease, as well as for a period of two weeks following the discontinuation of an MAOI.

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 nighttime, 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 Cold and Flu (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

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. 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 maternal health. 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. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

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 noticeable 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

If pregnant or breast-feeding, 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 that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include worsening pain, nasal congestion, or cough lasting more than 7 days, the emergence of new symptoms, fever that worsens or persists beyond 3 days, or the presence of redness or swelling. A cough that recurs or occurs alongside a rash or headache that lasts may indicate a serious condition.

In cases of overdose, it is imperative to seek medical help or contact a Poison Control Center without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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 take DAYTIME and NIGHTTIME products concurrently, as this could lead to adverse effects. It is important to communicate the necessity of adhering to the recommended dosage and to avoid exceeding it.

For those using the NIGHTTIME product, healthcare providers should inform patients that excitability may occur, particularly in children. Additionally, marked drowsiness is a potential side effect, and patients should be cautioned against consuming alcoholic beverages, as this may exacerbate drowsiness.

Patients should also be advised to exercise caution when driving or operating machinery while using the NIGHTTIME product, as drowsiness can impair their ability to perform these tasks safely. Furthermore, the use of alcohol, sedatives, and tranquilizers in conjunction with the NIGHTTIME product may increase drowsiness, and patients should be made aware of this risk.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). For proper inventory management, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed about the oral administration of the medication, which is indicated for adults and children aged 12 years and older. The recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period. It is important to swallow the caplets whole and not to crush, chew, or dissolve them. For children under 12 years, consultation with a healthcare professional is advised.

Clinicians should counsel patients on the importance of seeking medical advice if pregnant or breastfeeding. Additionally, the medication should be kept out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is critical for both adults and children. Parents are encouraged to educate themselves about the potential for medicine abuse among teens by visiting www.StopMedicineAbuse.org.

Drug Information (PDF)

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

View product document (PDF)