Family Dollar Nighttime Cold and Flu Relief

Description

No description information is available for the 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, as well as runny nose and sneezing.

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

Dosage and Administration

Patients should take the medication only as directed and utilize the dose cup provided for accurate measurement.

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 physician for appropriate dosing recommendations.

The medication is not indicated for use in children under 4 years of age.

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) for depression, psychiatric, or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious drug interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 4 doses within a 24-hour period. Patients should be cautioned against taking this product in conjunction with other medications containing acetaminophen, as well as against consuming three or more alcoholic drinks daily while using 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 discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions should be taken when considering the use of this product. Patients should be instructed to consult a healthcare provider prior to use if they have a history of liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, particularly chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before use.

Patients should also be encouraged to consult a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin, as interactions may occur.

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, even if no signs or symptoms are apparent.

Patients must be advised to discontinue use and contact a healthcare professional if pain 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 arise, or if a cough recurs alongside 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 if patients exceed four doses in a 24-hour period, which is the maximum daily amount for this product, or if they use it in conjunction with other drugs containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may increase the risk of liver damage.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients are advised 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 should consult a doctor promptly.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a possibility. Patients are cautioned to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should discontinue use and consult a doctor if pain or cough 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 arise, or if a cough recurs or occurs with a rash or headache that lasts, as these may indicate a serious condition.

Before using this product, patients should seek medical advice if they have liver disease, glaucoma, a cough that produces excessive phlegm, a breathing problem or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if they experience difficulty urinating due to an enlarged prostate gland. Additionally, patients should consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Family Dollar Nighttime Cold and Flu Relief (acetaminophen, dextromethorphan hbr, doxylamine succinate). 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 using this product. It is contraindicated in children under 4 years of age.

When using this product, there is a potential for excitability, particularly in pediatric patients.

In cases of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately 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.

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 on the excretion of this drug 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 difficulties with urination 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 be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, it is recommended that patients limit alcohol consumption to fewer than 3 drinks per day while using this product to mitigate the risk of liver damage. Regular assessment of liver function may be warranted in patients with hepatic impairment to ensure safety and efficacy during treatment.

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 lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

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, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, if they notice any redness or swelling, or if new symptoms arise. Additionally, they should be advised to seek medical attention if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned against consuming alcoholic beverages while using this product, as well as being careful when driving or operating machinery due to the potential for increased drowsiness, especially when combined with alcohol, sedatives, or tranquilizers.

Patients should be encouraged to consult a doctor before using this product if they have liver disease, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. They should also seek medical advice if they experience difficulty urinating due to an enlarged prostate gland, or if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

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 not refrigerated. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 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 regarding appropriate dosing, while the use of this medication is not recommended for 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 medication 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 medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)