Dollar General Chest Congestion Relief

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, imprinted with "XYZ" on one side and "123" on the other. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The tablets are supplied in bottles containing 100 units.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with a common cold. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this drug helps to make coughs more productive.

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 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that parents or guardians consult a doctor for children under 6 years of age before administration.

Healthcare professionals should advise patients not to exceed 6 doses within a 24-hour period unless directed otherwise by a physician.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or persistent headache. Additionally, if a cough persists for more than one week or tends to recur, medical advice should be sought.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, patients are advised to consult their healthcare provider or pharmacist prior to using this product.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Center immediately.

Patients are advised to discontinue use and consult their healthcare provider if any of the following symptoms occur: fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, it is essential to stop using the product and seek medical advice, as a persistent cough may indicate a serious underlying condition.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is crucial to avoid using this product if a patient is on an MAOI or has stopped taking one within the past two weeks. Patients uncertain about their medication should consult their doctor or pharmacist prior to use.

Common adverse reactions may include symptoms that warrant immediate medical attention. Patients are advised to stop use and consult a healthcare professional if symptoms are accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, it may indicate a serious underlying condition, and medical advice should be sought.

Before using this product, patients with a persistent or chronic cough—such as those associated with smoking, asthma, bronchitis, or emphysema—should consult their doctor. Furthermore, if the cough is accompanied by excessive phlegm (mucus), it is recommended that patients seek medical advice prior to use.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric or emotional conditions, and Parkinson's disease. Patients should not use this product while taking an MAOI or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with their healthcare provider or pharmacist if they are uncertain whether their current prescription medication contains an MAOI before using this product. This precaution is critical to avoid potential adverse interactions that may arise from the combination of these medications.

Packaging & NDC

Below are the non-prescription pack sizes of Dollar General Chest Congestion Relief (dextromethorphan hydrobromide / guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 10 years may take 1/2 tablet every 4 hours as needed. For children under 6 years of age, it is advised to consult a doctor before administration.

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 no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, it is essential for healthcare professionals to remain vigilant and exercise caution when administering this medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient for any potential symptoms that may arise, although specific symptoms have not been detailed in the available data.

Management of an overdosage situation should involve standard supportive care measures. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient is stable. In cases where the overdosage is suspected, immediate consultation with a poison control center or a medical toxicologist is advised to determine the most appropriate course of action.

Healthcare professionals are encouraged to report any observed adverse effects or complications related to overdosage to the relevant regulatory authorities to enhance the understanding of the medication's safety profile.

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. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Center immediately.

Patients should be informed to discontinue use and consult their doctor if they experience symptoms such as fever, rash, or a persistent headache. Additionally, they should be cautioned to stop use and seek medical advice if their cough persists for more than one week or tends to recur, as a persistent cough may indicate a serious underlying condition.

It is important for healthcare providers to recommend that patients consult their doctor before using this medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Furthermore, patients should be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

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 temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, with a maximum of six doses within a 24-hour period unless otherwise directed by a physician. For children aged 6 to 10 years, the dosage is half a tablet every four hours as needed, while children under 6 years of age should consult a doctor for appropriate dosing guidance.

Drug Information (PDF)

This file contains official product information for Dollar General Chest Congestion Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)