Amazon Basic Care Mucus Dm

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may aid in promoting sleep.

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

Dosage and Administration

The extended-release tablet should be taken with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken, as this may affect the release mechanism of the medication.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 extended-release tablets every 12 hours, with a maximum of 4 extended-release tablets within a 24-hour period. This medication can be administered without regard to the timing of meals.

Use of this product is not recommended for children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product should not be used in excess of the directed dosage.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Healthcare professionals should ensure that patients are aware of this restriction to prevent potential adverse effects in younger populations.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease, should not use this product. Additionally, it is essential to refrain from using this product for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a patient's current medication regimen, it is advisable to consult a healthcare provider or pharmacist prior to use.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

For individuals who are pregnant or breastfeeding, it is crucial to seek advice from a healthcare professional before using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Serious adverse reactions may occur, and it is crucial to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

Warnings indicate that this product is not recommended for children under 12 years of age. Additionally, it should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. Patients uncertain about whether their prescription medication contains an MAOI should seek guidance from a doctor or pharmacist prior to use.

For pregnant or breastfeeding individuals, it is advised to consult a healthcare professional before using this product to ensure safety for both the patient and the child.

Drug Interactions

The concomitant use of dextromethorphan with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This combination may result in serious interactions, and it is advised that dextromethorphan not be used while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI.

No additional drug interactions or drug and laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Amazon Basic Care Mucus Dm (guaifenesin and dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There is insufficient data to support its safety and efficacy in this age group. Therefore, healthcare professionals are advised to avoid prescribing this treatment to children younger than 12 years.

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.

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 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 these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria; neurological effects including dizziness, confusion, hallucinations, and somnolence; gastrointestinal disturbances such as nausea, vomiting, constipation, and dry mouth; and cardiovascular events including increased blood pressure, tachycardia, and palpitations. Additionally, respiratory depression and serotonin syndrome have been noted.

Other reported reactions encompass fatigue, headache, insomnia, agitation, anxiety, depression, and suicidal thoughts, along with other neuropsychiatric events. The frequency of these adverse reactions is not known, and it is important to note that these reactions may not be directly attributable to the drug. Healthcare professionals are encouraged to report any adverse events or side effects to the FDA.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important for patients to stop using the product and consult a healthcare professional if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients who are pregnant or breastfeeding should be encouraged to consult with a healthcare professional prior to using this product. It is essential to instruct patients to adhere strictly to the recommended dosage and not exceed the directed amount while using this product.

Healthcare providers should also advise patients to consult a doctor before using the product if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be informed to seek medical advice 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 should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 1 or 2 extended-release tablets every 12 hours, not exceeding 4 tablets within a 24-hour period. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Amazon Basic Care Mucus Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)