Mucus Relief Dm Extended Release Caplets

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 expulsion of bothersome mucus and enhancing the productivity of coughs.

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

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

Dosage and Administration

Patients should take the tablets with a full glass of water. It is important to note that the tablets must not be crushed, chewed, or broken prior to ingestion. This medication can be administered without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period.

This medication is not recommended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Children under 12 years of age should not use this product due to safety concerns related to efficacy and potential adverse effects in this age group.

The product is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This is due to the risk of serious interactions that may occur when combining these medications. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised prior to use.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it should not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. This contraindication extends for a period of two weeks following the cessation of an MAOI. Healthcare professionals are advised to confirm whether a patient’s prescription includes an MAOI by consulting with the patient or their pharmacist prior to recommending this product.

Patients should be instructed to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

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

Serious adverse reactions may occur, and patients are advised to stop use and consult a healthcare professional if the cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

This product is contraindicated for use in children under 12 years of age and should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications. Patients uncertain about whether their prescription includes an MAOI should seek guidance from a doctor or pharmacist prior to use.

Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare professional before using this product. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical advice.

During the use of this product, it is crucial for patients to adhere strictly to the recommended dosage and not exceed the directed amount.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before use.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 1-800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Mucus Relief Dm Extended Release Caplets (guaifenesin, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. Caution is advised when prescribing to younger populations, as safety and efficacy have not been established in children under 12 years.

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 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment of the patient is essential to determine the appropriate course of action.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient’s vital signs and clinical status is recommended to ensure prompt identification and management of any complications that may arise.

In summary, immediate medical attention and appropriate management strategies are vital in addressing overdose cases effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed that various adverse reactions have been reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Additionally, instances of dizziness, nausea, and vomiting have been documented. Reports of confusion and hallucinations have also been noted. Furthermore, cases of respiratory depression and serotonin syndrome have been identified, particularly in patients using the medication in conjunction with other serotonergic drugs.

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. It is important to inform patients that this product is not recommended for use in children under 12 years of age.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. They should also refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. Additionally, it is advisable for patients to consult a doctor before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be encouraged to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a tamper-evident blister unit. It is essential to inspect the blister unit prior to use; do not use if the unit is torn, broken, or shows any signs of tampering.

For optimal storage, the product should be maintained at a temperature range of 20º to 25ºC (68º to 77ºF). It is recommended to keep the outer carton to ensure access to complete warnings and product information.

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 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 advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Mucus Relief Dm Extended Release Caplets, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)