Equaline Mucus Dm

Description

Guaifenesin and dextromethorphan hydrobromide are combined in an extended-release tablet formulation, delivering 1200 mg of guaifenesin and 60 mg of dextromethorphan hydrobromide per tablet. This combination serves as an expectorant and cough suppressant, providing relief for up to 12 hours. Guaifenesin functions by thinning and loosening mucus, while dextromethorphan hydrobromide effectively controls cough.

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 help patients achieve restful sleep.

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

Dosage and Administration

The tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended to administer the tablet with a full glass of water. This product can be taken without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. The use of this product is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Children under 12 years of age.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past 2 weeks. Due to the potential for serious interactions, it is advised to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in any prescription medication.

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

It is imperative to adhere to the following general precautions. This product is not recommended for use in children under 12 years of age. Additionally, it should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Furthermore, this product should not be taken for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional, such as a doctor or pharmacist, is advised prior to use.

Healthcare professionals should instruct patients 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, as these symptoms may indicate a more serious underlying condition.

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

Patients should be aware that a cough lasting more than 7 days, returning after resolution, or occurring alongside fever, rash, or persistent headache may indicate a serious underlying illness that requires medical evaluation.

In addition to the aforementioned warnings, participants may experience persistent or chronic cough, which can be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Furthermore, a cough that is accompanied by excessive phlegm (mucus) may also occur. These adverse reactions should be monitored closely, and patients are advised to seek medical attention if they experience any concerning symptoms.

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, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Equaline Mucus Dm (dextromethorphan hbr, guaifenesin). 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 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period.

It is essential to keep this 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.

Geriatric Use

Caution should be exercised when administering this product to elderly patients, as geriatric use has not been specifically studied. Elderly patients may exhibit increased sensitivity to side effects, necessitating careful monitoring for adverse reactions.

Additionally, dosage adjustments may be necessary due to the potential for reduced kidney function in this population. Healthcare providers should consider renal function when determining the appropriate dosage for geriatric patients to ensure safety and 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 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that renal function is monitored regularly in these patients. Dosage adjustments should be based on creatinine clearance levels, ensuring that appropriate modifications are made to optimize therapeutic outcomes. Special consideration should be given to patients with severe renal impairment, as they may require more stringent management. Renal function tests should be performed prior to initiating therapy and periodically thereafter to assess any changes in renal status.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in these patients regularly to assess their liver status and adjust treatment as necessary. Caution should be exercised when administering the medication to individuals with liver problems, particularly those with moderate to severe hepatic impairment, as a reduced dose may be necessary in these cases to mitigate the risk of adverse effects.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 several adverse reactions associated with the product, reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Other reported effects involve hallucinations, confusion, agitation, increased heart rate, respiratory depression, seizures, and hepatotoxicity, along with various central nervous system effects. The frequency of these adverse reactions is not known. Additional safety information may be obtained from the manufacturer.

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.

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 illness.

When using this product, patients must be reminded not to exceed the recommended dosage. Additionally, it is advisable for patients to consult a doctor prior to use 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 packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed foil under the cap is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours for adults and children aged 12 years and older, not exceeding two tablets within a 24-hour period. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients to consult a healthcare 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 experiences.

Drug Information (PDF)

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

View product document (PDF)