Pharbinex-Dm

Description

PHARBEST is an immediate-release formulation containing Guaifenesin 400 mg and Dextromethorphan HBr 20 mg, serving as an expectorant and cough suppressant. This product is available in a dosage form of 30 tablets and is manufactured in the USA. PHARBEST is comparable to the active ingredient found in MUCINEX® DM Tablets. The National Drug Code (NDC) for this product is 73057-381-04.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to common colds. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and making coughs more productive.

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

Dosage and Administration

Patients should take this product with a full glass of water. It can be administered without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed, not to exceed 6 doses in a 24-hour period unless directed by a physician.

For children aged 6 to under 12 years, the recommended dosage is ½ tablet every 4 hours as needed, also not to exceed 6 doses in 24 hours unless advised by a healthcare professional.

For children under 6 years of age, it is advised to consult a doctor before administration.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised prior to use.

Additionally, the product should not be used in excess of the directed dosage. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this medication. It is imperative to consult a physician prior to use in patients with a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical advice before initiating treatment.

In the event of an overdose, immediate medical assistance is crucial. Healthcare providers should instruct patients to contact a Poison Control Center or seek emergency medical help without delay by calling 1-800-222-1222.

Patients should be advised to discontinue use and consult their healthcare provider if the 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 and management.

Side Effects

Patients should be aware of the potential 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 they experience a cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious illness.

Additionally, patients should seek medical advice before using this product if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. It is also important to consult a doctor if the cough is accompanied by excessive phlegm (mucus). These considerations are crucial for ensuring patient safety and effective management of 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 use this product while taking an MAOI or for a period 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 prescription medication contains an MAOI before using this product. This precaution is critical to avoid potential serious interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Pharbinex-Dm (guaifenesin 400mg and dextromethorphan hbr 20mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may take ½ tablet every 4 hours as needed. For children under 6 years of age, it is advised to consult a doctor before administration.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 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 may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance to ensure appropriate therapeutic levels while minimizing the risk of adverse effects. Regular renal function tests are recommended to monitor kidney function in patients receiving this medication. Additionally, special monitoring may be necessary for patients with severe renal impairment to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is recommended that liver function tests be monitored closely in this population to assess the impact of the drug on liver health. Caution should be exercised when administering the drug to patients with liver dysfunction, ensuring that any potential risks are carefully weighed against the benefits of treatment.

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 it is essential to monitor the patient closely for any signs of adverse reactions.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any symptoms present. Supportive care may be necessary, and specific antidotes or treatments should be administered as indicated based on the substance involved in the overdose.

Prompt action and appropriate medical care are vital to mitigate the potential risks associated with overdose.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 crucial to inform patients that this product 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. Patients should be instructed to refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult their doctor or pharmacist prior to using this product.

Providers should also recommend that patients consult a doctor before using this 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 advised to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

While using this product, patients must be reminded to adhere strictly to the directed dosage and not exceed it. They should be instructed to discontinue use and consult a doctor if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

Lastly, healthcare providers should emphasize the importance of consulting a health professional if the patient is pregnant or breastfeeding before using this product.

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 controlled temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures or humidity.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential 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 Pharbinex-Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)