Vanacof Dm

Description

No description information is available for the 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 relieves the intensity of coughing and the impulse to cough, which may aid in promoting sleep. It also addresses nasal congestion associated with colds.

Limitations of use include the absence of teratogenic or nonteratogenic effects as per the available data.

Dosage and Administration

Adults and children 12 years of age and over are advised to take 15 mL (1 tablespoon) every 4 hours, with a maximum limit of 90 mL (6 tablespoons) within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 7.5 mL (1/2 tablespoon) every 4 hours, not to exceed 45 mL (3 tablespoons) in a 24-hour period.

For children under 6 years of age, it is essential to consult a healthcare professional before administration.

Dosing should be measured using the enclosed dosage cup or a tablespoon to ensure accuracy. It is imperative not to exceed the maximum number of doses, which is limited to 6 doses in any 24-hour period.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated while using this product.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when considering the use of this product.

Warnings The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

General Precautions Prior to use, patients should seek medical advice if they have any of the following conditions:

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• A chronic cough, particularly one associated with smoking, asthma, or emphysema

• A cough that produces excessive phlegm (mucus)

• Difficulty urinating due to prostate gland enlargement

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Discontinuation of Use Patients are advised to stop taking the product and consult a healthcare provider if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Symptoms that do not improve within seven days, or are accompanied by fever, rash, or a persistent headache

• The emergence of new symptoms

A persistent cough may indicate a serious underlying condition and should be evaluated by a healthcare professional.

Side Effects

Patients may experience a range of adverse reactions while using this product. It is important to monitor for serious symptoms that warrant immediate medical attention. Patients should stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache, medical advice should be sought. A persistent cough may indicate a serious underlying condition and should not be ignored.

Patients are advised against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If patients are uncertain whether their prescription includes an MAOI, they should consult a doctor or pharmacist prior to use.

Before using this product, patients should seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or if they experience a chronic cough associated with smoking, asthma, or emphysema. Furthermore, those with a cough that produces excessive phlegm or who have difficulty urinating due to prostate enlargement should also consult a healthcare professional.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. The combination may result in serious interactions that could pose significant health risks. It is essential to ensure that the patient has completed the appropriate washout period before initiating treatment with this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Vanacof Dm (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 7.5 mL (1/2 tablespoon) every 4 hours, with a maximum dosage not to exceed 45 mL (3 tablespoons) within a 24-hour period. For children under 6 years of age, it is advised to consult a doctor prior to 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 adverse effects or changes in therapeutic response, 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 currently no available data on 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness.

Additionally, symptoms that may indicate a serious condition have been noted, such as persistent cough, fever, rash, and persistent headache. It is advised that any new symptoms occurring during the use of this product should prompt consultation with a healthcare professional.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center 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 also be cautioned against using this product for 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.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if their symptoms do not improve within seven days or if they are accompanied by a fever, rash, or persistent headache. A persistent cough may indicate a serious condition, and any new symptoms that arise should also prompt a discussion with a healthcare provider.

When using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount. Furthermore, healthcare providers should encourage patients to consult with them prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a chronic cough associated with smoking, asthma, or emphysema, a cough that produces excessive phlegm, or difficulty urinating due to an enlarged prostate gland.

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 20-30°C (68-86°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)