Vanacof Xp Cough / Chest Congestion

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 aids 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 assist patients in achieving restful sleep.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 15 mL (1 tablespoon) administered every 4 hours, with a maximum of 90 mL (6 tablespoons) in a 24-hour period. For children aged 6 to under 12 years, the dosage is 7.5 mL (1/2 tablespoon) every 4 hours, not to exceed 45 mL (3 tablespoons) within a 24-hour timeframe.

For children under 6 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

It is imperative that no more than 6 doses are taken within any 24-hour period to avoid potential overdose.

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.

Furthermore, the product should not be used in excess of the directed dosage.

Warnings and Precautions

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, it should not be used within two weeks of discontinuing an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

General precautions should be observed prior to use. Patients should be instructed to seek medical advice if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider before using this product.

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

Patients are advised 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 headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is crucial to avoid using this product if a patient is taking an MAOI or has stopped taking one within the past two weeks. Patients uncertain about whether their prescription includes an MAOI should consult a healthcare professional before use.

Common adverse reactions may include a persistent cough. Patients are advised to stop using the product and seek medical advice if their cough lasts more than seven days, recurs, or is accompanied by fever, rash, or a headache that persists, as these symptoms could indicate a serious underlying condition.

Additionally, patients should consult a healthcare provider prior to use if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

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

Drug Interactions

The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are necessary beyond the contraindication noted above.

Packaging & NDC

Below are the non-prescription pack sizes of Vanacof Xp Cough / Chest Congestion (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should consult a doctor before use. For children aged 6 to under 12 years, the recommended dosage is 7.5 mL (1/2 tablespoon) every 4 hours, with a maximum of 45 mL (3 tablespoons) in a 24-hour period. In contrast, adults and children 12 years of age and older may take 15 mL (1 tablespoon) every 4 hours, not exceeding 90 mL (6 tablespoons) within 24 hours.

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 without delay.

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, 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 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

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 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. 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 alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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 identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Additionally, cases of hallucinations, confusion, agitation, increased heart rate, and respiratory depression have also been documented.

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 within two weeks of stopping 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.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a more serious underlying condition.

While using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount. Additionally, healthcare providers should advise patients to consult a doctor before using this product if they have a cough that is chronic, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, or 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 temperature range of 20° to 30°C (68° to 86°F) to ensure optimal stability and efficacy. Proper container requirements must be adhered to, and special handling needs should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)