Walgreens Maximum Strength Severe Congestion and Cough

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 helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and alleviates nasal congestion associated with colds. It is designed to help reduce the frequency of coughing episodes.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Healthcare professionals should instruct patients to measure the medication exclusively with the dosing cup provided, and to refrain from using this cup with any other products to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. It is imperative that patients do not exceed the specified dosage.

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

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 to ensure the safe 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 using this product, patients should seek medical advice if they have any of the following conditions:

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Difficulty urinating due to an enlarged prostate gland

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

• A cough that is accompanied by excessive phlegm (mucus)

Emergency Medical Help Instructions In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at (1-800-222-1222).

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a healthcare professional if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Symptoms that do not improve within seven days or are accompanied by fever

• A cough that recurs or is associated with a rash or persistent headache, as these may indicate a serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a healthcare professional if these symptoms occur, if symptoms do not improve within 7 days, or if they are accompanied by fever. Additionally, a cough that recurs or is associated with a rash or a persistent headache may indicate a serious underlying condition and should be evaluated by a physician.

It is contraindicated to use this product in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should not use this product for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to 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 difficulty urinating due to an enlarged prostate gland. Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or those experiencing a cough with excessive phlegm (mucus) should also consult a healthcare professional prior to use.

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, as this may result in serious interactions.

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

Packaging & NDC

Below are the non-prescription pack sizes of Walgreens Maximum Strength Severe Congestion and Cough (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). 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 20 mL, administered using the dosing cup provided, every 4 hours.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 the safety of both the mother and the developing fetus.

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 studied in relation to dosage adjustments, special monitoring, or safety considerations. Therefore, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

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

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay at (1-800-222-1222) for guidance on managing the situation.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective resolution of the overdose.

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 several adverse reactions have been reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, rash, and headache. Such reactions may occur in patients using the product.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. 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 inform patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to seek medical advice if their symptoms do not improve within seven days or if they are accompanied by fever. They should also be instructed to stop use and contact a doctor if a cough returns or occurs with a rash or persistent headache, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should also recommend that patients consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product. Lastly, patients should be advised to consult a doctor if they have a cough that produces excessive phlegm (mucus).

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 room temperature, ensuring that it is not exposed to refrigeration. Proper handling should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in 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).

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Walgreens Maximum Strength Severe Congestion and Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)