Walgreen

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 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. It also alleviates nasal congestion associated with colds.

There are no teratogenic or nonteratogenic effects reported for 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 or frequency.

For children under 12 years of age, the use of this medication is not recommended.

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

It is imperative that this product not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be taken for at least 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 current prescription medications.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients experiencing a cough that produces excessive phlegm (mucus) should also consult a healthcare professional before use.

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.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by a fever, or if a cough recurs or is associated with a rash or persistent headache, these may indicate a serious condition requiring medical evaluation.

Side Effects

Patients may experience a range of adverse reactions while using the medication. 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. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by a fever, it is advised to seek medical advice. A return of cough, particularly if it is associated with a rash or persistent headache, may indicate a serious underlying condition and should also prompt consultation with a healthcare provider.

Common adverse reactions may include those related to pre-existing health conditions. Patients are advised to consult a doctor before using the medication 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, should seek medical advice prior to use. Coughs that produce excessive phlegm (mucus) also necessitate a discussion with a healthcare professional before starting the medication.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Walgreen (dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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 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.

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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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. The national helpline for poison control can be reached at 1-800-222-1222.

Prompt intervention is crucial in managing overdose situations. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management of an overdose typically involves supportive care and may require specific antidotes or treatments based on the clinical presentation. Continuous monitoring of the patient’s vital signs and symptoms is essential to ensure appropriate care and intervention.

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 nervousness, dizziness, sleeplessness, rash, and persistent headache.

These reactions may occur in patients using the product and could potentially indicate the presence of a serious condition.

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 instruct patients not to exceed the recommended dosage.

Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to seek medical advice if their symptoms do not improve within 7 days, if they develop a fever, or if their cough returns or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult with a doctor prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical guidance 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 children under 12 years of age. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding. 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 Walgreen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)