Meijer Maximum Strength Nighttime Cough Dm

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it provides temporary relief from symptoms related to hay fever or other upper respiratory allergies, including runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat. This drug also aids in controlling the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

The dosing of this product should be measured exclusively with the dosing cup provided, which must be kept with the product at all times. For adults and children aged 12 years and older, the recommended dosage is 20 mL every 6 hours, with a maximum of 4 doses within a 24-hour period. This product is not intended for use in children under 12 years of age; therefore, it is contraindicated for this population.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

This product should not be used to sedate children or induce sleepiness in pediatric patients. Additionally, it is contraindicated to exceed the recommended dosage. Concurrent consumption of alcoholic beverages is also discouraged, as alcohol, along with sedatives and tranquilizers, may enhance drowsiness.

Warnings and Precautions

The use of this product is associated with specific warnings and precautions that healthcare professionals must consider to ensure patient safety.

Warnings This product is contraindicated for use in children for the purpose of sedation or inducing sleepiness. Additionally, it must not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a patient's current medication regimen, consultation with a healthcare provider or pharmacist is essential prior to use.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions:

• Difficulty urinating due to an enlarged prostate gland.

• Glaucoma.

• A cough that produces excessive phlegm (mucus).

• Chronic respiratory issues, including a cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Furthermore, patients should be cautioned to seek guidance from a doctor or pharmacist if they are concurrently taking sedatives or tranquilizers, as these may interact with the product.

Emergency Medical Help Instructions 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.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product may experience marked drowsiness, which can be exacerbated by the consumption of alcoholic drinks, sedatives, or tranquilizers. It is advised that patients exercise caution when driving a motor vehicle or operating machinery due to the potential for increased drowsiness. Additionally, excitability may occur, particularly in children.

Patients should be aware of specific warnings regarding the use of this product. It is contraindicated for use in children for sedation purposes and should not be taken concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications. Patients uncertain about the presence of an MAOI in their prescription should consult a healthcare professional prior to use.

Patients are advised to discontinue use and seek medical advice 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 underlying condition.

Before using this product, patients with certain medical conditions should consult a healthcare provider. These conditions include difficulty urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or chronic respiratory issues such as asthma, chronic bronchitis, or emphysema. Furthermore, patients currently taking sedatives or tranquilizers should also seek guidance from a healthcare professional prior to use.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

Dextromethorphan has the potential to interact with monoamine oxidase inhibitors (MAOIs). This interaction may result in an increased risk of serious side effects. It is advised to avoid the use of dextromethorphan in patients who are currently taking MAOIs or have discontinued them within the past two weeks.

Concomitant use of doxylamine with alcohol, sedatives, or tranquilizers may enhance drowsiness. Patients are advised to exercise caution when driving or operating machinery while using doxylamine in combination with these substances.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Maximum Strength Nighttime Cough Dm (dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

Elderly patients may experience increased sensitivity to this adult product, which is not intended for use in individuals under 12 years of age. It is essential for geriatric patients to consult a healthcare provider prior to use, particularly if they have conditions such as difficulty urinating due to an enlarged prostate gland, glaucoma, or respiratory issues including chronic cough, asthma, chronic bronchitis, or emphysema.

Additionally, elderly patients should seek advice from a doctor or pharmacist if they are currently taking sedatives or tranquilizers, as these medications may interact with the product. Marked drowsiness is a potential side effect, and geriatric patients are advised to avoid alcoholic beverages, as the combination of alcohol with this product, along with sedatives and tranquilizers, may significantly enhance drowsiness. Caution is recommended when driving or operating machinery due to the increased risk of impaired alertness.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 drug 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.

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. Healthcare professionals are advised to contact a Poison Control Center without delay. The national hotline for poison control is available at 1-800-222-1222.

Prompt intervention is crucial in managing overdose situations to mitigate potential adverse effects. It is essential for healthcare providers to assess the patient's condition and initiate appropriate treatment protocols based on the specific circumstances 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 identified several adverse reactions reported voluntarily or through surveillance programs. These include drowsiness, excitability—particularly noted in children—various allergic reactions such as rash, itching, and swelling, as well as gastrointestinal disturbances including nausea and vomiting. Additionally, confusion and hallucinations have been reported in some patients, along with urinary retention, dry mouth and throat, and blurred vision.

Serious adverse events have also been documented, including instances of respiratory depression, seizures, and cardiac events. The safety profile of the product is under continuous monitoring, and updates will be provided as new information becomes available.

Patient Counseling

Healthcare providers should advise patients to keep the medication 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 must be cautioned not to exceed the recommended dosage. They should be made aware that marked drowsiness may occur and that the consumption of alcoholic beverages should be avoided, as alcohol, sedatives, and tranquilizers can enhance drowsiness. It is important to remind patients to exercise caution when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Healthcare providers should inform patients that excitability may occur, particularly in children. Patients should be advised to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

Patients should be encouraged to consult a doctor before using the medication if they have difficulty urinating due to an enlarged prostate gland, have glaucoma, or experience a cough that produces excessive phlegm (mucus). Additionally, patients with breathing problems or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use. Lastly, it is advisable for patients to consult a doctor or pharmacist if they are currently taking sedatives or tranquilizers.

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 to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 ml every 6 hours for adults and children aged 12 years and older. It is contraindicated for 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 Meijer Maximum Strength Nighttime Cough Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)