Cough Dm

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or as a result of inhaled irritants. Additionally, it is indicated for the temporary relief of the impulse to cough, facilitating sleep.

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

Dosage and Administration

The bottle should be shaken well before use. Dosing must be measured exclusively with the dosing cup provided; the dosing cup should not be used with any other products to ensure accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 10 mL every 12 hours, with a maximum limit of 20 mL within a 24-hour period. For children aged 6 to under 12 years, the dosage is 5 mL every 12 hours, not to exceed 10 mL in a 24-hour period. For children aged 4 to under 6 years, the appropriate dose is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. This product is not recommended for use in children under 4 years of age.

Healthcare professionals should advise patients to follow these dosing guidelines or any specific instructions provided by their physician.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for 2 weeks following the discontinuation of an MAOI. 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.

Additionally, this product contains sodium metabisulfite, which may cause allergic-type reactions in individuals with sulfite sensitivity.

Warnings and Precautions

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. It is also contraindicated for a period of two weeks following the discontinuation of an MAOI. Patients uncertain about whether their prescription includes an MAOI should consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Allergy Alert This product contains sodium metabisulfite, a sulfite that may provoke allergic-type reactions in susceptible individuals.

General Precautions Healthcare professionals should advise patients to seek medical consultation before using this product if they have a chronic cough associated with smoking, asthma, or emphysema. Additionally, patients with a cough that produces excessive phlegm (mucus) should also consult a healthcare provider prior to use.

Emergency Situations 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.

Discontinuation of Use Patients are advised to discontinue use and consult a healthcare provider if any side effects occur. Side effects may be reported to the FDA at 1-800-FDA-1088. Furthermore, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, patients should seek medical attention, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients may experience adverse reactions associated with the use of this medication. Notably, there is an Allergy Alert due to the presence of sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

Patients are advised to discontinue use and consult a healthcare professional if any side effects occur. It is also recommended that patients seek medical attention if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache lasting longer than expected, as these symptoms could indicate a serious underlying condition.

For any adverse reactions, patients may report their experiences to the FDA at 1-800-FDA-1088.

Drug Interactions

Dextromethorphan is contraindicated in patients currently taking monoamine oxidase inhibitors (MAOIs) or those who have discontinued MAOIs within the past two weeks. The combination may lead to an increased risk of serious side effects. It is advised to avoid the use of dextromethorphan in these circumstances to prevent potential adverse reactions.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Cough Dm (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 5 mL every 12 hours, with a maximum dosage of 10 mL in a 24-hour period. For children aged 4 to under 6 years, the recommended dosage is 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours. The use of this medication is not recommended for children under 4 years of age.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined for the use of this medication. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this population.

It is advisable for healthcare providers to monitor elderly patients closely for any adverse effects or changes in therapeutic response, as individual patient factors may necessitate careful evaluation and management.

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 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 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 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 available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is crucial. Recommended actions include:

1. Assessment and Monitoring: Conduct a thorough evaluation of the patient, including vital signs and level of consciousness. Continuous monitoring may be necessary to detect any deterioration in the patient's condition.

2. Supportive Care: Initiate supportive measures as needed, which may include airway management, oxygen supplementation, intravenous fluids, and symptomatic treatment.

3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies tailored to the substance involved.

4. Decontamination: If appropriate and within a reasonable timeframe, decontamination procedures such as activated charcoal may be considered, provided the patient is alert and able to protect their airway.

5. Specific Antidotes: Be aware of any specific antidotes that may be indicated for the substance involved in the overdose, and administer them as per established protocols.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to act swiftly and effectively in managing potential overdose situations, utilizing a combination of assessment, supportive care, and consultation with specialists as necessary.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified various side effects associated with the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

Additionally, it has been noted that a cough persisting for more than 7 days, or a cough that recurs or is accompanied by fever, rash, or headache, may indicate the presence of a serious underlying 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 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 at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Providers should alert patients to the presence of sodium metabisulfite in the formulation, which may trigger allergic-type reactions in susceptible individuals. Patients must be instructed to discontinue use and consult a doctor if they experience any side effects. They should also be informed that side effects can be reported to the FDA at 1-800-FDA-1088.

Additionally, healthcare providers should advise patients to stop using the product and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition. Patients with a chronic cough associated with smoking, asthma, or emphysema should be encouraged to consult a doctor before using this product. Furthermore, patients should be advised to seek medical guidance if they have a cough that is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a bottle that requires careful handling and storage to maintain its efficacy. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Prior to use, the bottle must be shaken well to ensure proper mixing of the contents.

For accurate dosing, it is essential to measure only with the dosing cup provided with the product. The dosing cup should not be used with any other products to prevent cross-contamination and ensure precise dosing.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 10 mL every 12 hours, with a maximum of 20 mL in a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 12 hours, not exceeding 10 mL in 24 hours. Children aged 4 to under 6 years should receive 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. The medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to consult a doctor prior to use if they have a chronic cough associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive mucus. Pregnant or breastfeeding patients should also seek advice from a healthcare professional before use. Patients are instructed to discontinue use and consult a doctor if side effects occur, with the option to report adverse effects to the FDA at 1-800-FDA-1088.

Drug Information (PDF)

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

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