Cough and Chest Congestion Dm

Description

DEXTROMETHORPHAN HBr is a cough suppressant indicated for the control of cough. It is formulated with GUAIFENESIN, an expectorant that relieves chest congestion by thinning and loosening mucus. This product is intended for use in individuals aged 12 years and older. The dosage form is provided in fluid ounces (FL OZ) and includes a dosing cup for accurate measurement. The product is tamper evident; do not use if the printed safety seal around or under the cap is broken or missing. This formulation is not manufactured or distributed by Reckitt Benckiser, the distributor of Delsym® Cough+® Chest Congestion DM. It is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895.

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 expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the intensity of coughing and reduces the impulse to cough, which may aid in promoting sleep.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the following dosage and administration guidelines.

The recommended dosage for adults and children aged 12 years and older is 20 mL every 4 hours, with a maximum of 6 doses within a 24-hour period. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times to facilitate proper administration.

For children under 12 years of age, the product is not recommended for use. It is essential to follow these guidelines or any additional instructions provided by a healthcare professional.

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 they are uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated while using this product.

Warnings and Precautions

Use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed 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 headache that lasts. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation.

In the event of an overdose, it is imperative to obtain immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate the presence of a serious underlying condition that requires medical evaluation.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Patients should not take this product while on an MAOI or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Children under 12 years of age should not use this medication. For adults and pediatric patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours.

It is important 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 at 1-800-222-1222.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the absence of data necessitates careful clinical judgment and monitoring.

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 at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an 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 to address any complications that may arise during the course of treatment.

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 the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and allergic reactions, which include rash, itching, and swelling.

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.

Patients should be informed 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. Additionally, patients should 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 prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor 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 serious underlying condition.

It is important to remind patients to adhere strictly to the recommended dosage and not to exceed the directed amount when using this product.

Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if they have a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the safety seal around or under the cap before use; the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at a temperature range of 20-25ºC (68º-77ºF). It is crucial to avoid refrigeration, as this may compromise the product's integrity. The container should be stored in an upright position to ensure proper handling and to maintain the quality of the contents.

Once opened, the product should be discarded, as indicated by the handling instructions.

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. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)