Cough Relief

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cold symptoms, including cough due to minor throat and bronchial irritation, as well as runny nose and sneezing.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 30 mL administered every 6 hours. It is imperative that no more than 4 doses are taken within a 24-hour period.

Healthcare professionals should instruct patients to measure the dosage exclusively with the dosing cup provided with the product, as the use of any other dosing device is not advised. The dosing cup should be kept with the product to ensure proper measurement.

For children under 12 years of age, the product is not recommended for use. Patients should be advised to take the medication only as directed to ensure safety and efficacy.

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 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a minimum of two weeks following the cessation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Before initiating treatment, it is essential for healthcare providers to assess the patient's medical history. Patients should be advised to seek medical guidance prior to use if they have any of the following conditions: glaucoma, a cough associated with excessive phlegm (mucus), chronic respiratory issues such as asthma, chronic bronchitis, or emphysema, or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should consult a doctor or pharmacist if they are concurrently using sedatives or tranquilizers, as these may interact with the product.

During the use of this product, healthcare professionals should inform patients that excitability may occur, particularly in children, and that marked drowsiness is a potential side effect. Patients are advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers can exacerbate drowsiness.

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 persistent headache, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious warnings include the contraindication of use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication, as this may lead to significant interactions.

Common adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are advised to avoid alcoholic beverages while using this product, as alcohol, along with sedatives and tranquilizers, may exacerbate drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for impaired alertness.

Patients with specific medical conditions should consult a healthcare professional prior to use. This includes individuals with glaucoma, those experiencing a cough with excessive phlegm, or those with chronic respiratory issues such as asthma, chronic bronchitis, or emphysema. Additionally, patients who have difficulty urinating due to an enlarged prostate gland should seek medical advice before using this product.

Patients are instructed to discontinue use and consult a doctor 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.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this product while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI, as this may result in serious interactions.

Additionally, caution is advised when using this product in conjunction with alcohol, sedatives, or tranquilizers. The combination may enhance drowsiness, necessitating careful monitoring of the patient's level of sedation and potential impairment in motor skills. Adjustments to dosage or the timing of administration may be required to mitigate these effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product. Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness may be experienced.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the 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 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 medical assistance promptly. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for immediate guidance and support.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Management of an overdose should be tailored to the individual case, taking into account the substance, the amount ingested, and the time elapsed since ingestion.

Prompt intervention is crucial in mitigating potential complications associated with overdose. Continuous monitoring and supportive care may be necessary, depending on the severity of symptoms presented.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability has been observed, particularly in pediatric populations. Additionally, marked drowsiness may occur, which can be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers.

No specific information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Furthermore, there is no detailed data provided on animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: excitability, particularly in children, and marked drowsiness. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Patients should be advised to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important 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.

Patients should be instructed 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 persistent headache, as these symptoms may indicate a serious condition.

When using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery. Additionally, patients should be informed that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have glaucoma, a cough that produces excessive phlegm, a breathing problem, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Lastly, patients taking sedatives or tranquilizers should be advised to consult with their doctor or pharmacist before using this product.

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 a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 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 to consult a health professional if they are pregnant or breastfeeding. Additionally, it is crucial to keep the medication out of reach of children. 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 Cough Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)