Cough Relief

Description

Dextromethorphan hydrobromide (30 mg) serves as a cough suppressant, while doxylamine succinate (12.5 mg) functions as an antihistamine. The formulation contains 10% alcohol and is flavored with cherry. It is intended for use in individuals aged 12 years and older. The product features a tamper-evident design, and it should not be used if the printed safety seal around the dosage cup or under the cap is broken or missing.

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 effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 30 mL every 6 hours as needed. It is imperative that no more than 4 doses are taken within a 24-hour period.

The dosing cup provided with the product must be 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 adhere strictly to the dosing instructions provided and to take the medication only as directed.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as 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.

Warnings and Precautions

Patients should not use this product if they are 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 two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should advise patients to seek medical consultation before using this product if they have any of the following conditions: glaucoma; a cough that produces excessive phlegm (mucus); a history of breathing problems or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema; or difficulty urinating due to an enlarged prostate gland.

It is also important for patients to consult with a doctor or pharmacist before using this product if they are concurrently taking sedatives or tranquilizers, as these may interact with the product.

During the use of this product, patients may experience excitability, particularly in children, and marked drowsiness. Therefore, it is recommended that patients avoid alcoholic beverages, as well as exercise caution when driving or operating machinery. The concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients should 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 Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product may experience a range of adverse reactions. Serious adverse reactions include the potential for marked drowsiness, which may be exacerbated by the concurrent use of alcohol, sedatives, or tranquilizers. Participants should be advised to avoid alcoholic beverages while using this product, as these substances can significantly increase drowsiness.

Excitability has been reported, particularly in children, and caution is recommended when driving a motor vehicle or operating machinery due to the sedative effects of the product.

Patients are instructed to stop use and consult a healthcare professional 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 underlying condition.

Before using this product, patients should seek medical advice if they have a history of glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing difficulty urinating due to an enlarged prostate gland should also consult a healthcare provider prior to use.

It is critical to note that this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications, as this combination may lead to serious adverse effects.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs, which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of two weeks following the discontinuation of an MAOI.

Additionally, caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may potentiate drowsiness. Monitoring for increased sedation and potential impairment of cognitive and motor skills is recommended in patients receiving this combination. Adjustments to dosage or therapy may be necessary based on the clinical response and tolerance of the patient.

Packaging & NDC

Below are the non-prescription pack sizes of Cough Relief (dextromethorphan hbr, 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. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours. Caution is advised as excitability may occur, particularly in children, and marked drowsiness is a potential side effect. It is important to keep this product 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

Elderly patients may not have specific dosage adjustments or safety concerns outlined in the available prescribing information. However, it is important to note that the product is indicated for adults and children aged 12 years and older, suggesting that it may not have been specifically studied or recommended for geriatric patients.

Caution is warranted when administering this medication to elderly patients, as they may exhibit increased sensitivity to its effects, particularly with sedatives or tranquilizers. Marked drowsiness is a potential side effect that may be more pronounced in this population.

Healthcare providers should advise elderly patients to consult with their physician prior to use, especially if they have any underlying health conditions that could influence the safety or efficacy of the medication. Monitoring for adverse effects and adjusting treatment as necessary is recommended to ensure the well-being of geriatric patients.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance 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 medication. 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 should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdose situations.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential. Management procedures should be initiated based on the clinical presentation and the substance ingested. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate supportive care and symptomatic treatment as necessary.

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

Postmarketing Experience

Postmarketing experience has revealed reports of excitability, particularly in children. Additionally, marked drowsiness has been noted among patients. It has been observed that the concomitant use of alcohol, sedatives, and tranquilizers may increase the incidence of drowsiness.

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 includes an MAOI, they should be encouraged to consult their doctor or pharmacist.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying 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, given the potential for increased drowsiness when combined with alcohol, sedatives, or tranquilizers.

Healthcare providers should recommend that patients 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. Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. It is important to remind 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 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. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential 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 experience.

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)