Night Time Cough

Description

DEXTROMETHORPHAN HBr is a cough suppressant indicated for the relief of cough, sneezing, and runny nose. It is combined with DOXYLAMINE SUCCINATE, an antihistamine that enhances the therapeutic effect. The formulation is presented in a cherry-flavored liquid dosage form, containing 10% alcohol. This product is intended for use in individuals aged 12 years and older. The volume of the product is measured in fluid ounces (FL OZ) and milliliters (mL).

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

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.

For children under 12 years of age, the product is not recommended for use. It is essential to follow the dosing instructions as directed.

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. Due to the potential for serious interactions, patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

The 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. Additionally, it should not be used for a period of two weeks following the discontinuation 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.

General precautions should be observed prior to use. Patients should seek medical advice if they have a history of glaucoma, a cough that produces excessive phlegm (mucus), or any breathing issues, including chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing difficulty urinating due to an enlarged prostate gland should also consult a healthcare provider. It is advisable for patients to discuss their use of sedatives or tranquilizers with a doctor or pharmacist before taking this product.

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.

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.

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. Patients are advised to avoid alcoholic beverages while using this product, as these substances can significantly increase drowsiness. Additionally, patients should exercise caution when driving a motor vehicle or operating machinery due to the risk of impaired alertness.

Commonly reported side effects include excitability, particularly in children. Patients should be aware that if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, they should discontinue use and consult a healthcare professional, as these symptoms may indicate a serious underlying condition.

It is important for patients to consult a doctor before using this product if they have certain pre-existing conditions, such as glaucoma, a cough associated with excessive phlegm, or chronic respiratory issues like asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice prior to use.

Patients currently taking prescription monoamine oxidase inhibitors (MAOIs) or who have recently discontinued such medications within the past two weeks should not use this product, as serious interactions may occur.

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 or for a period of two weeks following the discontinuation of MAOI therapy. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease.

Caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may potentiate drowsiness. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking sedatives or tranquilizers to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Night Time Cough (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. Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness has been reported, which may impact the safety and efficacy of the treatment in this population.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 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 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 drug. 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 or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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: excitability, particularly in children, and marked 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, recurs, 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.

Additionally, patients should be encouraged to consult their healthcare provider before using this product if they have any of the following conditions: glaucoma, a cough that produces excessive phlegm (mucus), breathing problems or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or difficulty urinating due to an enlarged prostate gland. It is also advisable for patients to seek guidance from 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 storage conditions must be maintained to ensure optimal 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 who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important 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 Night Time Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)