Safetussin Non Drowsy

Description

Safetussin® DM is a cough suppressant and expectorant formulation containing Dextromethorphan HBr at a concentration of 10 mg and Guaifenesin at 100 mg per dosage unit. The product is presented in a liquid dosage form, with a total volume of 8.0 FL OZ (237 mL). It is specifically designed to be free from sugar, alcohol, decongestants, acetaminophen, sorbitol, fructose, gluten, and dyes. This formulation is recommended by pharmacists, ensuring a trusted option for managing cough and promoting expectoration without the inclusion of common allergens or additives.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation. It also aids in loosening phlegm (mucus) and facilitates the clearance of bronchial passages of phlegm (mucus).

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 over is 10 mL administered every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose. This product is not intended for use in children under 12 years of age; therefore, it should not be administered to this population. Healthcare professionals should ensure that patients are aware of these guidelines to promote safe and effective use of the medication.

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 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 are advised to confirm whether a patient’s prescription includes an MAOI by consulting with a doctor or pharmacist prior to administration of this product.

Healthcare providers should exercise caution and recommend that patients seek medical advice before using this product if they experience a cough accompanied by excessive phlegm (mucus) or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

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 additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs). It is contraindicated to use this product concurrently with MAOIs or within 2 weeks of discontinuing such medication. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions may include a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms could indicate a serious underlying condition, and patients should discontinue use and seek medical advice if they experience these signs.

Additionally, patients should consult a healthcare provider prior to use if they have a cough associated with excessive phlegm or if they have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. These conditions may require further evaluation and management.

Drug Interactions

The concomitant use of this product with prescription 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 MAOIs 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, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Safetussin Non Drowsy (dextromethorphan hydrobromide, and guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product, as it is intended solely for adult use. There are no established safety or efficacy profiles for this medication in children within this age group.

Geriatric Use

Elderly patients should be aware that this adult product is not intended for use in children under 12 years of age. It is essential for geriatric patients to consult with a healthcare provider regarding any individual health questions or concerns prior to use. This ensures that any potential risks or necessary precautions are adequately addressed, particularly given the unique health considerations that may arise in 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 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 safe use during pregnancy and lactation.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert text. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance may necessitate individualized assessment and monitoring based on clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely for any signs of toxicity and initiate appropriate interventions based on the clinical presentation. It is advisable to have access to the relevant product information and guidelines to inform treatment decisions effectively.

In summary, timely medical intervention and careful monitoring are critical components in the management of overdose cases.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. 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 seek medical advice if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Additionally, patients should be advised to consult a doctor before using this medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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 15° to 30°C (59° to 86°F). Care should be taken to protect the product from excessive heat and freezing to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 10 mL every hour for adults and children aged 12 years and older. Patients should not exceed 6 doses within a 24-hour period.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential for patients to read and adhere to label directions, and they should not use the medication for more than 7 consecutive days unless directed by a physician. Patients are encouraged to seek medical advice for any individual health concerns.

Drug Information (PDF)

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

View product document (PDF)