Tussin

Description

Tussin MULTI-SYMPTOM COLD CF is a combination medication formulated to relieve symptoms associated with cold and cough. The active ingredients include Dextromethorphan HBr, a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. This product is designed to alleviate cough, mucus production, and nasal congestion.

The formulation is characterized as non-drowsy and alcohol-free, and it includes a dosing cup for accurate measurement. The product is packaged in fluid ounces (FL OZ) and milliliters (mL). A tamper evident warning is provided, indicating that the product should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing.

Tussin MULTI-SYMPTOM COLD CF is proudly distributed by Valu Merchandisers, Co., located at 5000 Kansas Ave, Kansas City, KS 66106. Additional information can be found on the website www.bestchoicebrand.comwww.bestchoicebrand.com.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically nasal congestion and cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

Adults and children 12 years and older are advised to take 10 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. The dosing must be measured exclusively with the dosing cup provided with the product; the use of any other dosing device is not recommended. The dosing cup should be kept with the product to ensure accurate measurement.

This product is not intended for use in children under 12 years of age.

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. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised prior to use.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this medication.

Warnings The use of this medication is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this medication should not be taken 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 there is uncertainty regarding the presence of an MAOI in their prescription medications.

General Precautions Prior to using this medication, patients should seek medical advice if they have any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a cough that is productive with excessive phlegm. Furthermore, individuals with a chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider. It is also advisable to inquire with a doctor or pharmacist before use if the patient is currently taking any other oral nasal decongestants or stimulants.

Emergency Medical Help Instructions 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.

Stop Taking and Call Your Doctor Instructions Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, medical advice should be sought. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, these may indicate a serious condition requiring medical attention.

Before using this product, patients with a history of heart disease, diabetes, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland should seek medical advice. Furthermore, individuals with a cough that produces excessive phlegm or those with chronic cough conditions, such as smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider prior to use.

It is contraindicated to use this product in conjunction with a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Patients uncertain about whether their prescription medication contains an MAOI should consult a doctor or pharmacist. Caution is also advised for those taking any other oral nasal decongestants or stimulants.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients currently taking MAOIs, which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, should not use this medication. Additionally, it is advised to wait at least two weeks after discontinuing an MAOI before initiating treatment with this medication to avoid potential adverse effects.

Furthermore, patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are concurrently taking any other oral nasal decongestants or stimulants. This precaution is essential to ensure safety and to mitigate the risk of adverse interactions.

Packaging & NDC

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

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

Elderly patients may require special consideration when using this product. It is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 10 mL every 4 hours.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, particularly those with pre-existing conditions. It is advisable to consult a physician prior to use in individuals with heart disease, diabetes, high blood pressure, thyroid disease, or those experiencing difficulties urinating due to an enlarged prostate gland. Monitoring for potential adverse effects and efficacy is recommended in this population to ensure safe and effective use.

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 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 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 individuals 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 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 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. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms do not improve within seven days or if they are accompanied by fever. It is important to inform patients that they should also stop 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 may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Lastly, patients should be reminded to consult a doctor or pharmacist before using this product if they are taking any other oral nasal decongestants or stimulants.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not permitted for this product. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 10 mL every 4 hours for adults and children aged 12 years and older. It is not recommended for use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. 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 experience.

Drug Information (PDF)

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

View product document (PDF)