Robitussin Peak Cold Multi-Symptom Cold

Description

Robitussin PEAK COLD Multi-Symptom Cold is a pharmaceutical formulation designed for the relief of cough, nasal congestion, and mucus. The product contains three active ingredients: Dextromethorphan HBr, which serves as a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. This formulation is classified as Non-Drowsy CF, making it suitable for use during the day. It is indicated for individuals aged 12 years and older. The product is available in a volume of 4 fluid ounces (118 ml).

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 aged 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 cup provided with the product must be used for accurate measurement; it should be kept with the product at all times to ensure proper dosing.

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 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.

Exceeding the recommended dosage is also contraindicated while using this product.

Warnings and Precautions

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 cessation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

Patients should seek medical advice prior to using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, 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 before use.

It is essential for patients to inform their healthcare provider or pharmacist if they are currently taking any other oral nasal decongestants or stimulants, as this may affect the safety and efficacy of the product.

Patients must adhere strictly to the recommended dosage and should not exceed the directed amount.

If any of the following occur, patients should discontinue use and consult a healthcare professional: feelings of nervousness, dizziness, or sleeplessness; lack of improvement in symptoms within seven days; or if the cough persists beyond seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition.

This product should be stored out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients may experience a range of adverse reactions while using this product. It is important for patients to stop use and consult a healthcare professional if they experience symptoms such as 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 should seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients 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.

Furthermore, patients are advised against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past 2 weeks. It is crucial for patients to verify with a healthcare professional or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while on MAOIs or within two weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. If patients are uncertain whether their prescription includes an MAOI, they are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Additionally, it is recommended that patients seek guidance from a healthcare provider before using this product in conjunction with any other oral nasal decongestants or stimulants. This precaution is essential to avoid potential adverse interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Robitussin Peak Cold Multi-Symptom Cold (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). 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. For patients aged 12 years and older, the recommended dosage is 10 ml every 4 hours. There are no established safety or efficacy profiles for children under 12 years, and therefore, use in this population is contraindicated.

Geriatric Use

Elderly patients should exercise caution when using this product, particularly those aged 65 and older. It is important for geriatric patients to consult with a healthcare provider prior to use, especially if they have pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties related to an enlarged prostate gland.

Due to the potential for altered pharmacokinetics and increased sensitivity to medications in this population, careful monitoring is recommended. Dosage adjustments may be necessary based on individual health status and response to treatment. The safety and efficacy of this product in geriatric patients have not been specifically established, and therefore, healthcare providers should consider these factors when prescribing to elderly individuals.

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 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 the use of 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 available 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure the best possible outcomes for affected individuals.

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 available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, rash, and persistent headache. Such reactions may occur in patients using the product.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. 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.

Patients should be advised to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be instructed to stop use and seek medical advice if their symptoms do not improve within seven days or if they are accompanied by fever. Patients should also be informed that if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, they should stop use and consult a doctor, as these may indicate a serious condition.

When using this product, patients should be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, 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. Furthermore, patients should be instructed to consult a doctor or pharmacist before use if they are taking any other oral nasal decongestant or stimulant.

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 20-25°C (68-77°F). 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 10 ml every 4 hours for adults and children aged 12 years and older. Patients should not exceed 6 doses within a 24-hour period to avoid potential overdose. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Robitussin Peak Cold Multi-Symptom Cold, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)