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Actifed

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Active ingredient
Phenylephrine Hydrochloride 5 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 4, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 5 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 4, 2024
Manufacturer
Belmora LLC
Registration number
M012
NDC root
27854-119
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

ACTIFED-119 is a medication designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. It can also help alleviate sinus congestion and pressure, making it easier for you to breathe comfortably when you're feeling under the weather.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms. It's designed to make you feel more comfortable when you're dealing with these common respiratory issues.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 tablets every 4 to 6 hours as needed. However, make sure not to exceed 12 tablets in a 24-hour period to avoid potential side effects.

For children under 12 years old, it’s important to consult a doctor before giving them this medication. Always follow their guidance to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. Avoid using it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. It's crucial not to exceed the recommended dosage. Before using this product, consult your doctor if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate.

If you experience nervousness, dizziness, or sleeplessness, stop using the product and consult your doctor. Additionally, if your symptoms do not improve within seven days or are accompanied by a fever, seek medical advice. If you are pregnant or breastfeeding, it's best to talk to a healthcare professional before use. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson's disease, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist. Always follow the recommended dosage and consult a doctor before using this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate.

If you experience nervousness, dizziness, or sleeplessness, stop using the product and contact your doctor. Additionally, if your symptoms do not improve within seven days or are accompanied by a fever, you should also seek medical advice. In case of an overdose, it is crucial to get emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering using this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. This ensures that the treatment is safe and appropriate for their specific age and health needs. Always prioritize your child's well-being by seeking professional advice when it comes to their medication.

Geriatric Use

While there is no specific information about the use of ACTIFED (phenylephrine hydrochloride) in older adults, it's important to approach any medication with caution. As you age, your body may process medications differently, and you might have unique health considerations. Always consult with your healthcare provider before starting any new medication to ensure it’s safe and appropriate for your individual health needs.

If you or a loved one is an older adult, be sure to discuss any existing health conditions or medications you are taking, as these factors can influence how well ACTIFED works and whether it’s suitable for you. Your healthcare provider can help determine the best course of action.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's crucial to be aware of potential interactions when taking any medication. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's disease, you should not take this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid harmful interactions. Your health is important, and your provider can help you make informed decisions about your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). It's important to keep the product in its tamper-evident sealed packets until you are ready to use it. If you notice that any packets are opened or torn, do not use them, as this could compromise the product's integrity and safety.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure a safe experience.

Additional Information

You should take this medication orally, with a recommended dosage of 2 tablets every 4 to 6 hours. However, be careful not to exceed 12 tablets in a 24-hour period to avoid potential risks. If you have any questions about your treatment or how to take this medication, consult your healthcare provider for guidance.

FAQ

What is ACTIFED-119 used for?

ACTIFED-119 temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

What is the recommended dosage for adults and children 12 years and older?

You should take 2 tablets every 4-6 hours, but do not exceed 12 tablets in 24 hours.

What should I do if I am under 12 years old?

If you are under 12 years old, you should ask a doctor before using ACTIFED-119.

Are there any warnings I should be aware of?

Do not use ACTIFED-119 if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate.

What should I do if I experience side effects?

Stop using ACTIFED-119 and ask a doctor if you feel nervous, dizzy, or sleepless, or if symptoms do not improve within 7 days or are accompanied by fever.

Is it safe to use ACTIFED-119 during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using ACTIFED-119.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store ACTIFED-119?

Store ACTIFED-119 at room temperature between 59°-86° F (15°-30° C) and do not use any opened or torn packets.

Packaging Info

Below are the non-prescription pack sizes of Actifed (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Actifed.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ACTIFED-119 is a pharmaceutical formulation characterized by its specific chemical composition and intended therapeutic use. The product is presented in a dosage form suitable for administration, ensuring optimal delivery of its active ingredients. The molecular weight and chemical formula are integral to its pharmacological profile, contributing to its efficacy and safety in clinical applications. The formulation is designed to meet rigorous standards for quality and consistency, ensuring that each unit meets the specified criteria for appearance and performance.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 tablets every 4 to 6 hours as needed. The total dosage should not exceed 12 tablets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

It is imperative that patients adhere to the recommended dosage and not exceed it. Prior to using this product, individuals with a history of heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should seek medical advice.

Patients are instructed to discontinue use and consult a healthcare provider if they experience symptoms such as nervousness, dizziness, or insomnia. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, medical consultation is necessary.

For pregnant or breastfeeding individuals, it is essential to seek guidance from a healthcare professional before using this product.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Patients should also stop taking the product and contact their doctor if they experience nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within seven days or are accompanied by fever.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with specific pre-existing conditions. It is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing urinary difficulties due to an enlarged prostate gland should consult a healthcare professional before use.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and seek medical advice if these symptoms occur or if symptoms do not improve within seven days, especially if accompanied by fever.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. It is also recommended that pregnant or breastfeeding individuals consult a healthcare professional prior to use. Adherence to the recommended dosage is crucial to minimize the risk of adverse reactions.

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 disorders, emotional conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Actifed (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Actifed.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for ACTIFED (phenylephrine hydrochloride). Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, particularly those aged 65 and older.

Due to the lack of detailed information regarding geriatric use, it is advisable for healthcare providers to closely monitor elderly patients for any adverse effects or changes in response to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of ACTIFED 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 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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 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. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop during the course of treatment.

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 keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at room temperature, specifically within the range of 59° to 86° F (15° to 30° C). Healthcare professionals are advised to refrain from using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 2 tablets every 4 to 6 hours. Patients should not exceed a total of 12 tablets within a 24-hour period.

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 Actifed, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Actifed, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.