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Uline Sinus and Congestion

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Active ingredient
Phenylephrine Hydrochloride 5 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
November 13, 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, Film Coated
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 2019
Label revision date
November 13, 2024
Manufacturer
Uline
Registration number
M012
NDC root
69790-161
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

ULINE is a nasal decongestant that contains phenylephrine HCl (a medication that helps relieve nasal congestion). It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as to alleviate sinus congestion and pressure.

When you use ULINE, you can expect relief from the discomfort of nasal and sinus congestion, helping you breathe more easily during times of illness or allergy flare-ups.

Uses

You can use this medication to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. If you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms. It's designed to provide you with some comfort when dealing with these common issues.

Dosage and Administration

When you need to take this medication, adults and children aged 12 years and older should take 2 tablets by mouth every 4 to 6 hours. It's important not to exceed 12 tablets in a 24-hour period to ensure your safety. If the person needing the medication is under 12 years old, you should consult a doctor for the appropriate dosage.

Make sure to take the tablets orally, which means swallowing them with water. Following these guidelines will help you use the medication effectively while minimizing the risk of side effects. Always remember to keep track of how many tablets you've taken to avoid going over the recommended limit.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric, or emotional conditions, or Parkinson's disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

It's also important to follow the recommended dosage and not exceed it. Misusing or abusing this product can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

If you experience nervousness, dizziness, or sleeplessness while using this medication, it's important to stop taking it and consult your doctor. Additionally, if your symptoms do not improve within 7 days or are accompanied by a fever, seek medical advice.

Before using this medication, make sure to talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Warnings and Precautions

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Before using this product, make sure you are not currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist.

You should stop taking this medication and contact your doctor if you experience nervousness, dizziness, or sleeplessness. Additionally, if your symptoms do not improve within 7 days or are accompanied by a fever, it's important to seek medical advice.

Overdose

Taking too much of a medication can lead to serious health issues. If you suspect an overdose, it’s crucial to seek medical attention right away. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you typically experience with the medication.

If you or someone else is experiencing an overdose, don’t wait—contact emergency services or go to the nearest hospital. Your health and safety are the top priority, so getting help quickly is essential.

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 have a child under 12 years old, it's important to consult with a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 2 tablets every 4 to 6 hours, but be sure not to exceed 12 tablets in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of this medication. Your doctor will determine the right dosage based on your creatinine clearance levels, which is a test that measures how well your kidneys are filtering waste from your blood.

To ensure your kidneys remain healthy while taking this medication, regular renal function tests are recommended. If you have severe renal impairment, special monitoring is essential to prevent any potential toxicity from the medication. Always discuss your kidney health with your healthcare provider to ensure safe and effective treatment.

Hepatic Impairment

If you have liver problems, it's important to know that your condition can affect how your body processes certain medications. This means that the dosage of the drug you are prescribed may need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) regularly while you are on this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver health.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease, you should not use 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 guidance.

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

Storage and Handling

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

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its safe use.

Additional Information

No further information is available.

FAQ

What is ULINE used for?

ULINE is used to temporarily relieve nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

What is the active ingredient in ULINE?

The active ingredient in ULINE is Phenylephrine HCl, which is a nasal decongestant.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and older should take 2 tablets every 4 to 6 hours, not exceeding 12 tablets in 24 hours.

What should I do if I am taking a monoamine oxidase inhibitor (MAOI)?

Do not use ULINE if you are currently taking a prescription MAOI or for 2 weeks after stopping the MAOI. Consult a doctor or pharmacist if unsure.

What precautions should I take if I have certain health conditions?

Before using ULINE, ask a doctor if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

What should I do if I experience side effects?

Stop using ULINE 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.

How should ULINE be stored?

Store ULINE at room temperature between 59º-86º F (15º-30º C) and keep it in tamper evident sealed packets. Do not use any opened or torn packets.

Is ULINE safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using ULINE.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Uline Sinus and Congestion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ULINE is a nasal decongestant formulation indicated for the relief of sinus and congestion symptoms. Each packet contains 5 mg of Phenylephrine HCl, an active ingredient known for its decongestant properties. The product is packaged in tamper-evident sealed packets, with a total of 50 packets, each containing 2 tablets. Users are advised not to use the product if the packet is open or torn. The packaging features a "Pull to Open" mechanism for ease of access.

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 advised to take 2 tablets orally every 4 to 6 hours as needed. The maximum allowable dosage is 12 tablets within a 24-hour period.

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

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 uncertain about whether their prescription includes an MAOI should consult a healthcare professional prior to using this product.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. 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.

Patients should exercise caution and refrain from using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for at least two weeks following the cessation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional, such as a doctor or pharmacist, is strongly advised.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, patients should also stop using the product and consult their doctor for further evaluation.

In cases of overdose, it is critical to obtain emergency medical help or contact the Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients should be advised to stop use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.

It is important for patients to ask 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. These considerations are crucial to ensure the safe use of the medication and to mitigate potential 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, certain psychiatric conditions, or 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, 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 Uline Sinus and Congestion (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Uline Sinus and Congestion.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours, with a maximum of 12 tablets in a 24-hour period. Caution is advised when administering to younger children, and healthcare providers should be consulted to ensure appropriate use and dosing.

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 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 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 the safety of both the mother and the developing fetus.

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 individuals.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure appropriate therapeutic outcomes while minimizing the risk of adverse effects. Regular renal function tests are recommended to monitor kidney health in patients receiving this medication. Additionally, special monitoring is necessary for patients with severe renal impairment to avoid potential toxicity.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in this population to assess the degree of impairment and guide treatment decisions. Special precautions should be taken when administering the drug to patients with compromised liver function, as their response to therapy may differ from that of patients with normal liver function. Regular evaluation of liver parameters is recommended to mitigate potential risks associated with treatment in these patients.

Overdosage

Overdosage may lead to serious adverse effects that can significantly impact patient health. It is imperative that healthcare professionals recognize the potential severity of an overdose and act promptly.

In the event of an overdose, immediate medical attention is essential. Healthcare providers should ensure that patients or caregivers are advised to seek emergency medical assistance without delay.

Management of an overdose will depend on the specific substance involved and the symptoms presented. Continuous monitoring and supportive care may be required to address any complications that arise. It is crucial for healthcare professionals to follow established protocols for overdose management, which may include symptomatic treatment and, if applicable, the use of antidotes.

Prompt recognition and intervention are key to mitigating the risks associated with overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last 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 counsel patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, patients 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 a fever.

It is important to remind patients not to exceed the recommended dosage while using this product. Providers should also recommend that patients consult a doctor before use 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.

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 59º to 86º F (15º to 30º 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. Proper handling and storage conditions are crucial to maintain the product's intended use and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Uline Sinus and Congestion, 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 Uline Sinus and Congestion, 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.