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Unishield Sinus Decongestant

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Active ingredient
Phenylephrine Hydrochloride 10 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 2021
Label revision date
September 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 10 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 2021
Label revision date
September 8, 2025
Manufacturer
Unishield
Registration number
M012
NDC root
49314-2083
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

Unishield is a sinus 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. Additionally, Unishield helps alleviate sinus congestion and pressure, making it useful for addressing sinus headaches, pain, and discomfort.

If you're experiencing symptoms related to nasal or sinus congestion, Unishield may provide the relief you need to feel more comfortable.

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 also works to ease sinus congestion and pressure, making it easier for you to breathe. Additionally, if you're experiencing a sinus headache along with pain and pressure, this medication can help alleviate those symptoms as well.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as needed. However, it's important not to exceed 6 tablets in a 24-hour period to ensure your safety.

For children under 12 years old, it's best to consult a doctor before giving them this medication. They can provide guidance on the appropriate dosage and ensure it's safe for your child's specific needs. Always follow these instructions carefully to use the medication effectively and safely.

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 and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice promptly.

Before starting this medication, you should 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. These factors may affect how the medication works for you.

Warnings and Precautions

It's important to be cautious when using this medication. Do not take it if you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain emotional conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your current medication includes an MAOI, please consult your doctor or pharmacist.

If you experience an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, you should stop using this medication and call your doctor if you feel nervous, dizzy, or unable to sleep, or if your symptoms do not improve within seven days or are accompanied by a fever.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, you should seek immediate medical attention. Contact your healthcare provider or go to the nearest emergency room right away. It's crucial to act quickly, as timely intervention can make a significant difference in your health outcomes. Always follow the prescribed dosage and consult your doctor if you have any questions or concerns about your medication.

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 one tablet every four hours, but be sure not to exceed six 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 for personalized advice. 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 your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your kidney function tests is essential to ensure your treatment remains safe and effective.

For those with severe renal impairment, special considerations are necessary, and your healthcare provider will guide you on the appropriate dosage and any additional precautions. Always communicate openly with your doctor about your kidney health to receive the best care possible.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This is because your liver may not process the drug in the same way as someone without liver issues. Additionally, your healthcare provider will likely recommend special monitoring of your liver function tests (which check how well your liver is working) to ensure your safety while using this medication.

Caution is advised when taking this drug if you have hepatic impairment, as your liver's ability to metabolize (break down) the medication could be affected. Always discuss your liver health with your doctor to ensure the best treatment plan for you.

Drug Interactions

It's important to be cautious when taking phenylephrine HCl, especially if you are on a prescription medication called a monoamine oxidase inhibitor (MAOI). Using phenylephrine while taking an MAOI or within two weeks of stopping it can cause a serious increase in blood pressure, known as severe hypertension.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. They can help you understand how different drugs may affect each other and your overall health.

Storage and Handling

To ensure the safety and effectiveness 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 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

No further information is available.

FAQ

What is Unishield?

Unishield is a sinus decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

What is the active ingredient in Unishield?

The active ingredient in Unishield is Phenylephrine HCl, which is present at a dosage of 10 mg per tablet.

How should adults and children 12 years and older take Unishield?

Adults and children 12 years and older should take 1 tablet every 4 hours, not exceeding 6 tablets in 24 hours.

What should children under 12 do before taking Unishield?

Children under 12 years should ask a doctor before taking Unishield.

Are there any contraindications for using Unishield?

You should not use Unishield if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience side effects while using Unishield?

Stop using Unishield 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.

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

Before using Unishield, consult 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 in case of an overdose?

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

Can I use Unishield if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Unishield.

How should Unishield be stored?

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

Packaging Info

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

Packaging configurations for Unishield Sinus Decongestant.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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. It also provides temporary relief from sinus congestion and pressure, as well as alleviating symptoms of sinus headache, pain, and congestion.

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 1 tablet every 4 hours as needed. The maximum allowable dosage is 6 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 use.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers are encouraged to contact a Poison Control Center at 1-800-222-1222 for guidance.

Patients should discontinue use and consult a healthcare provider if they experience symptoms such as nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, it is imperative to seek medical advice.

Side Effects

Patients should be advised to discontinue 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, medical advice should be sought.

It is important for patients to inform their healthcare provider prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may influence the safety and efficacy of the treatment.

Drug Interactions

The concomitant use of phenylephrine HCl with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Administration of phenylephrine HCl in patients currently taking an MAOI or within two weeks of discontinuing an MAOI may result in severe hypertension. It is essential to avoid this combination to prevent potentially serious cardiovascular effects.

No additional drug interactions or laboratory test interactions have been identified. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication noted above.

Packaging & NDC

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

Packaging configurations for Unishield Sinus Decongestant.
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 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. Caution is advised to ensure adherence to the dosing guidelines to prevent potential overdose.

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 potential adverse effects or changes in efficacy, 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests in these patients to ensure appropriate management. Specifically, patients with reduced creatinine clearance may require a reduced dose to avoid potential toxicity. Additionally, special considerations should be taken for patients with severe renal impairment to ensure their safety and the efficacy of treatment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to potential alterations in hepatic metabolism. It is recommended that liver function tests be monitored closely in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with compromised liver function, as their response to treatment may differ from that of patients with normal liver function.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication.

Should an overdose occur, it is crucial to monitor the patient closely for any adverse effects. Symptoms of overdose may vary depending on the specific medication involved and the individual patient's response.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers are advised to implement supportive measures and symptomatic treatment as necessary.

Additionally, contacting a poison control center or a medical toxicologist may provide valuable guidance on the management of overdose cases. It is important to document all relevant details of the incident, including the amount ingested, the time of ingestion, and any symptoms exhibited by the patient, to facilitate appropriate care.

Ongoing assessment and monitoring of the patient’s vital signs and overall clinical status are recommended until the effects of the overdose have resolved.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

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 that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Healthcare providers should encourage patients to consult with a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

Patients should be counseled to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, patients should seek medical advice.

It is essential to emphasize that patients should not exceed the recommended dosage while using this product. Healthcare 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, within the range of 59º to 86º F (15º to 30º C). Healthcare professionals are advised to avoid using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Unishield Sinus Decongestant, 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 Unishield Sinus Decongestant, 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.