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Crane Safety 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 2020
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 2020
Label revision date
September 8, 2025
Manufacturer
Crane Safety LLC
Registration number
M012
NDC root
73408-990
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

Phenylephrine HCl is a medication commonly used as a sinus and nasal decongestant. It works by temporarily relieving nasal congestion caused by conditions such as the common cold, hay fever, or other upper respiratory allergies. Additionally, it helps alleviate sinus congestion and pressure, making it easier for you to breathe comfortably.

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 suffering from these common issues.

Dosage and Administration

When taking this medication, adults and children aged 12 years and older should take 1 tablet every 4 hours. It's important not to exceed 6 tablets in a 24-hour period to avoid potential side effects. If you have a child under 12 years old, it's best to consult a doctor for the appropriate dosage.

Always remember to follow the directions provided and do not use more than what is recommended. This ensures you get the most benefit from the medication while minimizing any risks.

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 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 important to follow these guidelines to ensure your safety and well-being.

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

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

If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or are accompanied by a fever, stop using the product and contact your doctor. In the event of an overdose, seek emergency medical help immediately or call a Poison Control Center at 1-800-222-1222.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 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 the medication. Before starting treatment, your healthcare provider will assess your creatinine clearance (a test that measures how well your kidneys are filtering waste). Regular tests to monitor your kidney function are also recommended to ensure your safety while on this medication.

For those with significant renal impairment, special monitoring is necessary to prevent potential toxicity. Always communicate with your healthcare provider about your kidney health to ensure the best treatment plan for you.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your healthcare provider might change how much of the medication you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which check how well your liver is working) is recommended to keep an eye on your liver health while you are on this medication.

Always exercise caution when taking this medication if you have liver dysfunction. Make sure to discuss your liver condition with your healthcare provider, who can guide you on the best approach for your treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and receive the best care possible.

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 use the tamper-evident sealed packets provided, as these help guarantee that the product has not been compromised. If you notice any packets that are opened or torn, do not use them, as this could affect the safety and quality of the product. Always handle the packets with care to maintain their integrity.

Additional Information

No further information is available.

FAQ

What is Phenylephrine HCl used for?

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

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

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

Are there any contraindications for using Phenylephrine HCl?

Do not use Phenylephrine HCl if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the last 2 weeks.

What should I do if I experience side effects?

Stop using Phenylephrine HCl 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 Phenylephrine HCl during pregnancy or breastfeeding?

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

How should I store Phenylephrine HCl?

Store Phenylephrine HCl at room temperature between 59º-86º F (15º-30º C) and use tamper evident sealed packets.

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 Crane Safety Sinus Decongestant (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crane Safety Sinus Decongestant.
Details

Drug Information (PDF)

This file contains official product information for Crane Safety 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. 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 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.

It is imperative that patients do not exceed the directed dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. 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

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 cessation 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.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience symptoms such as nervousness, dizziness, or insomnia. Furthermore, if symptoms do not show improvement within seven days or are accompanied by fever, medical advice should be sought.

In the event of an overdose, immediate medical assistance is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, utilizing the contact number 1-800-222-1222 for guidance.

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

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Crane Safety 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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare 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 may necessitate a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering this medication to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment and Monitoring: Conduct a thorough evaluation of the patient's vital signs and mental status. Continuous monitoring may be necessary to detect any deterioration in the patient's condition.

  2. Supportive Care: Initiate supportive measures as needed, which may include airway management, oxygen supplementation, intravenous fluids, and medications to stabilize cardiovascular function.

  3. Decontamination: If the overdose is recent and the patient is alert and able to protect their airway, consider activated charcoal administration to limit further absorption of the substance.

  4. Specific Antidotes: If applicable, administer specific antidotes as indicated for the substance involved in the overdose. Familiarity with the appropriate antidotes and their administration protocols is essential.

  5. Consultation with Poison Control: Engage with a poison control center for expert guidance on the management of the overdose, including recommendations for further treatment and monitoring.

  6. Documentation and Reporting: Document all findings, interventions, and the patient's response to treatment thoroughly. Reporting the incident to relevant authorities may also be required, depending on local regulations.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to act swiftly and effectively in managing potential overdose situations, utilizing established protocols and resources to ensure optimal patient outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 instruct 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. Furthermore, healthcare providers should 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 safety and integrity. 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 avoid 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 Crane Safety 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 Crane Safety 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.