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Phenylephrine Hemorrhoidal

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Active ingredient
Phenylephrine Hydrochloride 5 mg/2 g
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Suppository
Route
Rectal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
June 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 5 mg/2 g
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Suppository
Route
Rectal
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 2025
Label revision date
June 20, 2025
Manufacturer
Neilmed Pharmaceuticals Inc.
Registration number
M015
NDC root
13709-330
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 is a medication designed to help relieve the local itching and discomfort associated with hemorrhoids. It works by temporarily relieving burning sensations and shrinking hemorrhoidal tissue, providing a protective coating that alleviates anorectal discomfort. This can make bowel movements less painful by protecting the inflamed and irritated areas in the anorectal region.

If you're experiencing discomfort from hemorrhoids, phenylephrine can offer temporary relief by soothing irritation and helping to reduce swelling. It's important to use it as directed to ensure you get the best results.

Uses

If you're dealing with hemorrhoids, this medication can help ease your discomfort. It works by relieving local itching and discomfort associated with hemorrhoids, making your day-to-day activities more manageable.

In addition to alleviating itching, it temporarily relieves burning sensations and helps shrink hemorrhoidal tissue. This medication also provides a protective coating that can soothe anorectal discomforts, making bowel movements less painful. With these benefits, you can find some relief from the irritation and discomfort that hemorrhoids can cause.

Dosage and Administration

To use this medication effectively, start by gently cleaning the affected area. You can do this by patting or blotting with a suitable cleansing wipe. After that, make sure to dry the area by patting or blotting with a tissue or a soft cloth before you proceed with the medication.

Next, take one suppository from the strip and carefully remove the foil wrapper. To use it, insert the suppository into the rectum with the pointed end facing inwards. You can do this up to four times a day, particularly at night, in the morning, or after each bowel movement. Following these steps will help ensure the medication works as intended.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should never exceed the recommended daily dosage unless your doctor specifically instructs you to do so. If you are considering this medication for a child under 12 years of age, please consult a doctor first to ensure it is appropriate.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always prioritize following the guidelines provided by your healthcare professional. Your health and safety are paramount, so don't hesitate to reach out to your doctor with any questions or concerns.

Side Effects

When using this medication, it's important to remember that it is for rectal use only. You should stop using it and consult your doctor if you experience any bleeding or if your condition worsens or does not improve within 7 days.

Before starting this medication, 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. Additionally, if you are currently taking prescription medications for high blood pressure or depression, it's advisable to consult with your doctor or pharmacist before use.

Warnings and Precautions

This medication is intended for rectal use only. If you accidentally swallow it, please seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this medication and call your doctor if you experience any bleeding or if your condition worsens or does not improve within 7 days. It's important to monitor your symptoms closely and take action if necessary.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, as this will help them provide the best care. Remember, it's always better to be safe and get checked out if you have any concerns.

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 this medication for your child, it's important to know that it is not recommended for children under 12 years of age without consulting a doctor first. Always reach out to your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their needs.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe for your liver health. They can help determine the best approach for your treatment based on your individual circumstances.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs for high blood pressure or depression. These medications can interact in ways that may affect how well they work or increase the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking to ensure your safety and the best possible treatment outcomes.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° and 25°C (68° and 77°F). It's important to keep it away from extreme heat or cold, as this can affect its effectiveness.

When handling the product, always check the lot number and expiration date, which you can find on the wrapper or box. This will help you confirm that you are using a safe and effective item. If you have any questions about disposal or further safety measures, please consult the product guidelines or your healthcare provider.

Additional Information

No further information is available.

FAQ

What is Phenylephrine used for?

Phenylephrine helps relieve local itching and discomfort associated with hemorrhoids, temporarily relieves burning, shrinks hemorrhoidal tissue, and protects the inflamed anorectal surface.

How should I use Phenylephrine?

For adults, cleanse the affected area, gently dry it, and insert one suppository pointed end first into the rectum up to 4 times daily, especially at night, in the morning, or after each bowel movement.

Are there any warnings for using Phenylephrine?

Yes, it is for rectal use only. Do not exceed the recommended dosage unless directed by a doctor, and consult a doctor if you have certain health conditions or if bleeding occurs.

What should I do if I experience bleeding while using Phenylephrine?

If bleeding occurs or if your condition worsens or does not improve within 7 days, stop using the product and ask your doctor.

Can children use Phenylephrine?

Children under 12 years of age should ask a doctor before use.

What should I do if I accidentally swallow Phenylephrine?

If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

What are the storage instructions for Phenylephrine?

Store Phenylephrine at 20° - 25°C (68° - 77°F).

Should I consult a doctor before using Phenylephrine if I am pregnant or breastfeeding?

Yes, if you are pregnant or breastfeeding, you should ask a health professional before use.

Packaging Info

Below are the non-prescription pack sizes of Phenylephrine Hemorrhoidal (hemorrhoidal suppositories). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Phenylephrine Hemorrhoidal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Phenylephrine is presented in a dosage form of suppositories, with each unit containing phenylephrine as the active ingredient. The product is available in a package containing 15 suppositories.

Uses and Indications

This drug is indicated for the relief of local itching and discomfort associated with hemorrhoids. It temporarily alleviates burning sensations and reduces the size of hemorrhoidal tissue. Additionally, it provides a protective coating that offers relief from anorectal discomforts and helps to minimize pain during bowel movements by protecting the inflamed and irritated anorectal surface.

Dosage and Administration

Adults should cleanse the affected area when practical by patting or blotting with an appropriate cleansing wipe. The area should then be gently dried by patting or blotting with a tissue or a soft cloth prior to the insertion of the product.

To administer, detach one suppository from the strip and remove the foil wrapper as indicated in the accompanying illustration. Insert one suppository into the rectum, pointed end first. This may be done up to four times daily, with particular emphasis on administration at night, in the morning, or following each bowel movement.

Contraindications

Use is contraindicated in patients who exceed the recommended daily dosage unless directed by a healthcare professional. Additionally, the use of this product is not recommended for children under 12 years of age without consulting a doctor.

Warnings and Precautions

For rectal use only. It is imperative that healthcare professionals ensure patients are aware of this specific route of administration to prevent misuse.

In the event of accidental ingestion, immediate medical assistance is required. Patients should be instructed to contact a Poison Control Center or seek medical help without delay by calling 1-800-222-1222.

Healthcare providers should advise patients to discontinue use and consult a physician if any of the following occur: bleeding or if the patient's condition worsens or fails to improve within 7 days of treatment. These symptoms may indicate a need for further evaluation and intervention.

There are no specific laboratory tests recommended for monitoring during the use of this medication. However, healthcare professionals should remain vigilant for any adverse effects or complications that may arise during treatment.

Side Effects

Patients should be aware that the product is intended for rectal use only. It is important to stop use and consult a healthcare professional if bleeding occurs or if the condition worsens or does not improve within 7 days of use.

Before using this product, patients with certain medical conditions should seek advice from a doctor. These conditions include heart disease, high blood pressure, thyroid disease, diabetes, and difficulty in urination due to enlargement of the prostate gland. Additionally, patients who are currently taking prescription medications for high blood pressure or depression should consult a doctor or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are currently prescribed any antihypertensive agents or antidepressants. This precaution is essential to evaluate potential interactions that may affect the efficacy of either treatment or increase the risk of adverse effects.

Monitoring of blood pressure and mental health status may be warranted in patients receiving concurrent therapy with these drug classes to ensure safe and effective use. Adjustments to dosages of either medication may be necessary based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Phenylephrine Hemorrhoidal (hemorrhoidal suppositories). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Phenylephrine Hemorrhoidal.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information available 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific details regarding overdosage for this medication (SPL code 34088-5), it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdosage.

Healthcare providers should be aware that the clinical presentation of overdosage may vary depending on the specific medication involved. Common symptoms may include, but are not limited to, gastrointestinal disturbances, central nervous system effects, and cardiovascular abnormalities.

In the event of an overdosage, it is recommended that healthcare professionals take the following actions:

  1. Assessment: Conduct a thorough assessment of the patient, including a detailed history of the substance ingested, the amount, and the time of ingestion.

  2. Supportive Care: Initiate supportive care as necessary, which may include monitoring vital signs, providing oxygen, and ensuring intravenous access for fluid administration if indicated.

  3. Symptomatic Treatment: Manage symptoms as they arise, which may involve the use of specific antidotes if available and appropriate for the substance involved.

  4. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on the management of the specific overdosage scenario.

  5. Documentation: Document all findings, interventions, and the patient's response to treatment thoroughly.

It is crucial for healthcare professionals to remain informed about the specific characteristics and potential risks associated with the medications they prescribe, including the implications of overdosage.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. Patients should be instructed to discontinue use and consult a doctor if any bleeding occurs. Additionally, they should be informed to stop using the product and seek medical advice if their condition worsens or does not improve within 7 days.

When discussing the use of this product, healthcare providers should emphasize the importance of adhering to the recommended daily dosage and caution against exceeding it unless directed by a physician. It is essential to inform patients that children under 12 years of age should consult a doctor before using the product.

Providers should also encourage patients to consult a doctor prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to an enlarged prostate gland. Furthermore, patients should be advised to speak with their doctor or pharmacist if they are currently taking a prescription medication for high blood pressure or depression.

Storage and Handling

The product is supplied in packaging that includes specific lot numbers and expiration dates, which can be found on the wrapper or box. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to ensure its stability and efficacy. Proper handling and storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Phenylephrine Hemorrhoidal, 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 Phenylephrine Hemorrhoidal, 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.

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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.