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Bliss Gvs Hemorrhoidal

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Active ingredient
Phenylephrine Hydrochloride 6.25 mg
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 2023
Label revision date
December 21, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 6.25 mg
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 2023
Label revision date
December 21, 2024
Manufacturer
Bliss GVS Pharma Limited
Registration number
M015
NDC root
72701-111
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

HEMORRHOIDAL SUPPOSITORIES are a type of medication designed to provide relief from the discomfort associated with hemorrhoids. They work by temporarily shrinking hemorrhoidal tissue and reducing swelling, which helps alleviate local itching and discomfort. These suppositories can also offer nighttime relief, making them a convenient option for managing symptoms related to hemorrhoids and other anorectal disorders.

Each package contains 12 suppositories, allowing for multiple applications to help prevent further irritation and provide prompt relief. If you're experiencing discomfort from hemorrhoids, these suppositories may be a helpful solution to consider.

Uses

If you're dealing with hemorrhoids, this medication can help relieve the local itching and discomfort you may be experiencing. It works by temporarily shrinking the hemorrhoidal tissue, providing you with some much-needed relief. Additionally, it can help reduce swelling associated with irritation in hemorrhoids and other anorectal disorders, making your day-to-day activities more comfortable.

Dosage and Administration

To use the suppository effectively, start by gently cleaning the area where you will insert it. You can do this by patting or blotting the area with a suitable cleansing wipe. After cleaning, make sure to dry the area by patting it with a tissue or a soft cloth.

Next, take one suppository from the strip and carefully separate the two tabs of the white plastic wrap. Grasp the tabs with your thumb and forefinger, and peel them downward to unwrap the suppository. Once unwrapped, you can insert the suppository into the rectum. For adults and children aged 12 and over, you can use one suppository up to four times a day, particularly at night, in the morning, or after each bowel movement. If the patient is under 12 years old, it’s important to consult a doctor before use.

What to Avoid

It's important to follow the recommended daily dosage of this medication. You should not exceed this dosage unless your doctor specifically instructs you to do so. This helps ensure your safety and the effectiveness of the treatment. Always consult with your healthcare provider if you have any questions or concerns about your medication.

Side Effects

You should be aware that this medication is intended for rectal use only. If you experience any bleeding or if your condition worsens or does not improve within 7 days, it’s important to stop using the product and consult a doctor.

Before using 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, please consult your doctor or pharmacist before use.

Warnings and Precautions

This product is intended for rectal use only. Before using it, you should consult 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 important to check with your doctor or pharmacist first. Always follow the recommended dosage and do not exceed it unless directed by your healthcare provider.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately. You should stop using the product and call your doctor if you experience any bleeding or if your condition worsens or does not improve within 7 days.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to get help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 your child is under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is to insert one suppository into the rectum up to four times a day. This can be done especially at night, in the morning, or after each bowel movement. Always follow your healthcare provider's guidance to ensure safe and effective use.

Geriatric Use

While there is no specific information about the use of Bliss GVS Hemorrhoidal (Phenylephrine HCl Suppository) in older adults, it’s important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health status and any other medications you may be taking.

Always prioritize open communication with your doctor or pharmacist, especially if you have any underlying health conditions or are experiencing changes in your health. This ensures that you receive the safest and most effective care tailored to your needs.

Renal Impairment

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

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

Hepatic Impairment

If you have liver problems, it's important to know that the 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 may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You will use this medication rectally, which means you will insert a suppository into your rectum. For adults and children aged 12 and older, you can use one suppository up to four times a day, particularly at night, in the morning, or after each bowel movement. If the patient is under 12 years old, it's important to consult a doctor for guidance on use.

FAQ

What is HEMORRHOIDAL SUPPOSITORIES used for?

HEMORRHOIDAL SUPPOSITORIES are used to prevent further irritation, reduce internal hemorrhoidal swelling, and provide prompt relief from itching and discomfort.

How do HEMORRHOIDAL SUPPOSITORIES work?

They help relieve local itching and discomfort, temporarily shrink hemorrhoidal tissue, and reduce swelling associated with irritation in hemorrhoids and other anorectal disorders.

How should I use HEMORRHOIDAL SUPPOSITORIES?

For adults and children 12 years and over, insert one suppository into the rectum up to 4 times daily, especially at night, in the morning, or after each bowel movement.

What should I do if I experience side effects?

Stop use and ask a doctor if bleeding occurs or if your condition worsens or does not improve within 7 days.

Are there any precautions I should take before using HEMORRHOIDAL SUPPOSITORIES?

Yes, ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement.

Can I use HEMORRHOIDAL SUPPOSITORIES if I am pregnant or breastfeeding?

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

What should I do if I accidentally swallow a suppository?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

How should I store HEMORRHOIDAL SUPPOSITORIES?

Store at 20-25°C (68-77°F).

Packaging Info

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

Packaging configurations for Bliss Gvs Hemorrhoidal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

HEMORRHOIDAL SUPPOSITORIES are formulated to prevent further irritation and reduce internal hemorrhoidal swelling. They provide prompt relief from itching and discomfort, including nighttime relief. Each package contains 12 suppositories. The product is manufactured and marketed by Bliss GVS Pharma Ltd., located at 102, Hyde Park, Saki Vihar Road, Andheri (E), Mumbai-400 072, India. The National Drug Code (NDC) for this product is 72701-111-12. For further information, contact via email at info@blissgvs.com or visit www.blissgvs.com.

Uses and Indications

This drug is indicated for the relief of local itching and discomfort associated with hemorrhoids. It temporarily shrinks hemorrhoidal tissue and reduces swelling associated with irritation in hemorrhoids and other anorectal disorders.

Limitations of Use: This product is intended for temporary relief and should not be used as a long-term treatment for hemorrhoids or anorectal disorders.

Dosage and Administration

When practical, the affected area should be cleansed by patting or blotting with an appropriate cleansing wipe. Following this, the area must be gently dried by patting or blotting with a tissue or a soft cloth prior to the insertion of the suppository.

To prepare the suppository for administration, detach one suppository from the strip. Carefully separate the two tabs of the white plastic wrap. Using the thumb and forefinger of each hand, grasp the tabs and peel downward to unwrap the suppository.

For adults and children aged 12 years and over, the recommended dosage is to insert one suppository into the rectum up to four times daily. This can be done especially at night, in the morning, or after each bowel movement.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended daily dosage unless directed by a healthcare professional. There are no additional contraindications specified in the available data.

Warnings and Precautions

For rectal use only.

Healthcare professionals should advise patients to consult a physician prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate gland enlargement. Additionally, patients currently taking prescription medications for high blood pressure or depression should seek guidance from a healthcare provider or pharmacist before using this product.

It is imperative that patients adhere to the recommended daily dosage and not exceed it unless directed by a physician.

In the event of accidental ingestion, it is crucial to keep this product out of reach of children. If swallowed, patients should seek immediate medical assistance or contact a Poison Control Center.

Patients should discontinue use and consult a healthcare professional if they experience any bleeding or if their condition worsens or fails to improve within 7 days.

Side Effects

Patients using this product should be aware of the following adverse reactions and safety information.

For rectal use only. Patients are advised to stop use and consult a doctor if bleeding occurs or if the condition worsens or does not improve within 7 days of use.

Before using this product, patients should seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland. Additionally, it is recommended that patients consult a doctor or pharmacist if they are currently taking a prescription medication for high blood pressure or depression.

These precautions are essential to ensure the safe and effective use of the product.

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 blood pressure or mood stabilization. Monitoring may be necessary to ensure safe and effective use of the medication in conjunction with these drug classes.

Packaging & NDC

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

Packaging configurations for Bliss Gvs Hemorrhoidal.
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 one suppository inserted into the rectum up to four times daily, particularly at night, in the morning, or following each bowel movement.

Geriatric Use

There is no specific information regarding the use of Bliss GVS Hemorrhoidal (Phenylephrine HCl Suppository) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data on its use in this population. Monitoring for efficacy and potential adverse effects is advisable in elderly patients receiving this treatment.

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 mothers.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert for Bliss GVS Hemorrhoidal - Phenylephrine HCl Suppository.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if any bleeding occurs. Additionally, they should be advised to discontinue use and seek medical advice if their condition worsens or does not improve within 7 days.

It is important to emphasize that patients should not exceed the recommended daily dosage unless directed by a healthcare professional. Providers should encourage patients to consult a doctor before using this product if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should be advised to speak with their doctor or pharmacist before using this product if they are currently taking a prescription medication for high blood pressure or depression.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

The route of administration for the medication is rectal. For adults and children aged 12 years and older, the recommended dosage is to insert one suppository into the rectum up to four times daily, particularly at night, in the morning, or after each bowel movement. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Bliss Gvs 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 Bliss Gvs 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.