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Proctozone-G

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Active ingredient
Glycerin 1.2 g
Other brand names
Drug class
Non-Standardized Chemical Allergen
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
January 6, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Glycerin 1.2 g
Other brand names
Drug class
Non-Standardized Chemical Allergen
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
January 6, 2026
Manufacturer
Rising Pharma Holdings, Inc.
Registration number
M007.54
NDC root
57237-338
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

Proctozone-G is a type of rectal laxative that comes in the form of glycerin suppositories, each weighing 1.2 grams. It is primarily used to provide relief from occasional constipation, helping to stimulate a bowel movement typically within 15 minutes to 1 hour after use.

If you're experiencing difficulty with bowel movements, Proctozone-G may be a helpful option to consider for quick relief.

Uses

If you're experiencing occasional constipation, this product can help provide relief. It typically works quickly, usually producing a bowel movement within 15 minutes to 1 hour after taking it.

You can feel confident using this product, as there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refer to other types of harmful effects).

Dosage and Administration

To use the suppository, start by tearing one from the strip. If it feels soft, you can place it in the refrigerator for a bit or run cold water over it before taking it out of the foil wrapper. Carefully peel apart the wrapper to remove the suppository. To make insertion easier, you can rub a water-based lubricant on the tip or dip it in water.

When you're ready, lie on your side and gently insert the suppository, tapered end first, into the rectum about the length of your finger. It's important to hold the suppository in place for about 15 to 20 minutes to give it time to melt properly. For children aged 2 to under 6 years, the recommended dose is one suppository once a day. If your child is under 2 years old, be sure to consult a doctor before use.

What to Avoid

It's important to use this medication responsibly. You should not take it for longer than one week unless your doctor specifically instructs you to do so. This guideline helps prevent potential issues related to prolonged use. Always follow your healthcare provider's advice to ensure your safety and well-being. If you have any questions or concerns about your treatment, don't hesitate to reach out to your doctor.

Side Effects

When using this product, your child may experience some rectal discomfort or a burning sensation. It's important to monitor for more serious issues; if you notice rectal bleeding or if your child does not have a bowel movement after using the product, you should stop use and consult a doctor, as these could indicate a serious condition.

Before using this product, consult a doctor if your child has stomach pain, nausea, or vomiting, or if there has been a sudden change in bowel habits lasting more than two weeks.

Warnings and Precautions

This product is intended for rectal use only. It’s important not to use it for more than one week unless your doctor advises you to do so. If your child experiences stomach pain, nausea, vomiting, or a sudden change in bowel habits lasting more than two weeks, consult a doctor before using this product.

If the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately. Additionally, you should stop using the product and call your doctor if you notice rectal bleeding or if there is no bowel movement after using it, as these could be signs of a serious condition.

Overdose

If you or someone else has swallowed too much of a 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. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or precautions regarding the use of Proctozone-G glycerin suppositories during this time. This means that, based on the available information, these suppositories are not expected to pose a risk to you or your developing baby. However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for your individual situation.

Lactation Use

If you are breastfeeding, you can use Proctozone-G glycerin suppositories without specific warnings or recommendations against their use. Currently, there is no information available about whether these suppositories pass into breast milk or if they pose any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

Pediatric Use

If your child is between 2 and 6 years old, you can give them one suppository once a day. For children under 2 years old, it's important to consult a doctor before use. Always check with a doctor if your child experiences stomach pain, nausea, or vomiting, or if there is a sudden change in their bowel habits that lasts more than two weeks.

While using this product, your child might feel some rectal discomfort or a burning sensation. If you notice any rectal bleeding or if your child does not have a bowel movement after using the product, stop use immediately and consult a doctor, as these could be signs of a more serious issue.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can provide guidance based on your individual needs and kidney function.

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).

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 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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. 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, it's important to store it in a cool, dry place, away from excessive heat. High temperatures can damage the product and affect its performance.

When handling the product, always do so with care to maintain its integrity. If you have any specific components that come with the product, make sure to follow any additional instructions provided for their use and safety. Proper storage and handling will help you get the best results from your product.

Additional Information

You will administer this medication rectally. For children aged 2 to under 6 years, the recommended dose is one suppository once daily. If your child is under 2 years old, you should consult a doctor for guidance on the appropriate dosage. Always follow your healthcare provider's instructions for safe and effective use.

FAQ

What is Proctozone-G used for?

Proctozone-G is used for the relief of occasional constipation.

How quickly does Proctozone-G work?

This product usually produces a bowel movement in 1/4 to 1 hour.

How should I use Proctozone-G?

Tear off one suppository, and if it seems soft, refrigerate it or run cold water over it before use. Insert it tapered end first into the rectum and hold it for about 15-20 minutes.

What is the recommended dosage for children?

For children aged 2 to under 6 years, use 1 suppository once daily. For children under 2 years, consult a doctor.

Are there any side effects associated with Proctozone-G?

Your child may experience rectal discomfort or a burning sensation. Stop use and consult a doctor if there is rectal bleeding or no bowel movement after use.

Is Proctozone-G safe to use during pregnancy?

There are no specific warnings or precautions mentioned regarding the use of Proctozone-G during pregnancy.

Can nursing mothers use Proctozone-G?

There are no specific warnings or recommendations regarding the use of Proctozone-G in nursing mothers.

What should I do if my child has stomach pain or a sudden change in bowel habits?

Ask a doctor before using Proctozone-G if your child has stomach pain, nausea, vomiting, or a sudden change in bowel habits lasting more than 2 weeks.

What should I do if Proctozone-G is swallowed?

If swallowed, get medical help or contact a Poison Control Center immediately.

How should Proctozone-G be stored?

Keep Proctozone-G away from excessive heat.

Packaging Info

Below are the non-prescription pack sizes of Proctozone-G (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proctozone-G.
Details

Drug Information (PDF)

This file contains official product information for Proctozone-G, 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 relief of occasional constipation. It typically produces a bowel movement within 15 minutes to 1 hour after administration.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

Tear off one suppository from the strip. If the suppository appears soft, it is recommended to place it in the refrigerator prior to use or run cold water over it before removing the foil wrapper. Gently remove the suppository by peeling apart the wrapper.

To facilitate insertion, healthcare professionals should advise patients to rub a water-based lubricant over the tip of the suppository or dip it in water. Patients should lie on their side and insert one suppository, tapered end first, approximately the length of their finger into the rectum. It is important to hold the suppository in place for about 15 to 20 minutes to allow sufficient time for it to melt.

For pediatric patients aged 2 to under 6 years, the recommended dosage is one suppository administered once daily. For children under 2 years of age, consultation with a physician is advised prior to administration.

Contraindications

Use is contraindicated for periods exceeding one week unless directed by a healthcare professional. Prolonged use may lead to potential complications or adverse effects that require medical oversight.

Warnings and Precautions

For rectal use only. This product is intended exclusively for administration via the rectal route, and any other method of use is not recommended.

It is advised that this product not be used for longer than one week unless specifically directed by a healthcare professional. Prior to use, it is essential to consult a physician if the child experiences any of the following conditions: stomach pain, nausea, or vomiting, or if there is a sudden change in bowel habits lasting more than two weeks.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: rectal bleeding or failure to have a bowel movement after using this product. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product may experience rectal discomfort or a burning sensation. These side effects are generally mild; however, it is important to monitor for more serious reactions.

Patients should discontinue use and consult a healthcare professional if they experience rectal bleeding or if there is no bowel movement after using the product, as these symptoms may indicate a serious underlying condition.

Additionally, it is advisable to seek medical advice before using this product if the child has a history of stomach pain, nausea, or vomiting, or if there is a sudden change in bowel habits lasting more than two weeks. Such conditions may warrant further evaluation prior to treatment.

This product is intended for rectal use only, and adherence to these guidelines is essential for ensuring patient safety.

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 Proctozone-G (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proctozone-G.
Details

Pediatric Use

Pediatric patients aged 2 to under 6 years may be administered 1 suppository once daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Healthcare professionals should instruct caregivers to seek medical advice before using this product if the child experiences stomach pain, nausea, or vomiting, or if there is a sudden change in bowel habits lasting more than 2 weeks.

While using this product, pediatric patients may experience rectal discomfort or a burning sensation. Caregivers should be advised to discontinue use and consult a doctor if rectal bleeding occurs or if there is no bowel movement after administration, as these symptoms may indicate a serious condition.

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.

Pregnancy

There are no specific warnings or precautions regarding the use of Proctozone-G glycerin suppositories during pregnancy. However, healthcare professionals should consider the potential risks and benefits when prescribing this medication to pregnant patients. It is advisable to monitor for any adverse effects and to counsel women of childbearing potential on the importance of discussing any medications with their healthcare provider during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Proctozone-G glycerin suppositories in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication 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 these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product for longer than one week unless directed by a healthcare professional. It is important to counsel patients to stop using the product and consult a doctor if they experience rectal bleeding or if there is no bowel movement after using the product, as these symptoms may indicate a serious condition.

When using this product, patients should be made aware that their child may experience rectal discomfort or a burning sensation. Additionally, healthcare providers should recommend that patients consult a doctor before use if the child has stomach pain, nausea, or vomiting, or if there is a sudden change in bowel habits lasting more than two weeks.

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 in a cool, dry place, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The route of administration for the medication is rectal. For children aged 2 to under 6 years, the recommended dosage is one suppository administered once daily. For children under 2 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 Proctozone-G, 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 Proctozone-G, 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.