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Glycerin

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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)
Marketed in the U.S.
Since 2023
Label revision date
September 8, 2025
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
Marketed in the U.S.
Since 2023
Label revision date
September 8, 2025
Manufacturer
Rising Pharma Holdings, Inc.
Registration number
M007.54
NDC root
57237-326

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Drug Overview

Children's Glycerin Suppositories are a type of laxative designed to provide fast and gentle relief from occasional constipation in children aged 2 to 5 years. When used, these suppositories typically help produce a bowel movement within 15 minutes to 1 hour, making them a convenient option for parents seeking to alleviate their child's discomfort from constipation.

Uses

If you're experiencing occasional constipation, this product can help provide fast and gentle relief. It typically works within 15 minutes to 1 hour, making it a convenient option when you need quick results. This medication is suitable for children aged 2 to 5 years, ensuring that even young ones can find relief when they need it.

Dosage and Administration

If you have a child aged 2 to under 6 years, you can give them 1 suppository (a small, solid medication inserted into the rectum) once a day. For children under 2 years old, it’s important to consult a doctor before administering this medication.

To use the suppository, you should insert it well into your child's rectum and have them hold it in for about 15 minutes. Keep in mind that the suppository does not need to melt in order to work effectively as a laxative (a medication that helps relieve constipation).

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 ensure your safety and the effectiveness of the treatment. Always follow your healthcare provider's advice regarding the use of any medication.

Side Effects

When using this product, your child may experience some rectal discomfort or a burning sensation. It's important to monitor your child closely. 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 serious condition.

Before using this product, you should also talk to 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 medical help or contact a Poison Control Center immediately. You should also stop using the product and call your doctor if your child has rectal bleeding or does not have a 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 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 may include unusual symptoms, but specific details about these symptoms are not provided here. Always err on the side of caution and get help if you suspect an overdose has occurred. Your safety is the top priority, so don’t hesitate to reach out for assistance.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during this time.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication or product to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is between 2 and 5 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. This product typically helps produce a bowel movement within 15 minutes to 1 hour.

Before using this product, check with a doctor if your child has stomach pain, nausea, vomiting, or has experienced a sudden change in bowel habits lasting more than 2 weeks. While using the 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 and consult a doctor immediately.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present. Always follow their guidance on dosage and safety to ensure the best outcomes.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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, 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 clean hands and in a clean environment to maintain its integrity. If there are any specific components included with the product, make sure to follow any additional instructions provided for their use and safety. Proper disposal methods should also be followed to ensure safety and compliance with local regulations.

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.

FAQ

What is Children's Glycerin Suppositories used for?

Children's Glycerin Suppositories are a laxative used for fast, gentle relief of occasional constipation in children aged 2 to 5 years.

How quickly does this product work?

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

What is the recommended dosage for children aged 2 to 5 years?

For children aged 2 to 5 years, the recommended dosage is 1 suppository once daily.

What should I do if my child is under 2 years old?

If your child is under 2 years old, you should ask a doctor before use.

How should the suppository be administered?

Insert 1 suppository well up into the rectum and retain it for 15 minutes.

Are there any warnings associated with this product?

Yes, this product is for rectal use only, and you should stop use and ask a doctor if your child experiences rectal bleeding or no bowel movement after using it.

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

You should ask a doctor before using this product if your child has stomach pain, nausea, vomiting, or a sudden change in bowel habits lasting more than 2 weeks.

Can this product be used for longer than one week?

Do not use this product for longer than one week unless directed by a doctor.

What should I do if the suppository is swallowed?

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

Are there any known side effects?

When using this product, your child may experience rectal discomfort or a burning sensation.

Packaging Info

Below are the non-prescription pack sizes of Glycerin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Glycerin.
Details

Drug Information (PDF)

This file contains official product information for Glycerin, 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 drug.

Uses and Indications

This drug is indicated for the relief of occasional constipation in pediatric patients aged 2 to 5 years. It is designed to provide fast and gentle relief, typically producing a bowel movement within 15 minutes to 1 hour of administration.

There are no teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

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 physician prior to administration.

The administration of the suppository should be performed by inserting it well up into the rectum. It is important to ensure that the suppository is retained for a minimum of 15 minutes to achieve the desired laxative effect. Notably, the suppository does not need to melt in order to produce its laxative action.

Contraindications

Use of this product is contraindicated for durations exceeding one week unless directed by a healthcare professional. Prolonged use may lead to potential adverse effects that require medical supervision. No other specific contraindications have been identified in the available data.

Warnings and Precautions

For rectal use only. This product should not be utilized 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: stomach pain, nausea, vomiting, or 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 advise patients to discontinue use and consult a doctor if the child exhibits any of the following symptoms: 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 certain adverse reactions. It is important to note that this product is intended for rectal use only. Commonly reported reactions include rectal discomfort and a burning sensation, which may occur during application.

In the event that a child experiences rectal bleeding or does not have a bowel movement after using this product, it is advised to stop use immediately and consult a healthcare professional, as these symptoms may indicate a serious condition. Additionally, caregivers should seek medical advice prior to 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.

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 Glycerin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Glycerin.
Details

Pediatric Use

Pediatric patients aged 2 to 5 years may be administered 1 suppository once daily. For children under 2 years of age, consultation with a healthcare professional is advised prior to use. This product typically induces a bowel movement within 15 minutes to 1 hour.

Healthcare professionals should advise caregivers to seek medical advice before using this product if the child experiences stomach pain, nausea, vomiting, or a sudden change in bowel habits lasting more than 2 weeks. While using this product, children may experience rectal discomfort or a burning sensation. If rectal bleeding occurs or if there is no bowel movement after use, caregivers should discontinue use and consult a doctor.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data 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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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.

It is important to inform patients that this product should not be used for longer than one week unless directed by a healthcare professional. Patients should be made aware that they need to stop using the product and consult a doctor if their child experiences rectal bleeding or does not have a bowel movement after using the product, as these symptoms may indicate a serious condition.

While using this product, patients should be informed that their child may experience rectal discomfort or a burning sensation. Additionally, healthcare providers should recommend that patients consult a doctor before using the product if their 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 container requirements should be adhered to, and any special handling needs must be followed to ensure optimal storage conditions.

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.

Drug Information (PDF)

This file contains official product information for Glycerin, 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 Glycerin, 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.