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Glycerin

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This product has been discontinued

Active ingredient
Glycerin 1.2 g
Other brand names
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 2012
Label revision date
December 12, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Glycerin 1.2 g
Other brand names
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 2012
Label revision date
December 12, 2024
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
M007
NDC root
63868-282
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

Pediatric Glycerin Suppositories are a type of medication designed to help relieve occasional constipation in children. When used, they typically work by promoting a bowel movement within 15 minutes to 1 hour, providing quick relief for your little one.

These suppositories are distributed by C.D.M.A. Inc. and are available in a package containing 25 units, making them a convenient option for parents seeking to manage their child's constipation effectively.

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. This makes it a convenient option when you need fast relief from discomfort.

Dosage and Administration

When using this medication, you will take a single dose each day. For children aged 2 to under 6 years, the recommended dosage is one suppository, unless your doctor advises otherwise. If your child is under 2 years old, it’s important to consult with a doctor before administering the medication.

To use the suppository, make sure to insert it well into the rectum. You don’t need to worry if the suppository doesn’t melt completely; it can still work effectively to relieve constipation. Always follow the guidance of your healthcare provider for the best results.

What to Avoid

It's important to be aware of specific situations where you should stop using this product and consult a doctor. If your child experiences rectal bleeding or does not have a bowel movement within one hour of using this product, you should seek medical advice immediately.

Currently, there are no listed contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always prioritize your child's health and safety by following these guidelines.

Side Effects

When using this product, it's important to remember that it is intended for rectal use only. You may experience some discomfort or a burning sensation in the rectal area. If your child has abdominal pain, nausea, vomiting, or a sudden change in bowel habits lasting more than two weeks, consult a doctor before using any laxative.

You should also stop using the product and seek medical advice if your child experiences rectal bleeding or does not have a bowel movement within one hour of use, as these could be signs of a more serious condition.

Warnings and Precautions

This product is intended for rectal use only and may cause some discomfort or a burning sensation. If your child is experiencing abdominal pain, nausea, or vomiting, or if there has been a sudden change in bowel habits lasting more than two weeks, it’s important to consult a doctor before using any laxative. Additionally, if a laxative has already been used for more than one week, seek medical advice.

You should stop using this product and call your doctor if your child experiences rectal bleeding or does not have a bowel movement within one hour of use, as these could be signs of a more serious condition. If the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to seek immediate medical attention. Your safety is the top priority, so getting help quickly can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

Before using any laxative for your child, it's important to consult with a doctor if your child has abdominal pain, nausea, or vomiting, has experienced a sudden change in bowel habits lasting more than two weeks, or has already been using a laxative for more than one week. If your child experiences rectal bleeding or does not have a bowel movement within one hour of using the product, you should stop use and seek medical advice immediately.

For dosing, children aged 2 to under 6 years can typically use one suppository daily, or as directed by a doctor. If your child is under 2 years old, please consult a doctor before use. Always prioritize your child's health and safety by following these guidelines.

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 factors like overall health and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor are essential to ensure safety and effectiveness.

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 kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that your treatment is as safe and effective as possible.

Storage and Handling

To ensure the safety and effectiveness of your product, always store the container tightly closed. This helps protect the contents from contamination and maintains their quality. Additionally, keep the product away from excessive heat, as high temperatures can compromise its integrity.

When handling the product, be mindful of these storage guidelines to ensure optimal performance. Proper storage not only safeguards the product but also contributes to your overall safety during use.

Additional Information

No further information is available.

FAQ

What is Pediatric Glycerin Suppositories used for?

Pediatric Glycerin Suppositories are used for the relief of occasional constipation.

How quickly do Pediatric Glycerin Suppositories work?

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

What is the recommended dosage for children aged 2 to under 6 years?

Children aged 2 to under 6 years should use 1 suppository, or as directed by a doctor.

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.

What should I do if my child experiences rectal bleeding?

You should stop use and consult a doctor if your child has rectal bleeding.

What precautions should I take before using this product?

Ask a doctor before using any laxative if your child has abdominal pain, nausea, vomiting, or a sudden change in bowel habits lasting more than 2 weeks.

Can I use Pediatric Glycerin Suppositories if my child has not had a bowel movement within 1 hour?

You should stop use and consult a doctor if your child has not had a bowel movement within 1 hour of using this product.

Are there any warnings associated with Pediatric Glycerin Suppositories?

Yes, this product is for rectal use only and may cause rectal discomfort or a burning sensation.

What should I do if the suppository is swallowed?

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

Is there any information regarding the use of this product during pregnancy?

No specific information regarding the use of this product during pregnancy is provided; consult a doctor.

What about nursing mothers?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

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

Pediatric Glycerin Suppositories are supplied in a package containing 25 units. These suppositories are distributed by C.D.M.A. Inc., located at 43157 W. Nine Mile, Novi, MI 48376-0995. For further information, visit the website at www.qualitychoice.com.

Uses and Indications

This drug is indicated for the relief of occasional constipation. It generally produces a bowel movement within 15 minutes to 1 hour after 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, or as directed by a healthcare professional. For children under 2 years of age, it is advised to consult a physician prior to administration.

The suppository should be inserted well up into the rectum to ensure proper placement. It is important to note that the suppository does not need to melt completely in order to achieve the desired laxative effect.

Contraindications

Use of this product is contraindicated in children who experience rectal bleeding or have not had a bowel movement within one hour of administration. In such cases, it is essential to discontinue use and consult a healthcare professional for further evaluation and management.

Warnings and Precautions

For rectal use only, this product may cause rectal discomfort or a burning sensation. Healthcare professionals should advise patients to monitor for these potential side effects.

It is essential to exercise caution when administering this laxative, particularly in pediatric patients. Prior to use, healthcare providers should recommend that caregivers consult a physician if the child presents with any of the following conditions: abdominal pain, nausea, or vomiting; a sudden change in bowel habits lasting more than two weeks; or if a laxative has already been used for more than one week.

Patients should be instructed to discontinue use and seek medical advice if the child experiences rectal bleeding or does not have a bowel movement within one hour of using the product. These symptoms may indicate a serious underlying condition that requires further evaluation.

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

Side Effects

Patients using this product should be aware that it is intended for rectal use only. Common adverse reactions may include rectal discomfort or a burning sensation.

It is advised that patients consult a doctor before using any laxative if the child has abdominal pain, nausea, or vomiting, experiences a sudden change in bowel habits lasting more than two weeks, or has already used a laxative for more than one week.

Patients should discontinue use and seek medical advice if the child experiences rectal bleeding or does not have a bowel movement within one hour of using this product, as these symptoms may indicate a serious condition.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary 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 should be evaluated by a healthcare professional before using any laxative, particularly if they present with abdominal pain, nausea, vomiting, a sudden change in bowel habits lasting more than 2 weeks, or if they have already used a laxative for more than 1 week.

If a child experiences rectal bleeding or does not have a bowel movement within 1 hour of using this product, use should be discontinued, and a doctor should be consulted.

For dosing, children aged 2 to under 6 years may use 1 suppository daily, or as directed by a healthcare provider. For children under 2 years, it is advised to consult a doctor before use.

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 is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data in pregnancy and the importance of discussing any plans for pregnancy or breastfeeding with their healthcare provider.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on the nursing infant are not well studied; therefore, caution is advised.

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 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 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 may include supportive care and symptomatic treatment, tailored to the patient's clinical presentation. Continuous evaluation and appropriate interventions should be implemented as necessary to ensure patient safety and recovery.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that they should discontinue use and consult a doctor if their child experiences rectal bleeding. Additionally, patients should be instructed to stop using the product and seek medical advice if their child does not have a bowel movement within one hour of administration. Healthcare providers should emphasize that these symptoms may indicate a serious condition and warrant prompt medical evaluation.

Storage and Handling

The product is supplied in a tightly sealed container to ensure integrity and stability. It is essential to store the container in a cool, dry place, away from excessive heat to maintain optimal conditions. Proper handling includes keeping the container tightly closed when not in use to prevent contamination and degradation of the product.

Additional Clinical Information

No further data are available.

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.

Learn more in our Editorial Policy

Last AI update:

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.