Glycerin

Description

Children's Glycerin Suppositories, distributed by Meijer Distribution, Inc., are formulated as a laxative for the fast and gentle relief of occasional constipation. Each package contains 12 suppositories. The product is comparable to Fleet® active ingredient, although it is not manufactured or distributed by C.B. Fleet Co., the owner of the registered trademark Fleet®. The National Drug Code (NDC) for this product is 41250-404-12. Meijer Pharmacist Recommended.

Uses and Indications

This drug is indicated for the relief of occasional constipation.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For children aged 2 to 6 years, one suppository should be carefully inserted well into the rectum. This administration should not exceed once per day. The expected onset of action typically results in a bowel movement within 15 minutes to 1 hour following administration.

For children under 2 years of age, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Administration of more than one unit per day is prohibited.

• Prolonged use beyond one week is contraindicated unless directed by a healthcare professional.

• The use of laxative products is contraindicated in the presence of abdominal pain, nausea, or vomiting, unless specifically directed by a healthcare professional.

• The product should not be used if the seal under the product lid is damaged, missing, or broken.

Warnings and Precautions

For rectal use only, this product may cause rectal discomfort or a burning sensation.

It is imperative that the product is not used more than once per day and should not be used for a duration exceeding one week unless specifically directed by a healthcare professional. The use of laxative products is contraindicated in the presence of abdominal pain, nausea, or vomiting unless advised by a physician. Additionally, the product should not be used if the seal under the product lid is damaged, missing, or broken.

Healthcare professionals should advise patients to consult a doctor prior to use if they have experienced a sudden change in bowel habits that persists for two weeks or longer. Pregnant or nursing individuals should also seek medical advice before using this product.

Patients must discontinue use and consult a healthcare provider if they experience rectal bleeding or do not have a bowel movement after using the laxative, as these symptoms may indicate a serious underlying condition.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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. These symptoms are generally mild but can be bothersome.

In the event of rectal bleeding or failure to have a bowel movement after using the laxative, patients are advised to stop use and consult a doctor. Such symptoms may indicate a serious underlying condition that requires medical attention.

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.

Pediatric Use

Pediatric patients aged 2 to 6 years should have one suppository carefully inserted well into the rectum, with a maximum frequency of once per day. This administration typically results in a bowel movement within 15 minutes to 1 hour. For children under 2 years of age, consultation with a healthcare professional is advised prior to 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to pregnant patients. Due to the lack of data, it is recommended that women of childbearing potential discuss their pregnancy status and any potential risks with their healthcare provider before initiating treatment. Further studies may be necessary to fully understand the implications of this medication on fetal outcomes.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are nursing a baby. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 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 not use more than one dose per day and that the product should not be used for longer than one week unless directed by a healthcare professional.

Patients should be cautioned against using laxative products if they are experiencing abdominal pain, nausea, or vomiting, unless specifically directed by a doctor. Additionally, they should be instructed to check the product seal; if it is damaged, missing, or broken, they should not use the product.

Healthcare providers should emphasize the importance of stopping use and consulting a doctor if patients experience rectal bleeding or do not have a bowel movement after using the laxative, as these symptoms may indicate a serious condition. Patients should also be encouraged to discuss any sudden changes in bowel habits that persist for two weeks with their healthcare provider before using the product.

Finally, it is essential to advise patients to consult a doctor if they are pregnant or nursing a baby prior to using the product.

Storage and Handling

The product is supplied in a tightly sealed container to ensure integrity and stability. It should be stored at room temperature, specifically within the range of 15° to 30° C (59° to 86° F). It is crucial to avoid exceeding the maximum temperature of 30° C (86° F) to maintain the product's efficacy.

Additional Clinical Information

The route of administration for the medication is rectal. For children aged 2 to 6 years, clinicians should instruct caregivers to carefully insert one suppository well into the rectum, ensuring that it is not used more than once per day. 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 Glycerin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)