Glycerin

Description

Glycerin is the active ingredient in this formulation, which is presented in the form of suppositories. These suppositories serve as a laxative, providing fast and gentle relief from occasional constipation. Each package contains 12 adult suppositories. The product is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895. It is important to note that the product should not be used if the printed inner seal is broken or missing. This formulation is not manufactured or distributed by C.B. Fleet Co., the owner of the registered trademark Fleet®.

Uses and Indications

This drug is indicated for the relief of occasional constipation. It provides fast and gentle relief for patients experiencing this condition.

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

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is to carefully insert one suppository well into the rectum. This administration should not exceed once per day. The suppository typically induces a bowel movement within 15 minutes to 1 hour following insertion.

For children under 6 years of age, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used more than once per day. Prolonged use beyond one week is contraindicated unless directed by a healthcare professional. Additionally, the use of laxative products is contraindicated in patients experiencing abdominal pain, nausea, or vomiting, unless specifically directed by a doctor. Finally, do not use the product if the seal under the product lid is damaged, missing, or broken, as this may compromise safety and efficacy.

Warnings and Precautions

Rectal use of this product is strictly indicated; it is not intended for any other route of administration. Users should be aware that the application may lead to rectal discomfort or a burning sensation.

It is imperative to adhere to the following precautions to ensure safe usage. The product should not be used more than once per day. Additionally, it is advised against using the product for longer than one week unless specifically directed by a healthcare professional. Caution is warranted when considering the use of laxative products in the presence of abdominal pain, nausea, or vomiting; such use should only occur under the guidance of a physician. Furthermore, the product must not be used if the seal under the lid is damaged, missing, or broken, as this may compromise safety and efficacy.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should 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 an underlying condition requiring medical evaluation.

Side Effects

Patients using this product may experience adverse reactions, which can include rectal discomfort or a burning sensation, particularly with rectal use. It is important for patients to be aware of specific warnings associated with the use of this product.

Patients should discontinue use and consult a healthcare professional if they experience rectal bleeding or if they do not have a bowel movement after using the laxative, as these symptoms may indicate a more serious underlying condition. Additionally, patients are advised to seek medical advice before using this product if they have noticed a sudden change in bowel habits that persists for two weeks, or if they are pregnant or nursing a baby.

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 under 6 years of age should consult a healthcare professional before use. For children aged 6 years and older, the recommended administration involves careful insertion of one suppository into the rectum.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

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 use effective contraception during treatment. If a patient becomes pregnant while taking this medication, healthcare providers should counsel her regarding the potential risks to fetal outcomes and consider alternative treatment options.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are breastfeeding. 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 drug insert text 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 there is no available data to guide dosing or monitoring in this 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 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided 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 exceed the recommended dosage of one use per day. Additionally, patients should be cautioned against using the product for more than one week unless specifically directed by a healthcare professional.

Providers should emphasize that laxative products should not be used in the presence of abdominal pain, nausea, or vomiting unless directed by a doctor. Patients must be informed that the product should not be used if the seal under the product lid is damaged, missing, or broken, as this may compromise safety.

Patients should be instructed to discontinue use and consult a doctor if they experience rectal bleeding or do not have a bowel movement after using the laxative, as these symptoms may indicate a more serious condition. Furthermore, healthcare providers should encourage patients to seek medical advice before using the product if they have noticed a sudden change in bowel habits that persists for two weeks or if they are pregnant or nursing a baby.

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 imperative that the temperature does not exceed 30° C (86° F) to maintain the product's efficacy.

Additional Clinical Information

The route of administration for the medication is rectal. For adults and children aged 6 years and older, it is recommended to carefully insert one suppository well into the rectum. Patients should not exceed a frequency of 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)