Infant Glycerin Laxative

Description

Sunmark® is a laxative formulation available in the form of suppositories, designed for the fast and gentle relief of occasional constipation. Each package contains 25 suppositories, with glycerin as the active ingredient. This product is intended for pediatric use and is distributed by McKesson, located at One Post Street, San Francisco, CA 94104. The National Drug Code (NDC) for this product is 49348-158-05. It is important to note that this product 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 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:

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.

To ensure safe usage, it is imperative that individuals do not exceed the recommended dosage of one application per day. Prolonged use beyond one week is contraindicated unless specifically directed by a healthcare professional. Caution is advised against the use of laxative products in the presence of abdominal pain, nausea, or vomiting, unless a physician has provided guidance. Additionally, the product should 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 are advised to discontinue use and consult a healthcare provider if they experience rectal bleeding or if there is a failure to have a bowel movement after using the laxative. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 reactions, while generally mild, can be uncomfortable for some individuals.

In the event of rectal bleeding or failure to have a bowel movement after using the laxative, patients are advised to stop use immediately and consult a healthcare professional, as these symptoms may indicate a serious underlying condition.

Additionally, patients should seek medical advice before using this product if they have experienced a sudden change in bowel habits that persists for two weeks or longer, or if they are pregnant or nursing.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Infant Glycerin Laxative (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 dosage 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.

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 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 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 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.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 should refrain from using the product for longer than one week unless specifically directed by a healthcare professional.

Patients should be cautioned against using laxative products if they are experiencing abdominal pain, nausea, or vomiting, unless directed by a doctor. Additionally, they should be instructed to avoid using the product if the seal under the product lid is damaged, missing, or broken.

Healthcare providers should emphasize the importance of stopping the use of the product 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. It is also advisable for patients to consult a doctor if they notice a sudden change in bowel habits that persists for two weeks.

Lastly, healthcare providers should remind patients to ask a doctor before using the product 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 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. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Infant Glycerin Laxative, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)