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Minica-S

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This product has been discontinued

Active ingredient
Glycerin 80 mL/100 mL
Other brand names
Dosage form
Enema
Route
Rectal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1994
Label revision date
December 7, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Glycerin 80 mL/100 mL
Other brand names
Dosage form
Enema
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 1994
Label revision date
December 7, 2023
Manufacturer
Sato Pharmaceutical Co. , Ltd.
Registration number
M007
NDC root
49873-401
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

This medication is designed to provide relief from occasional constipation, helping to promote regular bowel movements. It typically works within a timeframe of 15 minutes to 1 hour after taking it, making it a quick option for those experiencing irregularity.

Since it has been effective since January 24, 2012, you can trust that it has been used by many to help manage their digestive health. If you're looking for a solution to occasional constipation, this product may be a suitable choice for you.

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.

You can feel confident using this product, as there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refer to other types of harmful effects during pregnancy).

Dosage and Administration

If you or your child is 6 years old or older and need to use a glycerin rectal enema, you will typically use one enema containing 8 mL of glycerin each day, or as your doctor advises. To use the enema, gently insert the tip of the applicator into the rectum, making sure the tip is pointing toward the navel. Squeeze the unit until almost all of the liquid is released, then carefully remove the tip.

For children under 6 years old, it’s important to consult with a doctor before using this product. Always follow your healthcare provider's instructions regarding the use and frequency of this medication.

What to Avoid

It's important to use this preparation responsibly to avoid potential issues. Frequent or prolonged use can lead to dependence on laxatives, which means you may find it difficult to have regular bowel movements without them. To ensure your safety, do not use this product for more than one week unless your doctor specifically advises you to do so. Always prioritize your health and consult with a healthcare professional if you have any concerns.

Side Effects

This product is intended for rectal use only and should not be used for more than one week unless your doctor advises otherwise. Prolonged use may lead to dependence on laxatives. Before using, consult your doctor if you experience abdominal pain, nausea, vomiting, or a sudden change in bowel habits that lasts for two weeks.

While using this product, you might experience some rectal discomfort or a burning sensation. If you notice rectal bleeding or do not have a bowel movement after using the laxative, stop using it and contact your doctor, as these could be signs of a serious condition. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

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, as frequent or prolonged use can lead to dependence on laxatives.

Before using this product, consult your doctor if you have abdominal pain, nausea, or vomiting, or if you've noticed a sudden change in your bowel habits that lasts for two weeks. While using the product, you may experience some rectal discomfort or a burning sensation.

If you experience rectal bleeding or do not have a bowel movement after using the laxative, stop using it and contact your doctor, as these could be signs of a serious condition. Keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

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 can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Minica-S (glycerin enema) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been clearly established.

Before using Minica-S or any medication while pregnant, it’s best to consult with your healthcare provider to discuss potential risks and benefits. They can provide guidance tailored to your individual health needs and circumstances.

Lactation Use

If you are breastfeeding and considering the use of Minica-S glycerin enema, it's important to note that the drug insert does not provide specific information about its effects on nursing mothers or lactation. This means there is no clear guidance on how this medication may impact your breast milk or your nursing infant.

As always, it's best to consult with your healthcare provider before using any medication while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

If you have a child under 6 years old, it's important to consult with a doctor before using this medication. For children aged 6 years and older, the recommended dosage is one rectal enema containing 8 mL of Glycerin each day, or as directed by your healthcare provider. Always follow your doctor's instructions to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor to ensure safe and effective treatment.

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 is safe and effective for your specific condition. They can help you understand how your kidney health may affect your medication and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while considering your liver condition.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store and use it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use.

Additional Information

No further information is available.

FAQ

What is the primary use of this product?

This product is used for the relief of occasional constipation (irregularity).

How quickly does this product work?

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

What is the recommended dosage for adults and children over 6 years?

Adults and children 6 years and over should use 1 rectal enema containing 8 mL of Glycerin daily or as directed by a doctor.

What should I do if I have abdominal pain or a sudden change in bowel habits?

You should ask a doctor before using this product if you have abdominal pain, nausea, vomiting, or a sudden change in bowel habits that persists for 2 weeks.

Are there any warnings associated with this product?

Yes, this product is for rectal use only and should not be used for longer than 1 week unless directed by a doctor.

What should I do if I experience rectal bleeding or failure to have a bowel movement after use?

You should stop use and ask a doctor, as this may indicate a serious condition.

Is there a risk of dependence on this product?

Yes, frequent or prolonged use may result in dependence on laxatives.

What should I do if this product is swallowed?

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

Is this product safe for children under 6 years?

For children under 6 years, you should ask a doctor before use.

How should this product be stored?

Store and use this product at room temperature.

Packaging Info

Below are the non-prescription pack sizes of Minica-S (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Minica-S.
Details

Drug Information (PDF)

This file contains official product information for Minica-S, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the relief of occasional constipation (irregularity). It generally produces a bowel movement within 15 minutes to 1 hour after administration.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 years and older are advised to administer one rectal enema containing 8 mL of Glycerin daily, or as directed by a healthcare professional. For administration, the user should gently insert the stem with the tip pointing toward the navel. The unit should be squeezed until nearly all of the liquid is expelled, after which the tip should be removed from the rectum.

For children under 6 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

Use of this preparation is contraindicated in patients who require laxative use for longer than one week without medical supervision, due to the potential for dependence on laxatives. Frequent or prolonged use may lead to laxative dependence, which can complicate treatment and management of underlying conditions.

Warnings and Precautions

For rectal use only. This product is not intended for use beyond one week unless specifically directed by a healthcare professional. Prolonged or frequent use may lead to dependence on laxatives.

Healthcare professionals should advise patients to consult a doctor prior to use if they experience abdominal pain, nausea, or vomiting, or if they notice a sudden change in bowel habits that persists for two weeks or longer.

During the use of this product, patients may experience rectal discomfort or a burning sensation. It is crucial to monitor for any adverse effects.

Patients should discontinue use and seek medical advice if they experience rectal bleeding or if there is a failure to have a bowel movement after using the laxative, as these symptoms may indicate a serious underlying condition.

This product should be kept 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 should be aware that this product is intended for rectal use only. It is important to adhere to the recommended duration of use, as it should not be used for longer than one week unless directed by a healthcare professional. Frequent or prolonged use of this preparation may lead to dependence on laxatives.

Before using this product, patients are advised to consult a doctor if they experience abdominal pain, nausea, or vomiting, or if they notice a sudden change in bowel habits that persists for a period of two weeks.

While using this product, patients may experience rectal discomfort or a burning sensation. If rectal bleeding occurs or if there is a failure to have a bowel movement after using the laxative, patients should stop use and seek medical advice, as these symptoms may indicate a serious condition.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact a Poison Control Center without delay.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Minica-S (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Minica-S.
Details

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 dosage is one rectal enema containing 8 mL of Glycerin daily, or as directed by a healthcare provider.

Geriatric Use

There is no specific information available 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, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Minica-S (glycerin enema) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients due to the lack of data on its effects on fetal outcomes. It is advisable to weigh the potential benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

There is no specific information available regarding the use of Minica-S glycerin enema in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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 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 of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In summary, swift action and appropriate medical response are vital in managing cases of overdosage to ensure patient safety and effective treatment.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product should not be used for longer than one week unless directed by a healthcare professional. They should be made aware that frequent or prolonged use may lead to dependence on laxatives.

Providers should instruct patients to discontinue use and consult a doctor if they experience rectal bleeding or fail to have a bowel movement after using the laxative, as these symptoms may indicate a serious underlying condition.

While using this product, patients may experience rectal discomfort or a burning sensation, and they should be made aware of this potential side effect.

Additionally, healthcare providers should encourage patients to consult a doctor before using this product if they have abdominal pain, nausea, or vomiting. Patients should also be advised to seek medical advice if they notice a sudden change in bowel habits that persists for 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 and use the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Minica-S, 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 Minica-S, 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.