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Pen Prep

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This product has been discontinued

Active ingredient
Magnesium Citrate 17 g/100 g
Other brand names
Dosage form
Powder, for Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
November 22, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Magnesium Citrate 17 g/100 g
Other brand names
Dosage form
Powder, for Solution
Route
Oral
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 2010
Label revision date
November 22, 2011
Manufacturer
PEN Prep LLC
Registration number
part331
NDC root
76334-001
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

PEN PREP TM CITRATE OF MAGNESIUM is a liquid medication designed to help relieve occasional constipation, which is when you experience irregular bowel movements. This product comes in a 10 fluid ounce bottle after it has been reconstituted, making it easy to use when you need relief from discomfort caused by constipation.

If you're experiencing irregularity, this medication can provide the support you need to help restore regular bowel function. Always ensure that the product is sealed properly before use for your safety.

Uses

You can use this medication to help relieve occasional constipation, which is when you experience irregular bowel movements. It's designed to make it easier for you to have regular and comfortable trips to the bathroom.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause birth defects if taken during pregnancy. Additionally, there are no reported nonteratogenic effects, which means it doesn't have harmful effects that aren't related to birth defects.

Dosage and Administration

To prepare your medication, start by filling the bottle to the top of the label with cold water or another liquid. After adding the liquid, shake the bottle thoroughly to mix everything well. If you’re not using it right away, you can refrigerate the mixture, but remember to shake it again before each use.

It's important to use the medication as directed by your doctor. Once you’ve reconstituted (mixed) the medication, make sure to use it within 36 hours, as it should not be used after that time. If the medication is for a child under 12, be sure to consult your doctor for specific guidance.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or risks related to these aspects. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should be aware of some important side effects and warnings associated with this product. If you are allergic to magnesium citrate, do not use it. It's also advisable to consult a doctor if you experience nausea, vomiting, abdominal pain, or a sudden change in bowel habits lasting more than two weeks. While using this product, you may notice loose, watery, or more frequent stools.

If you have kidney disease, are pregnant, or are breastfeeding, please speak with a healthcare professional before using this product. Your health and safety are important, so don't hesitate to reach out for guidance if you have any concerns.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. First, do not use it if you are allergic to magnesium citrate. It's crucial not to exceed the maximum dose within a 24-hour period. If you have kidney disease, nausea, vomiting, abdominal pain, or a sudden change in bowel habits lasting more than two weeks, consult your doctor before using this product. Additionally, if you are taking any prescription medications, check with your doctor or pharmacist first, and take this product at least two hours before or after your other medications. While using this product, you may experience loose, watery, or more frequent stools. If you are pregnant or breastfeeding, please consult a healthcare professional before use.

In case of an overdose, seek emergency medical help or contact a poison control center immediately. If you experience any concerning symptoms, it’s best to stop using the product and reach out to your doctor for guidance.

Overdose

Taking more than the recommended maximum dose of a medication within a 24-hour period can lead to an overdose. Signs of an overdose may include unusual symptoms that are not typical for you, and it’s important to be aware of these changes.

If you suspect an overdose, seek immediate medical help. It’s crucial to act quickly, as timely intervention can make a significant difference. Always follow the dosing instructions provided to avoid exceeding the maximum dose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on any potential risks or effects on your milk production and your nursing infant. Always prioritize your health and your baby's well-being by seeking expert advice.

Pediatric Use

If you are considering this medication for a child under 12 years old, it’s important to consult with your doctor first. They can provide guidance on whether this treatment is appropriate for your child's specific needs and circumstances. Always prioritize your child's health and safety by seeking professional advice before starting any new medication.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize your kidney health and follow your doctor's guidance closely.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this product, especially if you are currently taking any prescription medications. This is to ensure that there are no harmful interactions between the products.

Additionally, make sure to take this product at least two hours before or after taking other medications. This timing helps to avoid any potential interference with how the medications work in your body. Always prioritize open communication with your healthcare provider about all the medications and supplements you are using.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. If you need to reconstitute (mix) the product, remember to refrigerate it afterward and give it a good shake before use. It's important to use the product within 36 hours after reconstitution to maintain its quality.

Always keep the product out of reach of children. Additionally, check the tamper-proof cap before use; do not use the product if the cap is open or broken, as this indicates it may not be safe. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What is PEN PREP TM CITRATE OF MAGNESIUM used for?

PEN PREP TM CITRATE OF MAGNESIUM is used to relieve occasional constipation (irregularity).

How should I prepare PEN PREP TM CITRATE OF MAGNESIUM?

Fill the bottle to the top of the label with cold water or other liquids, shake thoroughly, and refrigerate if needed. Use within 36 hours of reconstitution.

Are there any allergies I should be aware of?

Do not use PEN PREP TM CITRATE OF MAGNESIUM if you are allergic to magnesium citrate.

What should I do if I experience nausea or abdominal pain?

Ask a doctor before using PEN PREP TM CITRATE OF MAGNESIUM if you have nausea, vomiting, or abdominal pain.

Can I use this product if I have kidney disease?

You should ask a doctor before using PEN PREP TM CITRATE OF MAGNESIUM if you have kidney disease.

Is it safe to use PEN PREP TM CITRATE OF MAGNESIUM during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using this product.

What should I do in case of overdose?

In case of overdose, get medical help or contact a poison control center immediately.

What are the storage instructions for this product?

Store PEN PREP TM CITRATE OF MAGNESIUM at room temperature and keep it out of reach of children.

What should I do if the tamper-proof cap is broken?

Do not use PEN PREP TM CITRATE OF MAGNESIUM if the tamper-proof cap is open or broken.

Can children under 12 use this product?

For children under 12, you should ask your doctor before use.

Packaging Info

Below are the non-prescription pack sizes of Pen Prep (magnesium citrate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pen Prep.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PEN PREP™ Citrate of Magnesium is provided in a dosage form of 10 fluid ounces after reconstitution. The product is designed to be tamper-evident, and it should not be used if the tamper-proof cap is open or broken.

Uses and Indications

This drug is indicated for the relief of occasional constipation (irregularity).

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

Dosage and Administration

Healthcare professionals should instruct patients to fill the bottle to the top of the label with cold water or other liquids and shake thoroughly to ensure proper reconstitution. If necessary, the reconstituted solution may be refrigerated; however, it must be shaken again before use.

It is critical to note that the reconstituted solution should not be used after 36 hours. Dosage and administration should be carried out as directed by the prescribing physician. For pediatric patients under the age of 12, consultation with a healthcare provider is recommended prior to use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

ALLERGY ALERT: This product should not be used by individuals who are allergic to magnesium citrate.

It is imperative that the maximum recommended dose is not exceeded within a 24-hour period. Healthcare professionals should advise patients to consult a physician prior to use if they have a history of kidney disease, experience nausea, vomiting, or abdominal pain, or if there has been a sudden change in bowel habits lasting more than two weeks.

Patients currently taking prescription medications should seek guidance from a doctor or pharmacist before using this product. It is recommended that this product be taken at least two hours before or after the administration of other drugs to avoid potential interactions.

While using this product, patients may experience loose, watery, and more frequent stools. Therefore, monitoring for gastrointestinal symptoms is advised.

For pregnant or breastfeeding individuals, it is essential to consult a healthcare professional before use to ensure safety for both the mother and child.

In the event of an overdose, immediate medical assistance should be sought, or contact a poison control center without delay.

Patients should be advised to discontinue use and consult their healthcare provider if they experience any concerning symptoms or adverse effects.

Side Effects

Patients may experience a range of adverse reactions when using this product. It is important to note that individuals with specific conditions should consult a healthcare professional prior to use.

Serious adverse reactions include severe allergic reactions in patients who are allergic to magnesium citrate. Additionally, patients experiencing nausea, vomiting, or abdominal pain should seek medical advice before using this product. A sudden change in bowel habits lasting more than two weeks is another serious condition that warrants consultation with a healthcare provider prior to use.

Common adverse reactions reported include loose, watery, and more frequent stools, which may occur during the use of this product. Patients with kidney disease should also consult a doctor before use, as this condition may influence the safety and efficacy of the product. Furthermore, pregnant or breastfeeding individuals are advised to seek guidance from a health professional before using this product to ensure safety for both the mother and child.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product if they are currently taking any prescription medications. This precaution is essential to avoid potential drug interactions that may affect the efficacy or safety of the treatments involved.

To minimize the risk of interactions, it is recommended that this product be taken at least two hours before or after the administration of other medications. This timing helps to ensure that the absorption and action of both this product and any concurrent medications are not adversely affected.

Packaging & NDC

Below are the non-prescription pack sizes of Pen Prep (magnesium citrate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pen Prep.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered in these populations. There is limited data available regarding the effects of this medication on fetal outcomes or during lactation, and therefore, healthcare providers should evaluate the necessity of treatment against any potential risks to the mother and child.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. 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 administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 overdosage, it is critical to adhere to the maximum recommended dose within a 24-hour period to prevent adverse effects. Exceeding this limit may lead to serious health complications.

Healthcare professionals should be vigilant for potential symptoms associated with overdosage, which may vary depending on the specific circumstances and individual patient factors. It is essential to monitor patients closely for any signs of toxicity or adverse reactions.

Management of overdosage should involve immediate assessment of the patient's condition. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. In cases of suspected overdosage, healthcare providers are advised to contact a poison control center or seek specialized medical assistance to determine the appropriate course of action.

Prompt intervention and adherence to established protocols can significantly mitigate the risks associated with overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a poison control center for guidance. This information is vital for ensuring patient safety and preventing serious health consequences.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident cap. It is essential to ensure that the cap remains intact; do not use the product if the tamper-proof cap is open or broken.

Storage conditions require the product to be kept at room temperature. If reconstitution is necessary, the product should be refrigerated and shaken before use. It is important to note that the product should not be used after 36 hours of reconstitution. Additionally, the product must be kept out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Pen Prep, 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 Pen Prep, 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.