NDC 41520-326 Magnesium Citrate

Magnesium Citrate

NDC Product Code 41520-326

NDC CODE: 41520-326

Proprietary Name: Magnesium Citrate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Magnesium Citrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to clean stool from the intestines before surgery or certain bowel procedures (e.g., colonoscopy, radiography), usually with other products. It may also be used for relief of constipation. However, milder products (e.g., stool softeners, bulk-forming laxatives) should be used whenever possible for constipation. Magnesium citrate is a saline laxative that is thought to work by increasing fluid in the small intestine. It usually results in a bowel movement within 30 minutes to 3 hours.

NDC Code Structure

  • 41520 - Care One (american Sales Company)

NDC 41520-326-10

Package Description: 296 mL in 1 BOTTLE, GLASS

NDC Product Information

Magnesium Citrate with NDC 41520-326 is a a human over the counter drug product labeled by Care One (american Sales Company). The generic name of Magnesium Citrate is magnesium citrate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Care One (american Sales Company)

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Magnesium Citrate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM CITRATE 1.745 g/29.6mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Care One (american Sales Company)
Labeler Code: 41520
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-31-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients


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Magnesium Citrate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Magnesium citrate 1.745g per fl. oz.


Saline laxative


  • Relieves occasional constipation (irregularity)generally produces bowel movement in 1/2 to 6 hours

Do Not Use

Laxative products for longer than 1 week unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • Kidney diseasea magnesium restricted dieta sodium restricted dietstomach pain, nausea, or vomitingnoticed a sudden change in bowel habits that lasts more than 1 week

Ask A Doctor Or Pharmacist Before Use If You Are

Presently taking a prescription drug.

When Using This Product,

Do not exceed the maximum recommended daily dosage in a 24 hour period.

Stop Use And Ask A Doctor If

You have rectal bleeding or no bowel movement after use. these could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Adults and children 12 years of age and older 1/2 to 1 bottle (10 fl. oz.). Drink a full 8 oz. glass of liquid with each dose. The dose may be taken as a single daily dose or in divided doses.  children 6 to 11 years of age  1/3 to 1/2 bottle with a full 8 oz. glass of liquid children under 6 years of age  consult a doctor

Other Information

  • Each fluid ounce contains: magnesium 282 mg, sodium 37 mgstore between 46-86ºF (8-30ºC). Do not refrigerateprotect from excessive heat and freezingdiscard unused product within 24 hours of opening bottle

Inactive Ingredients

Citric acid, FD&C red #40, flavors, purified water, saccharin sodium, sodium bicarbonate

Package Label

CareOne Magnesium Citrate Cherry Flavored

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