NDC 56062-329 Magnesium Citrate

Magnesium Citrate

NDC Product Code 56062-329

NDC Product Information

Magnesium Citrate with NDC 56062-329 is a a human over the counter drug product labeled by Publix Supermarkets, Inc.. The generic name of Magnesium Citrate is magnesium citrate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Publix Supermarkets, Inc.

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 Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)

Administration Route(s)

Additional informationCallout TooltipWhat 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.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Publix Supermarkets, Inc.
Labeler Code: 56062
FDA Application Number: part334 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-28-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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’.

* Please review the disclaimer below.

Magnesium Citrate Product Label Images

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.

Purpose

Saline laxative

Uses

  • 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 last 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.

Directions

  • Drink a full glass (8 ounces)  of liquid with each dosemay be taken as a single daily dose or in divided dosesadults and children 12 years of age and over1/2 bottle to 1 bottle (10 fl oz) children 6 to 11 years of age 1/3 bottle to 1/2 bottlechildren under 6 years of age consult a doctor

Other Information

  • Each fluid ounce contains: magnesium 280 mg, sodium 37 mgstore between 46-86ºF(8-30ºC) Do not refrigerate.protect from excessive heat and freezingdiscard unused product within 24 hours of opening bottle

Inactive Ingredients

Citric acid, flavors, purified water, saccharin sodium, sodium bicarbonate

Package Label

PUBLIX Magnesium Citrate Lemon Flavor

* Please review the disclaimer below.

Previous Code
56062-326
Next Code
56062-332