NDC 56062-329 Magnesium Citrate
Magnesium Citrate
NDC Product Code 56062-329
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.
Code Structure
- 56062 - Publix Supermarkets, Inc.
- 56062-329 - Magnesium Citrate
NDC 56062-329-10
Package Description: 296 mL in 1 BOTTLE, GLASS
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
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.
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.
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
- SODIUM BICARBONATE (UNII: 8MDF5V39QO)
- WATER (UNII: 059QF0KO0R)
- SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
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.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Code: 56062
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: 02-28-2019
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’.
* 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
- Purpose
- Uses
- Do Not Use
- Ask A Doctor Before Use If You Have
- Ask A Doctor Or Pharmacist Before Use If You Are
- When Using This Product,
- Stop Use And Ask A Doctor If
- If Pregnant Or Breast-Feeding,
- Keep Out Of Reach Of Children.
- Directions
- Other Information
- Inactive Ingredients
- Package Label
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.