NDC 55910-648 Epsom Salt

Magnesium Sulfate

NDC Product Code 55910-648

NDC 55910-648-80

Package Description: 3630 g in 1 POUCH

NDC Product Information

Epsom Salt with NDC 55910-648 is a a human over the counter drug product labeled by Old East Main Co.. The generic name of Epsom Salt is magnesium sulfate. The product's dosage form is granule and is administered via oral form.

Labeler Name: Old East Main Co.

Dosage Form: Granule - A small particle or grain.

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.

Epsom Salt 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 SULFATE HEPTAHYDRATE 1 g/g

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: Old East Main Co.
Labeler Code: 55910
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: 11-02-2020 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: 12-31-2021 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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Epsom Salt Product Label Images

Epsom Salt 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 sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative

Uses

•for relief of occasional constipation (irregularity)•this product generally produces bowel movement in 1/2 to 6 hours

Warnings

Warnings

Ask A Doctor Before Use If You Have

  • Kidney diseasea magnesium-restricted dietabdominal pain, nausea, or vomitingnoticed a sudden change in bowel habits that persists over a period of 2 weeksalready used a laxative for a period longer than 1 week

Ask A Doctor Or Pharmacist Before Use If You Are

Taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Stop Use And Ask A Doctor If

You have rectal bleeding or failure to have a bowel movement after use.  These could be signs of a serious condition.

Directions

•do not exceed recommended daily dosage•drink a full glass (8 ounces) of liquid with each dose•may be taken as a single daily dose or in divided doses•dissolve the dose in 8 ounces of water.  lemon juice may be added to improve the tasteadults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) dailychildren 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) dailychildren under 6 years - consult a doctor

Keep Out Of Rech Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information

•each teaspoon (5 grams) contains: magnesium 495 mg

Guaranteed Analysis

Magnesium (Mg) .........................................9.8% - 9.8% Soluble Magnesium (Mg)Sulfur (S)......................................................12.9% - 12.9% Combined Sulfur (S)Derived from: magnesium sulfateF-1253Information regarding the contents and levels of metals in this product is available on the Internet at:http.//agr.wa.govGUARANTEED BY: Vi-Jon, Inc8515 Page Ave.St. Louis, MO 63114

Other

Tamper evident Packaging:Caution: This package has been sealed for your protection. Do not use if package is open, torn or mutilated.For Salaine Laxative see DirectionsFor external use as a soaking aid for minor sprains and bruisesDirections: Dissolve 2 cupfuls of tis product per gallon of water. Apply with bandagesor toweling for 30 minutes up to three times a day, or use as a soak or in bath.Use warm water for best results.Caution: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician. Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician.Directions for use (fertilizer)for use as a fertilizer apply at the following rates:Lawns:Apply at a rate of 1/2 pound per one thousand square feet of lawn.For use as a plant food supplement apply at the following rates:Tomatoes,Roses - One teaspoon per foot plant height every two weeks.Evergreens, Azaleas, Rhododendrons- apply one tablespoon per nine sq. ft. (3' x 3') over the root zone every two to for weeks.Garden Plants and Shrubbery - Sprinkle 2 tablespoons around the base of each plant.Trees - Apply two tablespoons per nine sq. ft. (3' x3') over root zone once every four months.Garden Startup - Sprinkle approximately one cup per 100 sq. ft. (10' x 10') and mix ito soil prior to planting.Houseplants - Mix one teaspoon per gallon of water and feed to plants every one to four weeks.For quicker results water plants after applying this product.DISTRIBUTED BY OLD EAST MAIN CO.100 MISSION RIDGEGOODLETTSVILLE, TN 37072

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