NDC 68196-395 Epsom Salt

Magnesium Sulfate

NDC Product Code 68196-395

NDC Product Information

Epsom Salt with NDC 68196-395 is a a human over the counter drug product labeled by Sam's West, Inc. The generic name of Epsom Salt is magnesium sulfate. The product's dosage form is granule and is administered via oral; topical form.

Labeler Name: Sam's West, Inc

Dosage Form: Granule - A small particle or grain.

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.


Epsom Salt 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 SULFATE, UNSPECIFIED 1 g/g

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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

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: Sam's West, Inc
Labeler Code: 68196
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’.

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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 100%

Purpose

Saline laxative

Uses

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

Ask A Doctor Before Use If You Have

  • Kidney disease
  • A magnesium restricted diet
  • Stomach pain, nausea or vomiting
  • Noticed a sudden change in bowel habits that lasts more than 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

Presently taking a prescription drug.

When Using This Product

  • Do not use more than directed

Stop Use And Ask A Doctor If

  • You have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.you need to use a laxative for more than 1 week

If Pregnancy 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

  • Do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hoursagedose adults and children 12  years and older 2-4 level teaspoons dissolved in a full glass (8oz) of water  children 6 to 11 years1-2 level teaspoons in a full glass (8oz) of waterNot recommended for children under 6 years of age.

Inactive Ingredients

None

Other Information

  • Each teaspoon contains: magnesium 493 mg

Package Label

MEMBER'S MARK Epsom Salt

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