NDC 49035-602 Epsom Salt

Magnesium Sulfate

NDC Product Code 49035-602

NDC Product Information

Epsom Salt with NDC 49035-602 is a a human over the counter drug product labeled by Walmart, Inc. The generic name of Epsom Salt is magnesium sulfate. The product's dosage form is granule, for solution and is administered via oral; topical form.

Labeler Name: Walmart, Inc

Dosage Form: Granule, For Solution - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.

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 HEPTAHYDRATE 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: Walmart, Inc
Labeler Code: 49035
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: 03-11-2019 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.

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

Tep

Tamper Evident Packaging:Caution:  This package has been sealed for your protection.  Do not use if package is open, torn or mutilated.

Active Ingredient

Magnesium sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative

Use

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

Warnings

For this product

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.

If Pregnant Or Breast-Feeding

Ask a help professional before use.

Keep Out Of Reach Of Children

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

Directions

  • Do not exceed recommended daily dosagedrink a full glass (8 ounces) of liquid with each dosemay be taken as a single daily dose or in divided dosesdissolve 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

Other Information

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

Soaking Directions

For external use as a soaking aid for minor sprains and bruises.DIRECTIONS:  For a relaxing bath/soak, generously sprinkle Equate Epsom Salt into warm, running bath waterCAUTION:  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 phsician.  Keep out of reach of children.

Adverse Reactions Section

DISTRIBUTED BY: Walmart, Inc. Bentonville, AR 72718602.002/602AA

* Please review the disclaimer below.

Previous Code
49035-601
Next Code
49035-603