NDC 11673-200 Epsom Salt

Magnesium Sulfate

NDC Product Code 11673-200

NDC Product Information

Epsom Salt with NDC 11673-200 is a a human over the counter drug product labeled by Target Corporation. 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: Target Corporation

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: Target Corporation
Labeler Code: 11673
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: 01-15-2019 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

Active Ingredient (In Each Teaspoon)

Magnesium Sulfate (Epsom Salt) 5 g

Purpose

External Use ...................................................... Soaking SolutionInternal Use .......................................................... Saline Laxative

Uses

External• temporarily relieves minor sprains and bruisesInternal• relieves occasional constipation (irregularity)• generally produces bowel movement in 1/2 to 6 hours

Warnings

As a laxative • Do not give to children under six years of age except under the advice and supervision of a physician.• For occasional use only. Serious side effects from prolonged use or overdose may occur.

Ask A Doctor Before Use If You Have:

  • As a soaking solutionredness or swelling present • evidence of an infection • diabetes - hot and warm soaks should not be used by individuals with diabetes except on advice of a physicianAs a laxative • abdominal painnauseavomitingkidney diseasea sudden change in bowel habits that lasts over 2 weeksa magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are:

As a laxative • taking prescription medication

When Using This Product

• do not use more than directed

Stop Use And Ask A Doctor If:

As a soaking solution• you experience redness, irritation, swelling or infection.As a laxative• you have no bowel movement within six hours or experience rectal bleeding - these could be signs of a serious condition.• you have already used a laxative for longer than one week.

If Pregnant Or Breastfeeding

Consult a health care professional before use.

Keep Out Of Reach Of Children.

In case of accidental ingestion or overdose, seek medical attention or contact a Poison Control Center immediately.

Directions

As a soaking solution: Pour 2 cups of Epsom Salt under warm, running bath water. Soak for 20 minutes to relieve sore, tired muscles.As a warm compress: Dissolve 1 cup of Epsom Salt in 1 quart of warm water. Using a towel, apply solution to the affected area for 15-30 minutes to reduce pain and swelling. Repeat as needed.As a laxative: If necessary, repeat dosage after 4 hours. Do not take more than 2 doses per day. Drink a full 8 oz of water with each dose.adults and children 12 years of age and older .......................1-3 level teaspoons dissolved in a full glass (8oz) of water daily.children 6 to 12years of age ............................1/2-1 level teaspoons dissolved in a full glass (8oz) of water daily.Not recommended for children under 6 years of age

Other Information

Dissolve well before use.magnesium content: 495 mg per teaspoon (5 grams)

Questions?

Call 1-800-910-6874

Other

Up & up™ epsom salt features 100% pure magnesium sulfate to rejuvenate tired, sore, achy muscles without any overpowering scents. It can also be used as a saline laxative to help loosen bowels and help relieve occasional constipation.We welcome any questions you may have at Target.com/comments or 1-800-910-6874Distributed by Target CorporationMinneapolis, MN 55403

Inactive Ingredient

None

Principal Dispaly Panel

Tear along dotted line and press zipper to resealTAMPER EVIDENT: DO NOT USE IF HEAT-SEALED POUCH IS IMPROPERLY SEALED OR TORN.EPSOM SALTmagnesium sulfate USPsaline laxative helps relieve occasional digestive distresssoaking solution helps ease sore and tired musclesUP & UPNET WT 4 LB (1.8kg)NET WT 8 LB (3.6kg)

* Please review the disclaimer below.

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