EPSOM SALT- magnesium sulfate granule, for solution

Epsom Salt by

Drug Labeling and Warnings

Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Target Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each teaspoon)

Magnesium Sulfate (Epsom Salt) 5 g

Purpose

External Use ...................................................... Soaking Solution
Internal Use .......................................................... Saline Laxative

Uses

External

temporarily relieves minor sprains and bruises

Internal

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 solution

• redness 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 physician

As a laxative
abdominal pain

• nausea
• vomiting
• kidney disease
• a sudden change in bowel habits that lasts over 2 weeks
• a 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

SPL UNCLASSIFIED SECTION

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 1-800-910-6874

Distributed by Target Corporation

Minneapolis, MN 55403

Inactive ingredient

None

PRINCIPAL DISPLAY PANEL

UP & UP

EPSOM SALT

magnesium sulfate USP

NET WT 4 LB (1.8kg)

NET WT 8 LB (3.6kg)

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-200
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-200-45	1800 g in 1 POUCH; Type 0: Not a Combination Product	01/15/2019
2	NDC: 11673-200-46	3682 g in 1 POUCH; Type 0: Not a Combination Product	01/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/15/2019

Labeler - Target Corporation (006961700)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth Inc		080086802	manufacture(11673-200)