EPSOM SALT- magnesium sulfate granule

Epsom Salt by

Drug Labeling and Warnings

Epsom Salt by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Magnesium sulfate USP 100%

Purpose

 Saline laxative

Uses

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

Warnings

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 pregnant 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 hours

• age: dose
• adults and children 12 years and older: 2-4 level teaspoons dissolved in a full glass (8oz) of water
• children 6 to 11 years:

  1-2 level teaspoons in a full glass (8oz) of water

Not recommended for children under 6 years of age.

Other information

• each teaspoon contains: magnesium 495 mg

Inactive ingredient

 none

Principal Display Panel

FOR HEALTH & BEAUTY

Epsom Salt

MAGNESIUM SULFATE USP

• a soaking aid for minor sprains & bruises
• a saline laxative for the short-term relief of constipation

NET WT OZ (LB)

TAMPER EVIDENT: DO NOT USE IF HEAT SEALED CARTON IS IMPROPERLY SEALED.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

©ELK GROVE VILLAGE, IL 60007

TOPCO PLV1117

topcare@topcare.com

www.topcarebrand.com

Package Label

TOPCARE Epsom Salt

INGREDIENTS AND APPEARANCE

EPSOM SALT 
magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-395
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-395-01	454 g in 1 CARTON; Type 0: Not a Combination Product	04/30/2014
2	NDC: 36800-395-04	1810 g in 1 CARTON; Type 0: Not a Combination Product	04/30/2014
3	NDC: 36800-395-10	454 g in 1 POUCH; Type 0: Not a Combination Product	04/30/2014
4	NDC: 36800-395-40	1814 g in 1 POUCH; Type 0: Not a Combination Product	04/30/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	04/30/2014

Labeler - TOP CARE (Topco Associates LLC) (006935977)