EPSOM SALT- magnesium sulfate granule 
TOP CARE (Topco Associates LLC)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Magnesium sulfate USP 100%

Purpose

 Saline laxative

Uses

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

agedose
 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

Inactive ingredient

 none

Principal Display Panel

Epsom Salt

MAGNESIUM SULFATE U.S.P.

NET WT OZ (LB)

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topcare.com

www.topcarebrand.com

Package Label

Magnesium Sulfate USP 100%

TOPCARE HEALTH Epsom Salt

EPSOM SALT 
magnesium sulfate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-395
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-395-01454 g in 1 CARTON; Type 0: Not a Combination Product04/30/2014
2NDC:36800-395-041810 g in 1 CARTON; Type 0: Not a Combination Product04/30/2014
3NDC:36800-395-10454 g in 1 POUCH; Type 0: Not a Combination Product04/30/2014
4NDC:36800-395-401814 g in 1 POUCH; Type 0: Not a Combination Product04/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/30/2014
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 12/2022
Document Id: 7ec9e304-61fc-4236-9ab1-2ed6035240d2
Set id: b1222ba6-390d-478d-905b-994fff4d6d58
Version: 8
Effective Time: 20221216
 
TOP CARE (Topco Associates LLC)