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Epsom Salt by TOP CARE (Topco Associates LLC)

Medically reviewed on January 22, 2018

Dosage form: granule
Ingredients: MAGNESIUM SULFATE, UNSPECIFIED 1g in 1g
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-395

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.

Drug Facts

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
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
  • 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

EPSOM SALT 
magnesium sulfate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-395
Route of AdministrationORAL, TOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE, UNSPECIFIED (MAGNESIUM CATION) MAGNESIUM SULFATE, UNSPECIFIED1 g  in 1 g
Packaging
#Item CodePackage Description
1NDC:36800-395-01454 g in 1 CARTON
2NDC:36800-395-041810 g in 1 CARTON
3NDC:36800-395-10454 g in 1 POUCH
4NDC:36800-395-401814 g in 1 POUCH
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)

 
TOP CARE (Topco Associates LLC)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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