Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID b1222ba6-390d-478d-905b-994fff4d6d58
Routes
ORAL TOPICAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-30
Description

Magnesium sulfate USP 100%

Purpose

 Saline laxative

Medication Information

Purpose

 Saline laxative

Description

Magnesium sulfate USP 100%

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours
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.
Package Label
TOPCARE HEALTH Epsom Salt
Active Ingredient

Magnesium sulfate USP 100%

Other Information
  • each teaspoon contains: magnesium 495 mg
Inactive Ingredient

 none

Principal Display Panel

Epsom Salt

MAGNESIUM SULFATE U.S.P.

  • Saline Laxative for Relief of Occasional Constipation 
  • Soaking Aid for Minor Sprain and Bruises

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

[email protected]

www.topcarebrand.com

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.

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.

Structured Label Content

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

 Saline laxative

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.
Package Label
TOPCARE HEALTH Epsom Salt
Active Ingredient (Active ingredient)

Magnesium sulfate USP 100%

Other Information (Other information)
  • each teaspoon contains: magnesium 495 mg
Inactive Ingredient (Inactive ingredient)

 none

Principal Display Panel

Epsom Salt

MAGNESIUM SULFATE U.S.P.

  • Saline Laxative for Relief of Occasional Constipation 
  • Soaking Aid for Minor Sprain and Bruises

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

[email protected]

www.topcarebrand.com

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

 ask a health professional before use.

Keep Out of Reach of Children. (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.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

 presently taking a prescription drug.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.770857 · Updated: 2026-03-14T23:09:18.179019