drug facts

drug facts
SPL v10
SPL
SPL Set ID 1515fadd-a7a5-4502-afe2-cfcd50d5bfc8
Routes
oral topical
Published
Effective Date 2025-07-11
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 2017-12-31 Until 2024-03-28

Purpose

 Saline laxative

Description

Magnesium sulfate USP 100%


Medication Information

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 dissolved in a full glass (8oz) of water



Not recommended for children under 6 years of age.
Other Information
  • each teaspoon contains: magnesium 495 mg
  • store in a cool dry place out of direct sunlight
Description

Magnesium sulfate USP 100%

Principal Display Panel

Epsom salt

Magnesium Sulfate

Multi use product

Most commonly used as an aid

in soaking minor sprains & bruises

Saline laxative for the short term relief of constipation

SALINE LAXATIVE

Net Wt LB (kg)

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

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

Package Label
SUNMARK Epsom Salt
Active Ingredient

Magnesium sulfate USP 100%

Inactive Ingredient

none 

Questions Or Comments?

For laxative or soak, call 1-833-358-6431 Monday- Friday 9AM-7PM EST

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
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.

If Pregnancy Or Breast Feeding,

 ask a health professional before use.

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 dissolved in a full glass (8oz) of water



Not recommended for children under 6 years of age.
Other Information (Other information)
  • each teaspoon contains: magnesium 495 mg
  • store in a cool dry place out of direct sunlight
Principal Display Panel

Epsom salt

Magnesium Sulfate

Multi use product

Most commonly used as an aid

in soaking minor sprains & bruises

Saline laxative for the short term relief of constipation

SALINE LAXATIVE

Net Wt LB (kg)

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

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

Package Label
SUNMARK Epsom Salt
Active Ingredient (Active ingredient)

Magnesium sulfate USP 100%

Inactive Ingredient (Inactive ingredient)

none 

Questions Or Comments? (Questions or comments?)

For laxative or soak, call 1-833-358-6431 Monday- Friday 9AM-7PM EST

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
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.

If Pregnancy Or Breast Feeding, (If pregnancy or breast-feeding,)

 ask a health professional before use.

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

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